Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, is improving how active pharmaceutical ingredients (“APIs”) enter the bloodstream by promoting healthier oral ingestion methods and increasing the effectiveness of fat-soluble active molecules through its patented DehydraTECH(TM) technology. DehydraTECH can be used with a wide range of product formats, including pharmaceuticals, neutraceuticals, consumer packaged goods, and over-the-counter pills, capsules, tablets, and oral suspensions.
Lexaria is focusing its ongoing research and development efforts on advancing product candidates across several key segments, including nicotine replacement, cannabidiol (“CBD”) for hypertension, diabetes and epilepsy, antivirals, human hormones, and phosphodiesterase type 5 (“PDE5”) inhibitors.
The company recently announced the completion of its diabetes animal study DIAB-A22-1, with at least three positive outcomes, including weight loss in obese diabetic-conditioned animals, with improved triglycerides and cholesterol levels. Lexaria plans to conduct additional investigations to learn what an optimum DehydraTECH-CBD dose related to both weight loss and increased physical activity might be, considering that the higher dose studied may have created sedative-like effects of CBD triggering hypolocomotion, which has been observed upon high systemic exposure (https://ibn.fm/zCd08).
Separately, Lexaria has also announced that California-based InClin, Inc. has been awarded the contract for clinical research organization (“CRO”) services for the expected upcoming Food and Drug Administration (“FDA”)-registered, U.S. Phase 1b Investigational New Drug (“IND”) hypertension study HYPER-H23-1 with its DehydraTECH-CBD.
The study 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 this study will be to evaluate the safety and tolerability in up to 120 hypertensive patients, with secondary objectives of efficacy evaluation in reducing blood pressure and detailed pharmacokinetic testing.
InClin is preparing for the study start-up, and Lexaria is expected to begin with patient dosing as soon as possible after the FDA IND filing and review are complete. The company anticipates filing the IND this summer, with FDA authorization likely to follow within about 60 days – resulting in Phase 1b trial commencement of patient dosing as early as October 2023.
According to a recent press release, InClin’s study start-up services include, but are not limited to, clinical site evaluation and selection, personnel and site training, project management, clinical database design and management, quality assurance support, medical writing, study documentation creation, biostatistics and programming, support vendor coordination, Independent Review Board submissions and more (https://ibn.fm/KqAAL).
At the end of April, Lexaria announced that it had received notification of being awarded or allowed four new patents, bringing the total up to 32 granted or allowed patents and even more pending worldwide. The new patents include the United States, Japan, Australia, and Canada. The patent in the U.S. will be the first for Patent Family #21: Compositions and Methods of Treating Hypertension, which the company believes will be particularly important related to its pursuit of utilizing DehydraTECH-CBD concerning the company’s upcoming FDA IND application (https://ibn.fm/XYAPO).
For more information, visit the company’s website at www.LexariaBioscience.com.
NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://ibn.fm/LEXX
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