LEXXW - Lexaria Announces Positive Feedback from Pre-IND Meeting with FDA on DehydraTECH-CBD for Hypertension
(TheNewswire)
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Significant Milestone Achieved inCommercial Product Development Program
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Abbreviated 505(b)(2) StrategyConfirmed as an Appropriate NDA Pathway
Kelowna, British Columbia – TheNewswire - August 10, 2022 – Lexaria BioscienceCorp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the“Company” or “Lexaria”), a global innovator in drug deliveryplatforms is pleased to announce that it has received a positive fullwritten response from the Food and Drug Administration (“FDA”)from its pre-Investigational New Drug (“Pre-IND”) meetingregarding DehydraTECH-CBD for the treatment of hypertension.
The FDA confirmed that it agreed with Lexaria’sproposal to pursue a 505(b)(2) new drugapplication (“NDA”) regulatorypathway for its program which is advantageous because this abbreviated pathway, as it is often described, typically enables afaster route to commercial approval than the traditional 505(b)(1) NDApathway.
Lexaria’s proposed Phase Ib clinical protocol forDehydraTECH-CBD for treatment of a target of 100 patients withhypertension was received favorably by the FDA, with a view to openingthe IND application to allow Lexaria to work towards full registrationof DehydraTECH-CBD for treatment of hypertension.
“We are very pleased to have received comments fromthe FDA toward opening our IND program and we will be executingFDA-confirmed IND-enabling work immediately,” said John Docherty,President of Lexaria Bioscience Corp. “We were delighted that ourproposals were very well received by the FDA and the feedback receivedwill be very helpful in compiling and filing our IND application asthe next major regulatory step we are focused on movingforward.”
Additionally, as part of the communication with FDA, itagreed that additional non-clinical studies are not required prior toinitiation of the DehydraTECH-CBD IND program, given the compellingdata already presented by Lexaria and others regarding the safety andtolerability of CBD. This supports Lexaria’s long-held belief thatits recent human clinical study program would be supportive of oureventual FDA registration pursuits.
As a result of the favorable FDA response, Lexariaexpects to remain on track to file its full IND application with theFDA by late 2022 / early 2023 as previously announced. This is up to6-9 months sooner than if the FDA had required modifications inLexaria’s current IND-enabling work plan, such as performance ofadditional non-clinical study work.
DehydraTECH-CBD is protected by multiple patents in theUSA and internationally and has received specific patent protection inboth the EU and Australia for use in the treatment of heart disease.Lexaria continues to investigate all opportunities within the heartdisease sector, including hypertension, arterial stiffness, and more.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.’s patented drug deliverytechnology, DehydraTECH™, improves the way active pharmaceuticalingredients (APIs) enter the bloodstream by promoting more effectiveoral delivery. Since 2016, DehydraTECH has repeatedly demonstrated theability to increase bio-absorption with cannabinoids, antiviral drugs,PDE5 inhibitors and more. DehydraTECH has also evidenced an ability todeliver some drugs more effectively across the blood brain barrier.Lexaria operates a licensed in-house research laboratory and holds arobust intellectual property portfolio with 26patents granted and roughly 50 patents pending worldwide. For moreinformation, 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. 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 contained herein, whether as aresult of any new information, future events, changed circumstances orotherwise, except as otherwise required by law.
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