Lexaria's Submits Investigational New Drug Application
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Insights
The submission of an Investigational New Drug (IND) application to the FDA is a critical step in the development of new pharmaceuticals. Lexaria Bioscience Corp.'s IND for the phase 1b hypertension clinical trial of DehydraTECH-CBD represents a significant milestone in the company's pursuit to bring a novel therapeutic option to the market. The fact that prior studies have shown significant reductions in resting blood pressure without serious adverse events suggests a favorable safety profile, which is a crucial factor in the FDA's evaluation process.
From an investment perspective, the success of this IND could catalyze Lexaria's stock value as it would signal a progression towards potential commercialization. However, investors should be aware that the clinical trial process is lengthy and fraught with risk, including the possibility of not meeting efficacy or safety benchmarks in later-stage trials. Moreover, the pharmaceutical industry is highly competitive and Lexaria will need to ensure that its product can differentiate itself effectively.
Lexaria's progression towards the initiation of a phase 1b clinical trial is indicative of its commitment to advancing its drug delivery technology. The IND submission implies that the company is moving forward in its clinical development pathway, which can be a positive signal to investors. However, the company's mention of 'subject to certain conditions including funding' indicates a potential need for additional capital to proceed with the trials. This could result in future equity financing that may dilute current shareholders or the incurrence of debt that could affect the company's financial health.
Furthermore, the outcome of the IND review process will likely have a direct impact on the company's share price. A successful review would validate the company's technology and could lead to strategic partnerships or licensing deals, while a negative outcome could have the opposite effect. Investors should closely monitor the FDA's 30-day review period for any updates or feedback that could influence the company's strategic direction and financial projections.
Within the broader context of the pharmaceutical industry, Lexaria's focus on a hypertension treatment is strategically significant. Hypertension is a common condition with a large patient population, which suggests a substantial market opportunity for DehydraTECH-CBD if it is approved. The company's technology, which enhances the delivery of cannabidiol (CBD), could potentially offer a new mechanism of action compared to existing treatments, which may provide a competitive advantage in the marketplace.
However, it is important to consider the regulatory environment surrounding CBD-based products. While there is growing interest and acceptance, there is also significant scrutiny. The success of Lexaria's product will depend not only on clinical outcomes but also on navigating the regulatory landscape effectively. As such, the market's response to Lexaria's IND submission will likely be contingent on both the scientific and regulatory progress of DehydraTECH-CBD.
KELOWNA, BC / ACCESSWIRE / January 30, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX; LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces that, on January 29, it submitted its much-anticipated Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for its planned U.S. phase 1b hypertension clinical trial HYPER-H23-1 of DehydraTECH-CBD.
This IND submission follows a successful pre-IND meeting with the FDA which provided Lexaria with guidance related to the development and filing of the IND. From 2018 through 2023, Lexaria sponsored five investigator-initiated human clinical studies of its DehydraTECH-CBD in an aggregate total of 134 people, without recording a single serious adverse event (the "Studies"). These Studies evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens alone and, in some cases, complementary to standard of care medications; suggesting that DehydraTECH-CBD has the potential to have broad therapeutic utility.
As indicated at the FDA website, "once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk."
Lexaria looks forward to commencing clinical trial HYPER-H23-1 as soon as possible following IND effectiveness, subject to certain conditions including funding. The IND review process when successfully concluded will be an important milestone achievement for Lexaria demonstrating that its DehydraTECH technology has met high level formal regulatory scrutiny towards prospective future pharmaceutical commercial registration.
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.
All clinical, laboratory and analysis procedures for study HYPER-H23-1 are to be performed entirely by U.S.-based, third-party independent contract service providers.
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 38 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
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
View the original press release on accesswire.com
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