LEXXW - Lexaria Submits Investigational New Drug Application
(TheNewswire)
Kelowna, British Columbia – TheNewswire -- January 30, 2024 –Lexaria Bioscience Corp. (Nasdaq:LEXX )(Nasdaq: LEXXW) (the “Company” or“Lexaria”), a global innovator in drug delivery platforms,announces that, on January 29, it submitted its much-anticipatedInvestigational New Drug (“IND”) application with the U.S. Foodand Drug Administration (“FDA”) for its planned U.S. phase 1bhypertension clinical trial HYPER-H23-1 of DehydraTECH-CBD.
This IND submission follows a successful pre-INDmeeting with the FDA which providedLexaria with guidance related to the development and filing of theIND. From 2018 through 2023, Lexaria sponsored fiveinvestigator-initiated human clinical studies of its DehydraTECH-CBDin an aggregate total of 134 people, without recording a singleserious adverse event (the “Studies”). These Studies evidenced significant reductions in restingblood pressure over both acute and multi-week dosing regimens aloneand, in some cases, complementary to standard of care medications;suggesting that DehydraTECH-CBD has the potential to have broadtherapeutic utility.
As indicated at the FDAwebsite , “ once the IND is submitted, the sponsor must wait 30 calendardays before initiating any clinical trials. During this time,FDA has an opportunity to review the IND for safety to assure thatresearch subjects will not be subjected to unreasonable risk.”
Lexaria looks forward to commencing clinical trialHYPER-H23-1 as soon as possible following IND effectiveness, subjectto certain conditions including funding. The IND review process whensuccessfully concluded will be an important milestone achievement forLexaria demonstrating that its DehydraTECH technology has met highlevel formal regulatory scrutiny towards prospective futurepharmaceutical commercial registration.
About Planned Clinical TrialHYPER-H23-1
Clinical trial HYPER-H23-1 is entitled ‘ A Phase 1b Randomized, Double-Blind,Placebo-Controlled Study of the Safety, Pharmacokinetics, andPharmacodynamics of DehydraTECH-CBD in Subjects with Stage 1 or Stage2 Hypertension’ . The primary objective ofthe trial will be to evaluate safety and tolerability in hypertensivepatients, and secondary objectives will include efficacy evaluation inreducing blood pressure together with detailed pharmacokinetictesting.
All clinical, laboratory and analysis procedures forstudy 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 deliveryformulation and processing platform technology which improves the wayactive pharmaceutical ingredients (APIs) enter the bloodstream throughoral delivery. Since 2016, Lexaria has developed and investigatedDehydraTECH with a variety of beneficial molecules in oral and topicalformats. DehydraTECH has repeatedly demonstrated the ability toincrease bio-absorption and has also evidenced an ability to deliversome drugs more effectively across the blood brain barrier, whichLexaria believes to be of particular importance for centrally activecompounds. Lexaria operates a licensed in-house research laboratoryand holds a robust intellectual property portfolio with 38 patentsgranted and many patents pending worldwide. Formore information, please visit www.lexariabioscience.com .
CAUTION REGARDING FORWARD-LOOKINGSTATEMENTS
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 arenot limited to, statements by the Company relating the Company’sability to carry out research initiatives, receive regulatoryapprovals or grants or experience positive effects or results from anyresearch or study. Such forward-looking statements are estimatesreflecting the Company's best judgment based upon current informationand involve a number of risks and uncertainties, and there can be noassurance that the Company will actually achieve the plans,intentions, or expectations disclosed in these forward-lookingstatements. As such, you should not place undue reliance on theseforward-looking statements. Factors which could cause actual resultsto differ materially from those estimated by the Company include, butare not limited to, government regulation and regulatory approvals,managing and maintaining growth, the effect of adverse publicity,litigation, competition, scientific discovery, the patent applicationand approval process, potential adverse effects arising from thetesting or use of products utilizing the DehydraTECH technology, theCompany’s ability to maintain existing collaborations and realizethe benefits thereof, delays or cancellations of planned R&D thatcould occur related to pandemics or for other reasons, and otherfactors which may be identified from time to time in the Company'spublic announcements and periodic filings with the US Securities andExchange Commission on EDGAR. The Company provides links tothird-party websites only as a courtesy to readers and disclaims anyresponsibility for the thoroughness, accuracy or timeliness ofinformation at third-party websites. There is no assurance that any ofLexaria’s postulated uses, benefits, or advantages for the patentedand patent-pending technology will in fact be realized in any manneror in any part. No statement herein has been evaluated by the Food andDrug Administration (FDA). Lexaria-associated products are notintended to diagnose, treat, cure or prevent any disease. Anyforward-looking statements contained in this release speak only as ofthe date hereof, and the Company expressly disclaims any obligation toupdate any forward-looking statements or links to third-party websitescontained herein, whether as a result of any new information, futureevents, changed circumstances or otherwise, except as otherwiserequired by law.
INVESTOR CONTACT:
George Jurcic - Head of InvestorRelations
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