Author Archives: mmcdonald

900% and 2,000% improvements in peak bloodstream delivery using DehydraTECH

KELOWNA, BC / May 18, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that its animal study HOR-A22-1 has successfully completed, showing significant enhancement in the oral delivery of the estrogen hormone estradiol, an important component of therapeutic products in the women's health sector.

The DehydraTECH-estradiol formulation achieved an average peak concentration in the bloodstream (or "Cmax") of 5.65ng/mL that was roughly nine times (900%) higher than that achieved with the control formulation at only 0.63 ng/mL. As well, because estradiol is known to be quickly converted into the metabolite estrone by cells in the uterus, mammary glands and liver, estrone levels were also quantified in the study. This revealed that levels of the estrone metabolite were also significantly higher comparing an average Cmax of 6.49 ng/mL with the DehydraTECH formulation to only 0.302 ng/mL achieved with the control, representing greater than a twenty-fold (2,000%) improvement in delivery.

https://storage.googleapis.com/accesswire/media/755703/Image-1.jpg
Average Estradiol and Estrone Cmax in Blood Plasma Following DehydraTECH-Estradiol and Control Administration

Also, the total estradiol and estrone recovery in the blood plasma over time or the Area Under the Curve ("AUC") was dramatically higher at 3.9 hr·ng/mL for estradiol and 32.6hr·ng/mL for the estrone with the DehydraTECH composition versus being non-detectable below the lower limit of quantitation of the assay (i.e., 0.25 ng/mL) with the control in both instances. This means that the AUC findings were at least fifteen times (1,500%) greater than the control for estradiol and over one hundred and twenty-five times (12,500%) greater for estrone.

Oral estradiol therapy is commonly used by women in birth control products, as well as to help reduce the symptoms of menopause and protect bone health. The hormone replacement market is estimated at $46.5 billion in 2027.

Oral estradiol formulations are known to have very low bioavailability, generally in the 5% range, necessitating relatively high dosages to achieve the desired beneficial effects. This, in turn, can lead to unwanted side effects ranging from gastrointestinal complications such as nausea, vomiting, diarrhea, stomach cramps and bloating, to other issues such as headache, dizziness, rash and more. Lexaria's DehydraTECH processing may offer a new approach to formulating estradiol and potentially other human hormone therapies for enhanced oral delivery toward improved safety and efficacy if pursued and proven ultimately clinically in humans.

According to a study just published in the Canadian Medical Association Journal, "menopause and perimenopause can be associated with distressing symptoms and reduced quality of life". As reported by CTV News, "more women suffering from debilitating symptoms of menopause should be presented with the option of hormonal therapy".

About Estrogen

There are three main types of Estrogen: They are Estrone (E1) which is the only estrogen that females continue to make after menopause and which males and females manufacture in the adrenal glands; Estradiol (E2) which is the most common form of estrogen in women of childbearing age and is primarily made in the ovaries, and in men, is manufactured in very small quantities in the testicles; and Estriol (E3) that is primarily made in the placenta of pregnant women.

About the Study

Study HOR-A22-1 was a pharmacokinetic ("PK") study performed in twenty female Sprague-Dawley rats in order to evaluate the ability of DehydraTECH™ to enhance the delivery characteristics of orally administered estradiol. Delivery was assessed comparing a DehydraTECH-estradiol composition to a concentration-matched generic estradiol preparation lacking the DehydraTECH formulation and processing enhancements. Formulations were administered orally at a dose of 10 mg/kg of estradiol. Following dosing, blood was collected up to 48 hours post-dose. The concentration of estradiol and estrone were then determined in plasma following dosing using a validated liquid chromatography tandem mass spectrometry "LC-MS/MS") method.

Study HOR-A22-1 was conducted at a U.S.-based, third-party independent laboratory. Lexaria will provide additional information of further developments or plans to pursue expanded investigation with DehydraTECH for human hormone therapies as they become available.

About DehydraTECH

DehydraTECH is a patented drug delivery formulation and processing platform technology Lexaria has developed and is investigating for a variety of beneficial molecules. DehydraTECH is designed to improve the way active molecules enter the bloodstream upon oral ingestion. DehydraTECH has also demonstrated enhanced delivery of certain active molecules into brain tissue, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria has also developed DehydraTECH formulations for other applications demonstrating superior bio-absorption when administered intraorally and topically.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 30 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/755703/Lexarias-Hormone-Study-Shows-Significant-Enhancement-in-Oral-Estradiol-Delivery

KELOWNA, BC / May 11, 2023 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, today announced the closing of its public offering of 2,106,000 units, with each unit consisting of one share of common stock and one warrant to purchase one share of common stock. Each unit was sold at a public offering price of $0.95. The warrants in the units are immediately exercisable at a price of $0.95 per share and expire five years from the date of issuance. The shares of common stock and accompanying warrants were only purchasable together in this offering, but were issued separately and were immediately separable upon issuance.

Gross proceeds, before deducting placement agent fees and other offering expenses, were approximately $2.0 million.

Maxim Group LLC acted as sole placement agent in connection with this offering.

The securities described above were offered pursuant to a registration statement on Form S-1, as amended (File No. 333-271096) (the "Registration Statement"), which was declared effective by the Securities and Exchange Commission (the "SEC") on May 8, 2023. The offering was made only by means of a prospectus which is a part of the Registration Statement. A copy of the final prospectus relating to the offering has been filed with the SEC and may be obtained from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, NY 10022, at (212) 895-3745.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 30 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

Forward-Looking Safe Harbor Statement

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Investor Contact:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/754344/Lexaria-Bioscience-Announces-Closing-of-20-Million-Public-Offering

KELOWNA, BC / May 10, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces the results of the 2023 Annual Meeting (the "Meeting").

On May 9, 2023 at 1:00 p.m. (Pacific Time), the Company held the Meeting whereby there were 3,372,024 shares of the Company represented in person or by proxy at the meeting, constituting 56.3% of the Company's issued share capital as at March 13, 2023, being the record date of the Meeting. The matters voted upon at the Meeting and the final voting results are set forth below:

Matter Being Voted On

For

Against/Withheld

Abstain

Broker Non-Vote

Percent Approved By1

To Elect Chris Bunka as a director

2,141,964

77,489

1,152,571

96.5%

To Elect John Docherty as a director

2,137,546

81,907

1,152,571

96.3%

To Elect Nicholas Baxter as a director

1,648,288

571,165

1,152,571

74.3%

To Elect Ted McKechnie as a director

2,123,869

95,584

1,152,571

95.7%

To Elect Albert Reese Jr. as a director

2,134,837

84,683

1,152,504

96.2%

To Elect Dr. Catherine Turkel as a director

2,165,426

54,027

1,152,571

97.6%

To Appoint Malone Bailey LLP as Auditors

3,249,199

105,067

17,758

96.4%

To Approve the Stock Option Repricing

1,529,271

677,686

12,429

1,152,638

68.9%

To Approve the Amendment to the Maxim Number of Shares Issuable pursuant to the Incentive Equity Plan

1,965,779

249,519

4,155

1,152,571

88.6%

To Approve the Addition of an Evergreen Formula to the Incentive Equity Plan

1,400,723

709,940

108,790

1,152,571

63.1%

To Ratify the lawful actions of the directors for the past year

2,005,926

156,382

57,145

1,152,571

90.4%

1 Percentage is calculated based on abstained votes being counted as a vote against the resolution

All of the proposals are described in detail in the Company's proxy statement filed with the Securities Exchange Commission via Edgar and with the BC Securities Commission and Ontario Securities Commission via SEDAR on March 22, 2023.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 30 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/753989/Lexaria-Announces-2023-Annual-Meeting-Results

KELOWNA, BC / May 8, 2023 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, today announced the pricing of its public offering of 2,106,000 units, with each unit consisting of one share of common stock (or one pre-funded warrant to purchase one share of common stock in lieu thereof), and one warrant to purchase one share of common stock. Each unit is being sold at a public offering price of $0.95. The warrants will be immediately exercisable at a price of $0.95 per share and will expire five years from the date of issuance. The shares of common stock (or pre-funded warrants in lieu thereof) and accompanying warrants can only be purchased together in this offering, but will be issued separately and will be immediately separable upon issuance.

Gross proceeds, before deducting placement agent fees and other offering expenses, are expected to be approximately $2.0 million. The offering is expected to close on May 11, 2023, subject to customary closing conditions.

Maxim Group LLC is acting as sole placement agent in connection with this offering.

The securities described above are being offered pursuant to a registration statement on Form S-1, as amended (File No. 333-271096) (the "Registration Statement"), which was declared effective by the Securities and Exchange Commission (the "SEC") on May 8, 2023. The offering is being made only by means of a prospectus which is a part of the Registration Statement. A preliminary prospectus relating to the offering has been filed with the SEC. Copies of the final prospectus relating to this offering, when available, will be filed with the SEC and may be obtained from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, NY 10022, at (212) 895-3745.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 30 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

Forward-Looking Safe Harbor Statement
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, the Company's ability to satisfy customary closing conditions related to the offering. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Investor Contact:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/753629/Lexaria-Bioscience-Announces-Pricing-of-20-Million-Public-Offering

KELOWNA, BC / May 8, 2023 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that dosing of the targeted 36 subjects in its human clinical oral nicotine study NIC-H22-1 has been completed.

Human study NIC-H22-1 represents the culmination of several years of work performed by Lexaria on oral nicotine formulations as an alternative to vaping or smoking and may entice the more rapid commercial adoption and distribution of Lexaria's patented DehydraTECH absorption technology in an industry sorely lacking in oral uptake and performance optimizing innovation for many years.

The dangers of cigarette smoking are well known and result in the death of 7 million people per year. Nicotine vaping was originally hoped to help wean people off cigarette use but has had mixed results in doing so, and vaping has also been associated with serious health risks. Nicotine vaping is becoming increasingly controversial and is severely limited in certain countries and was, for instance, just banned in Australia and is either banned or restricted in many other countries. By comparison, Lexaria's DehydraTECH-nicotine is already patent granted for oral nicotine delivery in Australia and pending in numerous other countries. The white pouch category, as tested in study NIC-H22-1, is one of the fastest growing, tobacco-free alternatives to smoking and vaping.

Lexaria's DehydraTECH-powered purified nicotine white pouch formulation contains no tobacco. DehydraTECH-nicotine has already shown in multiple sets of animal testing that it can be up to 10-times to 20-times faster and able to deliver up to 10-fold higher levels of nicotine into blood plasma from oral absorption than concentration matched controls. If the findings from study NIC-H22-1 also show similar improved performance, this could facilitate a more satisfying oral nicotine experience than any of the leading brands sold around the world today which all rely on outdated formulation technology. Speed of onset is of vital importance to nicotine users and Lexaria's DehydraTECH-nicotine has demonstrated superiority in this regard.

Lexaria Bioscience Corp., Monday, May 8, 2023, Press release picture

Nicotine Plasma Levels (ng/mL) - DehydraTECH vs. Control From Lexaria's Earlier Animal Study

The oral nicotine pouch category is of intense interest to Lexaria and the nicotine products industry, and its growth is due in part to its reduced risk health outcomes as noted by the Food and Drug Administration ("FDA"). This delivery method, in the white pouch format specifically, which avoids harmful lung outcomes experienced by smokers or vapers, involves absorption primarily through the buccal and sublingual tissues of the mouth, of purified nicotine that has been separated from most other harmful compounds in the tobacco leaf. The global market for the oral nicotine pouch category was US$2.33 billion in 2020 and is growing at a rapid CAGR of 30.7% and is expected to reach $21.84 billion in 2027.

About Study NIC-H22-1.

Study NIC-H22-1 is a human pharmacokinetic randomized, double blinded, cross-over study conducted in a minimum of 36 human volunteers that are current cigarette smokers, wherein each person visited the laboratory to be dosed three times over several weeks. During each visit only one oral nicotine pouch was administered and evaluated: either DehydraTECH-nicotine; On! brand manufactured by Altria; or Zyn brand manufactured by Swedish Match. While 36 people have to date completed their dosing, Lexaria expects a small number of additional person(s) who were over enrolled into the study to also complete dosing in the immediate future.

The primary study objectives are to determine the quantity of nicotine in blood at various time points and vital-sign data collection including blood pressure, heart rate and respiratory rate. Subjective evaluations related to throat burn, user experience, gastrointestinal experience and more are also being conducted.

The study is fully funded from internal company resources. Sample and data analysis is already underway and will be reported upon as soon as possible and Lexaria will provide further updates and any relevant material findings in due course from this study as they become available.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 30 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/753347/Lexarias-Human-Clinical-Nicotine-Study-Completes-Dosing-as-Planned

Clinical study will evaluate safety and tolerability of Lexaria's patented DehydraTECH-CBD as a potential treatment for hypertension

California-based InClin to provide CRO services to manage and expedite the study

Lexaria is working with its regulatory and clinical advisors toward upcoming IND submission

KELOWNA, BC / April 24, 2023 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces it has awarded the contract for clinical research organization ("CRO") services for its expected upcoming Food and Drug Administration ("FDA")-registered, U.S. Phase 1b Investigational New Drug ("IND") hypertension study HYPER-H23-1 with its patented DehydraTECH-powered cannabidiol ("DehydraTECH-CBD") to California-based InClin, Inc.

Study HYPER-H23-1 is entitled 'A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DehydraTECH-CBD in Subjects with Stage 1 or Stage 2 Hypertension' . The primary objective of the study will be to evaluate safety and tolerability in 120 hypertensive patients, and secondary objectives will include efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing.

InClin is about to begin study start-up and preparatory activities to enable Lexaria to "hit the ground running" with patient dosing as soon as possible after the expected FDA IND filing and review is completed. Lexaria anticipates filing the IND this summer with hoped-for FDA authorization within about 60 days, resulting in the Phase 1(b) trial aggressively targeting commencement of patient dosing as early as October 2023.

The study start-up services to be provided by InClin include but are not limited to: clinical site evaluation and selection, personnel and site training, project management, clinical database design and management, quality assurance support, medical writing, study documentation creation, biostatistics and programming, support vendor coordination, Independent Review Board ("IRB") submissions and more.

Lexaria had a successful outcome following its FDA pre-IND meeting as announced on August 10, 2022. Since then, the Company has been working tirelessly with its regulatory and clinical advisors on refining the study plan and preparing for the IND submission pursuant to the pre-IND guidance it received from the FDA. The Company is in the process of performing the drug product manufacturing and stability testing required as part of the upcoming IND submission, compliant with current Good Manufacturing Practice ("cGMP") regulations. Assembling the stability data from its cGMP-manufactured batch production work is one of the last requirements prior to Lexaria submitting its formal IND application to the FDA this summer.

Lexaria's five previous human clinical studies conducted from 2018 through 2022, which were not conducted under FDA-registration but are expected to be integral to successful filing and review of its upcoming IND submission, were carried out in an aggregate total of 134 healthy and hypertensive persons. These foundational studies evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens, and also produced zero serious adverse events; suggesting that DehydraTECH-CBD has the potential to have pronounced clinical benefits relative to available anti-hypertensive therapeutics.

Lexaria is aware of only a handful of other published research studies, mostly in young, healthy and normotensive volunteers, that have investigated whether a sustained decrease in resting blood pressure is possible following multiple weeks of oral CBD dosing; none of which have been successful in achieving this. DehydraTECH-CBD is currently unique in its evidenced superior power to reduce blood pressure over other oral CBD formulations.

Findings from Lexaria's latest study HYPER-H21-4 demonstrated a potentially novel mechanism of action of DehydraTECH-CBD in reducing blood pressure which may be explained, at least in part, by its interaction with the human sympatho-chromaffin system via catestatin modulation as detailed in the peer-reviewed and published respected journal, " Biomedicine and Pharmacotherapy ". This is of significance because the FDA has previously laid out clear guidelines for sponsors who seek to develop new anti-hypertensive drugs, specifically defining the need for medications that offer novel and complementary modes of action. Data gathered from study HYPER-H21-4 suggested that DehydraTECH-CBD had the potential to offer additive blood pressure reduction benefits on top of any degree of improvements that standard of care medications achieved for patients prior to DehydraTECH-CBD dosing.

About DehydraTECH-CBD

DehydraTECH-CBD is a unique CBD formulation Lexaria has developed and is optimizing based on its patented and proprietary DehydraTECH drug delivery technology. DehydraTECH is designed to improve the way active molecules enter the bloodstream upon oral ingestion. DehydraTECH has also demonstrated enhanced delivery of certain active molecules including CBD into brain tissue, which Lexaria believes to be of particular importance for the effectiveness of its DehydraTECH-CBD specifically against hypertension because of the significant influence of central mediation upon blood pressure. Lexaria has also developed DehydraTECH-CBD formulations for other applications demonstrating superior bio-absorption when administered intraorally and topically.

About InClin, Inc.

InClin is a full-service Contract Research Organization (CRO) with offices in the San Francisco Bay Area and Sydney, Australia. They are a single source provider of an integrated full suite of clinical development services from Phase 1 to Phase 4, including project management, clinical monitoring, site and contract management, vendor management, data management, biostatistics, programming, drug safety, medical monitoring, medical writing, QA inspection readiness, and strategic consulting services. InClin has assembled a team of seasoned professionals and vendor service providers who will support study HYPER-H23-1 for Lexaria, with extensive expertise and experience in the core areas relevant for this program including cardiac safety and efficacy monitoring and pharmacokinetic testing. For more information visit www.InClin.com.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 30 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/750784/Lexaria-Awards-CRO-Contract-for-Upcoming-US-Phase-1b-Hypertension-Study

KELOWNA, BC / April 20, 2023 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has received notifications of four new patents either awarded or allowed.

In Japan, Lexaria has received a new patent under its Patent Family #3: Stable Ready-to-Drink Beverage Compositions Comprising Lipophilic Active Agents. This is Lexaria's 5th awarded patent in Japan, providing strength to our growing Japanese patent portfolio. Lexaria has existing patents under this Patent Family in Australia, India, Japan, and Mexico.

In Australia, Lexaria has received a new patent under its Patent Family #18: Compositions and Methods for Enhanced Delivery of Antiviral Agents. This is Lexaria's 10th patent in Australia and only our second patent in this Patent Family, following a similar patent award in 2022 in the USA.

In Canada, Lexaria has been advised that a new patent under our Patent Family #8: Compositions Infused With Nicotine Compounds and Methods of Use Thereof has been allowed. This is Lexaria's second patent in this Patent Family and follows a similar patent issuance in Australia in 2022.

In the USA, Lexaria has been advised that a new patent under our Patent Family #21: Compositions and Methods for Treating Hypertension has been allowed. Lexaria believes this patent could be of particular importance related to the Company's pursuit of utilizing DehydraTECH-CBD in relation to its expected upcoming FDA Investigational New Drug application. The outcomes of our series of hypertension studies already completed were instrumental in achieving this patent. This will be Lexaria's first patent in this Patent Family.

The global cardiovascular drugs market was worth US$146.5 billion in 2022 and expected to reach $173.5 billion in 2026 and by geography, North America is the biggest market in the world making US patent protection a necessity in the pursuit of commercial markets.

When a patent is "allowed", it means we have been notified by the patent office that they have determined they will soon grant the patent, often subject to some administrative tasks and/or fees. Lexaria is continuously pursuing additional patent protection for its innovative DehydraTECH drug delivery technology. After the awarding of these patents, Lexaria's total patent portfolio will have grown to 32 granted patents worldwide.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 28 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/750248/Lexaria-is-Receiving-Four-New-Patents

KELOWNA, BC / March 2, 2023 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that its diabetes animal model study DIAB-A22-1 has completed and produced at least three positive outcomes including weight loss in obese diabetic-conditioned animals, together with improved triglyceride and cholesterol levels.

REDUCED BODY WEIGHT

Beginning just four days after the start of dosing with DehydraTECH-CBD, the obese rats began to lose weight. The weight loss was maximized nine days after dosing and maintained throughout the 8-week study duration. This apparent trend demonstrated roughly a 7% loss of body weight throughout the course of treatment at both DehydraTECH-CBD doses studied (30 mg/Kg and 100 mg/Kg). Only the DehydraTECH-CBD-dosed animals weighed less at the end of the study than at the beginning, whereas the weight of the untreated obese animals trended upwards throughout the study. The lean untreated animals gained the most weight of all to actually become obese by the end of the study.

Lexaria Bioscience Corp., Thursday, March 2, 2023, Press release picture

Furthermore, in the DehydraTECH-CBD treated rats the weight loss trend observed did not appear to be a result of lower levels of food or water intake. Food and water intake was comparable in both the treated and untreated obese animal groups suggesting that the weight loss was more so related to enhanced metabolic function.

According to the National Institute for Health, obesity or being overweight is the leading cause of diabetes.

ACTIVITY LEVELS

Obesity is often accompanied by reduced activity levels, which were measured in this study via locomotor activity, the distance the animals travelled in open field observations. Interestingly, the lower dose of DehydraTECH-CBD resulted in a statistically significant improvement in locomotor activity compared to the untreated obese control rats (*p<0.05), whereas there was no significant difference accordingly evidenced at the higher dose. As expected, activity levels for all obese rats were significantly lower than the lean control rats (#p<0.05), although only the lower dose DehydraTECH-CBD treated rats approached the activity levels of the lean rats. Previous research has suggested that CBD may enhance motor activity through its action upon the serotonin 5-HT1A receptor.

Lexaria Bioscience Corp., Thursday, March 2, 2023, Press release picture

Additional investigation will be required to learn what an optimum DehydraTECH-CBD dose related to both weight loss and increased physical activity might be, given the fact that the higher dose studied may have elicited sedative-like effects of CBD triggering hypolocomotion which others have also observed upon high systemic exposure.

TRIGLYCERIDE AND CHOLESTEROL LEVELS

Higher triglyceride levels in the blood can be an indication of the onset of diabetes. One of the best ways to manage triglyceride levels is to lose weight. In study DIAB-A22-1, the animals dosed with DehydraTECH-CBD showed statistically significant reductions in triglyceride levels from day 35 onwards compared to the obese animals not dosed with DehydraTECH-CBD. Once again, the lower dose of 30 mg/Kg of DehydraTECH-CBD outperformed the higher dose of 100mg/kg. By the end of the study the triglyceride levels in the animals receiving 30 mg/Kg of DehydraTECH-CBD was over 25% lower than that of the untreated obese animals (*p=0.007).

Lexaria Bioscience Corp., Thursday, March 2, 2023, Press release picture
Lexaria Bioscience Corp., Thursday, March 2, 2023, Press release picture

Cholesterol levels in the animals receiving DehydraTECH-CBD were also higher. There are two types of cholesterol - HDL and LDL - where HDL cholesterol is generally considered "good" and is desired and LDL cholesterol is generally considered "bad", although some studies are beginning to question whether this is true. Again, the lower dose of 30 mg/Kg appeared to outperform the higher 100 mg/Kg dose of DehydraTECH-CBD, with a trend toward increased HDL good cholesterol but with no significant effect upon LDL bad cholesterol levels compared to the untreated obese animals. The 100 mg/Kg dosed animals demonstrated increases in both desired HDL and the undesired LDL levels, with significance relative to the untreated obese animals in the latter instance (*p<0.05). The findings with the lower dose therefore appeared to support improved physiological function relative to the diabetic state.

According to the American Diabetes Association, CBD is not thought to directly reduce blood glucose levels as previous clinical studies have discovered, nor was any significant effect from DehydraTECH-CBD dosing on blood glucose measured or expected in this study.

SUMMARY

Animal study DIAB-A22-1 evidenced, at times, dramatic changes in body weight, general activity, and triglyceride and cholesterol levels associated with administration of DehydraTECH-CBD. These findings are well aligned with other study work in animals that points to the known anti-inflammatory and antioxidant properties of CBD functioning to lessen some of the essential pathophysiological factors associated with diabetes. Lexaria is pleased that relatively low doses of DehydraTECH-CBD seem to be supportive of real improvements in day-to-day health of the lab animals and the Company is very encouraged by the positive findings from its first study of DehydraTECH-CBD in this diabetes animal model, indicating many prospective benefits worthy of further investigation together, perhaps, with other drugs that further help to control glucose levels directly.

ABOUT THE STUDY

Study DIAB-A22-1 administered select Lexaria "DehydraTECH-CBD 2.0" formulations at doses of either 30 mg/Kg or 100 mg/Kg of body weight in a total of 32 male Zucker "ZDF" rats - 24 obese and 8 lean. The study length was doubled from four weeks of dosing to eight weeks of dosing, after initial positive early responses were witnessed. Treatment was well tolerated throughout the course of dosing with no serious health concerns observed in the animals that received DehydraTECH-CBD. The health of some of the obese animals declined after the study had concluded as might be expected, likely as a result of the advanced pathology and possible ketoacidosis from the prolonged diabetic condition of these disease-model animals. Study DIAB-A22-1 was undertaken by a leading, third-party testing laboratory located in Canada.

ABOUT THE DIABETES MARKET OPPORTUNITY

Diabetes is a disease whereby the body does not produce sufficient insulin, leading to higher than normal levels of sugars in the blood. Risks of kidney disease, vision loss, heart and cardiovascular disease and more are greatly enhanced by individuals with diabetes. Because diabetes is often closely connected to obesity, it is a chronic and growing problem around much of the world.

People with type-2 diabetes can often control the disease through lifestyle changes and/or taking certain diabetes medications, whereas those with type-1 diabetes are required to add insulin to their body through syringes, insulin pumps, or other similar devices. Thus the treatment of diabetes includes devices, drugs, and lifestyle alteration. The global diabetes devices market is estimated at $26.7 billion in 2021. The global diabetes drug market is estimated at $63.1 billion in 2021. Due to the pain and unpleasantness of injections, many diabetes sufferers prefer to treat their condition with drugs rather than devices, if they have the choice. More than 1.9 billion people were overweight in 2016, and due to the growth in obesity, which has nearly tripled from 1975 to 2016, the number of people experiencing diabetes continues to grow.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 28 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/741626/Lexarias-DehydraTECH-CBD-Diabetes-Study-Demonstrates-Weight-Loss-Improved-Triglyceride-and-Cholesterol-Levels

KELOWNA, BC / February 21, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce additional findings from its human clinical study HYPER-H21-4 ("the Study") demonstrating a potentially novel mechanism of action of its patented DehydraTECH-processed cannabidiol ("CBD") capsule formulation in reducing blood pressure ("BP").

The Food and Drug Administration ("FDA") has laid out clear guidelines for sponsors who seek to develop new anti-hypertensive drugs, specifically defining the need for medications that offer complementary modes of action. Lexaria believes that its latest results, detailed below and already peer-reviewed and published in the respected journal, "Biomedicine and Pharmacotherapy", may support DehydraTECH-CBD qualification within these FDA guidelines.

Lexaria previously announced that the primary efficacy and safety objectives of the Study were successfully achieved, with resting BP significantly reduced in hypertensive patients, and sustained over the full 5-weeks of dosing with zero serious adverse events being reported throughout the Study. Lexaria is aware of only a handful of other published research studies, mostly in young, healthy and normotensive volunteers, that have investigated whether a sustained decrease in resting BP is possible following multiple weeks of oral CBD dosing; none of which have been successful in achieving this.

Ongoing analyses of the Study data have revealed modulation of a circulating compound called catestatin in the patients. Catestatin is a multifunctional peptide known to have inhibitory effects on the sympathetic nervous system in the pathophysiology of hypertension.

Lexaria Bioscience Corp., Tuesday, February 21, 2023, Press release picture

These analyses (illustrated above) revealed that administration of DehydraTECH-CBD resulted in a statistically significant reduction in average baseline serum catestatin concentrations of 13.50 ng/mL to just 9.65 ng/mL after 5 weeks of dosing, which is a large drop of 28.5% (p < 0.001). There were no statistically significant reductions in catestatin concentrations in the placebo group. As previously reported, mean arterial pressure also dropped significantly by 4.26 ± 1.26 mm/Hg following the 5-week period of DehydraTECH-CBD dosing and this reduction (p = 0.039) was not observed with placebo. The extent of change in catestatin serum levels showed a strong correlation with the reduction in blood pressure (r = 0.71; p < 0.001).

Overall, these latest results from study HYPER-H21-4 imply that the antihypertensive effects of DehydraTECH-CBD may be explained, at least in part, by its interaction with the sympatho-chromaffin system via catestatin modulation. This suggests a potentially unique mechanistic benefit upon cardiovascular regulation with DehydraTECH-CBD treatment that has not previously been demonstrated, to our knowledge, with testing of CBD for blood pressure reduction. CBD is known to have a wide array of distinct effects upon cardiovascular regulation. These include effects upon blood vessel tone, vascular inflammation, blood pressure, and cardiac contractility. The mechanisms of these observations are complex and involves interaction with receptors other than cannabinoid receptors, including actions exerted through various naturally occurring mediator compounds in the body.

There is a clear medical and market need for alternative anti-hypertensive therapies, especially in the case of patients with so-called resistant hypertension who fail to adequately control their high BP with combinations of existing medications. Of note, the decreases in BP evidenced in the Study were similar in both those hypertensive patients on standard of care BP medications and those who were untreated for their hypertension upon Study entry. Therefore, the current results indicate that Lexaria's DehydraTECH-CBD has the potential to offer complementary and additive BP reduction benefits on top of any degree of improvements the standard of care medications provided. This additive improvement of DehydraTECH-CBD as an adjunct therapy, perhaps related to its pronounced effectiveness in modulating catestatin levels, could become a significant value enhancer should it eventually enter the marketplace as an approved hypertension treatment.

Additional study endpoint analyses as described in the complete study protocol are still underway and any relevant material findings will be reported upon as these findings become available.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 28 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Investor Contact:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/740061/Lexaria-Discovers-Potential-Novel-Mechanism-From-Hypertension-Study-HYPER-H21-4

KELOWNA, BC / January 23, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that the former President of GW Pharmaceuticals USA, Julian Gangolli, is joining Lexaria Bioscience Corp as a Strategic Advisor.

"I am excited to be advising Lexaria Bioscience as it has become an established force in the field of improved drug delivery. As with GW Pharmaceutical's innovations in the cannabinoid field, the potential of Lexaria's disruptive drug delivery technology is significant and I hope to assist Lexaria in its commercial development of DehydraTECH for multiple applications," said Julian Gangolli.

"As we intensify our focus during 2023 on commercial execution of our robust DehydraTECH technology portfolio, I am very pleased to welcome Julian with his extensive pharmaceutical experience, to the broadening Lexaria team," said Chris Bunka, CEO of Lexaria.

Julian Gangolli was appointed US President of GW Pharmaceuticals in 2015. He oversaw approval by the US Food and Drug Administration of the first and only pure cannabidiol ("CBD") drug ever approved by the FDA, Epidiolex®, and its subsequent successful commercialization in the USA. This commercial success led ultimately to the acquisition of GW Pharmaceuticals by Jazz Pharmaceuticals in 2021 in a $7.2 billion transaction.

Mr. Gangolli was previously North American President of Allergan and a member of their Executive Management team that oversaw the sale of Allergan to Actavis in 2015. Mr. Gangolli was a senior member of the Allergan management team from 1998 onwards that transformed Allergan into one of the leading specialty pharmaceutical companies in the US.

Stock options valid to purchase 5,000 shares of the Company are being issued to Mr. Gangolli with an exercise price of $2.73 per share, valid for 5 years from the date of issuance.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 28 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/736187/Former-President-of-GW-Pharmaceuticals-USA-Joins-Lexaria-Bioscience-as-Strategic-Advisor