LEXXW - Lexaria Unveils Extensive Planned 2024 GLP-1 Study Program
(TheNewswire)
Extensive work program designed tosupport commercial discussions.
Kelowna, British Columbia – TheNewswire - January 16, 2024 –Lexaria Bioscience Corp. (Nasdaq:LEXX )(Nasdaq: LEXXW) (the “Company” or“Lexaria”), a global innovator in drug delivery platformsannounces a comprehensive planned applied research program tothoroughly evaluate DehydraTECH for the improved delivery of GLP-1drugs, designed to support prospective commercial partnering with theglobal pharmaceutical companies.
In a recent human pilotstudy with 7 volunteers, Lexariademonstrated superior pharmacokinetic (“PK”) oral deliveryperformance of the DehydraTECH-enhanced glucagon-like peptide-1(“ GLP-1 ”) drug semaglutide available commercially in the brandedproduct Rybelsus®. The results were sufficiently positive toencourage much more thorough and expanded investigation.
The objective of the new planned studies is to helpdetermine the commercial applicability of DehydraTECH to at leastthree GLP-1 drugs (semaglutide, liraglutide, and tirzepatide) whichtogether produced billions of dollars of revenue to their owners, asreported in their most recent financial statements. The new plannedstudies to be undertaken are as follows:
Chronic Dosing Animal Study
Targeted start March/April, 2024. This will be an obeserat diabetic-conditioned study similar to a previous Lexaria study , with approximately 12 study arms and 6-10 animals per arm.The study is expected to run for 12 weeks to allow time to studyweight loss, PK, and blood sugar control over time, followed by fulldata analysis and reporting. Varied DehydraTECH formulations ofsemaglutide and liraglutide, alone and together with DehydraTECH-CBD,will be evaluated. We also expect to be evaluatingDehydraTECH-processed semaglutide with and without thesalcaprozate sodium “SNAC” technology currently found withinRybelsus ® tablets. Wewill be collecting and reporting interim results prior to the end ofthe study.
Human Pilot Study #2
Targeted start March/April, 2024. This human pilotstudy in up to 8 healthy volunteers, will study a single dose of oralingested DehydraTECH-semaglutide capsules in a similar design to Human Pilot Study #1 . We also intend to study an oral dissolvableDehydraTECH-semaglutide tablet formulation (dissolvable intosublingual/buccal tissue) to determine whether GLP-1 drug absorptionvia this route is effective and well tolerated as an alternative tothe conventional oral ingestible route which often presents withgastrointestinal side effect issues. Tolerability, PK, and bloodsugar control will all be evaluated. The DehydraTECH compositionsfor this study will be compound-formulated using commerciallyavailable Rybelsus tablets as the semaglutide input material.
Human Pilot Study #3
Targeted start in May/June, 2024. This human pilotstudy in up to 8 healthy human volunteers will study a single dose oforal ingested DehydraTECH-tirzepatide capsules (to becompound- formulated using Zepbound ® byEli Lilly) to evaluate tolerability, PK, and blood sugar.Zepbound ® is currentlyadministered by injection only and will be used as the tirzepatideinput material for production of the DehydraTECH-tirzepatide capsulesto be studied. Importantly, this study will evaluate DehydraTECHeffectiveness in humans with a dual action GLP-1 + glucose-dependentinsulintropic peptide (aka “GIP”) drug while also doing so withoutthe SNAC ingredient found in the Rybelsus ® semaglutide composition from HumanPilot Studies 1 and 2.
Chronic Dosing Human Study
Targeted start Q3, 2024. This chronic human study in70 to 90 pre-diabetic and type-2 diabetic human patients will dosedaily using oral DehydraTECH capsules for 12 weeks and will evaluatetolerability, PK, weight loss, blood sugar levels and more. Theprimary goal of this study will be to compare DehydraTECH-processedsemaglutide capsules (from compound-formulated Rybelsus ® tablets as the semaglutide inputmaterial) to DehydraTECH-CBD capsules alone - and together incombination - relative to a placebo control over an extended period oftime. Inclusion of DehydraTECH-CBD in this study will be undertaken todetermine if the improvements in glycemic control and weight losswitnessed in Lexaria’s previous animal study are evidenced inhumans.
Long Term Stability Testing
Lexaria plans to study the chemical and microbiologicalpurity and stability of select DehydraTECH compositions that itprepares for the above planned upcoming animal and human studies overan extended duration of 6-12 months. Along with improved tolerability,PK and efficacy performance, long term stability is crucial if oralvariants of GLP-1 drugs are to be seriously considered as replacementsfor currently injectable versions of these drugs.
All the programs described above are subject to changeor substitution; dates are targets only; and some are subject toraising sufficient funds. All human studies will beinvestigator-initiated non-registrational studies and will requirecertain approvals before beginning. All studies will utilizethird-party laboratories.
Lexaria is excited to be embarking on this expandedGLP-1 investigatory program at a time that there is a clear medicaland market need for improved performance and broader oral delivery ofthis class of drugs. Lexaria will continue to provide furtherupdates on this GLP-1 study program as it progresses and more detailsbecome available.
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 38 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 to 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.
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