LEXXW - Lexaria Provides Update on Investigational New Drug Application Progress
(TheNewswire)
Kelowna, British Columbia - TheNewswire - August 30, 2023 - Lexaria BioscienceCorp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the “ Company ” or“ Lexaria ”), a global innovator in drug delivery platforms, isproviding this update on the status of the Company’s anticipatedsubmission of an Investigational New Drug (“IND”) application withthe U.S. Food and Drug Administration (“FDA”) for its planned U.S.Phase 1b Hypertension Clinical Trial designated as HYPER-H23-1.
As previously reported, work that was mostly underLexaria’s control such as batch manufacturingof DehydraTECH™-processed cannabidiol and placebo materialsnecessary for the IND application filing was completed earlier thisyear, followed by analytical release and ongoing stability testing.
In parallel, compilation of the large set ofdocumentation necessary for inclusion in the IND filing has beenprogressing on time by the Company and its service providers. However, work that is outside of Lexaria’s control, namely theprovision of required documentation by one of Lexaria’s materialsuppliers related to their analytical and stability testing of theirmaterial, has been delayed. Accordingly, Lexaria is not in a positionto submit the IND package to the FDA for their review andconsideration until these delays have been cured by the supplier.
Lexaria is in communication with its material supplierto provide their required information as soon as possible but, as atthe current date, we have not received the results nor an estimatedtime of receipt for same. Lexaria continues to finalize the INDapplication so that the Company is in a position to file with the FDAas soon as possible following receipt of the outstanding informationand will provide updated details regarding the status of its INDapplication filing as they become available.
Background and Medical/MarketRationale
Lexaria’s five previous human clinical studies ofDehydraTECH-CBD in hypertension conducted from 2018 through 2022,which were not conducted under FDA-registration but are integral tosuccessful filing and review of its planned IND submission, werecarried out in an aggregate total of 134 healthy and hypertensivepersons. These foundational studies evidenced significant reductionsin resting blood pressure over both acute and multi-week dosingregimens, and also produced zero serious adverse events; suggestingthat DehydraTECH-CBD has the potential to have pronounced clinicalbenefits relative to available anti-hypertensive therapeutics.
Lexaria is aware of only a handful of otherpublished research studies , mostly in young,healthy and normotensive volunteers, that have investigated whether asustained decrease in resting blood pressure is possible followingmultiple weeks of oral CBD dosing; none of which have been successfulin achieving this. DehydraTECH-CBD is currently unique in itsevidenced superior power to reduce blood pressure over other oral CBDformulations.
Findings from Lexaria’s latest study HYPER-H21-4 demonstrated a potentially novelmechanism of action of DehydraTECH-CBD inreducing blood pressure which may be explained,at least in part, by its interaction with the humansympatho-chromaffin system via catestatin modulation as detailed inthe peer-reviewed and published respected journal, " Biomedicine andPharmacotherapy ". This is significant because the FDA haspreviously laid out clear guidelines forsponsors who seek to develop newanti-hypertensive drugs, specifically defining the need formedications 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 reductionbenefits on top of any degree ofimprovements that standard of care medications achieved for patientsprior to DehydraTECH-CBD dosing.
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 DehydraTECH
DehydraTECH is a patented drug delivery formulation andprocessing platform technology Lexaria has developed and isinvestigating for a variety of beneficial molecules. DehydraTECH isdesigned to improve the way active molecules enter the bloodstreamupon oral ingestion. DehydraTECH has also demonstrated enhanceddelivery of certain active molecules into brain tissue, which Lexariabelieves to be of particular importance for centrally activecompounds. Lexaria has also developed DehydraTECH formulations forother applications demonstrating superior bio-absorption whenadministered intraorally and topically.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.’s patented drug deliverytechnology, DehydraTECH™, improves the way active pharmaceuticalingredients (APIs) enter the bloodstream through oral delivery. Since2016, DehydraTECH has repeatedly demonstrated the ability to increasebio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors andmore. DehydraTECH has also evidenced an ability to deliver some drugsmore effectively across the blood brain barrier. Lexaria operates alicensed in-house research laboratory and holds a robust intellectualproperty portfolio with 35 patents granted and many patents pendingworldwide. For more 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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