Lexaria Announces FDA Clearance for its Planned U.S. Phase 1b Hypertension Clinical Trial
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The FDA's clearance of Lexaria's IND application for a Phase 1b hypertension clinical trial represents a pivotal step in the development of DehydraTECH-CBD. This technology's potential to offer a novel mechanism of action in hypertension treatment could address a significant unmet medical need. Current anti-hypertensive drugs target various pathways, but resistance or suboptimal response in some patients necessitates ongoing research for innovative treatments.
DehydraTECH-CBD's interaction with the human sympatho-chromaffin system, particularly through catestatin modulation, suggests a differentiated approach compared to existing therapies. This could be particularly advantageous for patients who have not responded adequately to current treatment options. The safety profile noted in previous studies, with no serious adverse events, is also promising, as safety concerns are paramount in drug development.
It is important to note that while the initial clinical data appears encouraging, further extensive testing is required to validate efficacy and safety. The Phase 1b trial outcome will be critical in determining DehydraTECH-CBD's viability as a therapeutic option and its potential impact on the treatment landscape for hypertension.
The progression of Lexaria's clinical trials is an important indicator for investors tracking the biotechnology sector. The successful navigation of FDA regulatory hurdles to reach a Phase 1b trial not only validates the company's research capabilities but also enhances its credibility and potential attractiveness to partners or acquirers.
Investors should consider the competitive landscape of hypertension treatments, where innovation can lead to significant market share. Given the prevalence of hypertension globally and the demand for safer, more effective drugs, Lexaria's DehydraTECH-CBD, if successful, could capture a substantial portion of this market. However, the pharmaceutical industry is characterized by high risk and high reward and the outcome of clinical trials is uncertain until all data are collected and analyzed.
Furthermore, the company's mention of the need to raise sufficient funding to commence the study introduces a degree of financial uncertainty. Investors should monitor the company's ability to secure the necessary capital, as any delays or difficulties in funding could impact the trial's timeline and the company's stock performance.
The FDA's acceptance of Lexaria's IND application is a significant milestone that can have material implications for the company's financial future. It may lead to increased investor confidence and potentially enhance stock valuation, as it marks a transition from pre-clinical to clinical stages of drug development, which is often seen as de-risking the investment proposition.
However, it is crucial to analyze the company's financial health and its ability to fund ongoing research and development. The cost of clinical trials can be substantial and the company's statement about the necessity of raising additional funds suggests that current capital may not be sufficient to cover these expenses. This could lead to dilution for current shareholders if the company opts for equity financing.
Investors should also scrutinize the company's burn rate and runway, comparing it to industry norms and evaluating how any potential delays or cost overruns could affect the company's financial position and its ability to reach key milestones within expected timelines.
KELOWNA, BC / ACCESSWIRE / March 1, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces that the U.S. Food and Drug Administration ("FDA") has confirmed effectiveness as of February 28, 2024 of the Company's investigational new drug ("IND") application thereby cleared for Lexaria to conduct its planned U.S. Phase 1b hypertension clinical trial HYPER-H23-1 utilizing DehydraTECH-CBD.
"This is a significant milestone achievement for Lexaria demonstrating, for the first time, that its DehydraTECH technology meets the FDA's high level of regulatory scrutiny sufficient to formally commence U.S. registrational clinical testing towards possible future pharmaceutical commercialization," said John Docherty, president of Lexaria. "We look forward to commencing this important clinical trial and building upon the wealth of early-stage clinical data we have gathered and presented to the FDA to-date demonstrating the safety, efficacy and novel mechanistic performance of DehydraTECH-CBD in hypertensive patients."
Lexaria is pleased to have complied with the FDA's rules and procedures for clearance to perform this important registrational trial. The Company will further announce when it is ready to begin the study, subject to certain conditions including raising sufficient funding.
Background and Medical/Market Rationale
From 2018 through 2022, Lexaria has previously conducted five human clinical studies of DehydraTECH-CBD in an aggregate total of 134 healthy normal and hypertensive volunteers, without recording a single serious adverse event (the "Studies"). The 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 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 journal, "Biomedicine and Pharmacotherapy". This is significant because the FDA has previously communicated 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.
About Planned Clinical Trial HYPER-H23-1
Clinical trial 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 trial will be to evaluate safety and tolerability in hypertensive patients, and secondary objectives will include efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing.
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 39 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, the intended use of proceeds from the offering, and 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
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
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