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Lexaria Bioscience Corp. (NASDAQ: LEXX) Kicks off 2024 with FDA IND Submission for its HYPER-H23-1 Phase 1b Human Clinical Trial

  • Lexaria, a global innovator in drug delivery platforms, just announced the submission of its IND application with the FDA for its HYPER-H23-1 phase 1b hypertension clinical trial
  • This study will seek to evaluate the safety and tolerability of Lexaria’s patented DehydraTECH(TM) technology, specifically DehydraTECH-CBD, in hypertensive patients
  • Lexaria expects to build on success of its previous studies, which showed positive results and DehydraTECH-CBD’s potential to have broad therapeutic utility

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, just announced the submission of its much-anticipated Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for its HYPER-H23-1 phase 1b hypertension clinical trial. The submission follows a successful pre-IND meeting with the FDA, an integral step in the IND’s development and filing (https://cnw.fm/exwpC).

Titled “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,” this study will seek to evaluate the safety and tolerability of Lexaria’s patented DehydraTECH(TM) and specifically DehydraTECH-CBD in hypertensive patients. Secondary objectives will also include efficacy evaluation in reducing blood pressure and detailed pharmacokinetic testing.

The IND submission was initially set for the end of August 2023 but was delayed by the overdue delivery of required analytical and stability information from one of Lexaria’s core ingredient suppliers. However, the company has since made tremendous progress and looks to commence with its HYPER-H23-1 clinical trial as soon as possible following IND effectiveness, subject to certain conditions, including funding.

Lexaria is optimistic about the study and looks to build on the success of its previous studies that date back to 2018. So far, the company has sponsored five investigator-initiated human clinical studies of its DehydraTECH-CBD in an aggregate total of 134 people and has not recorded a single adverse event. Positive results from these studies included significant reductions in resting blood pressure over both acute and multi-week dosing regimens alone and, in some cases, complementary to standard-of-care medications. These results suggested that DehydraTECH-CBD has the potential to have broad therapeutic utility, and that is something Lexaria is looking to explore more in its HYPER-H23-1 clinical study.

This submission affirms Lexaria’s commitment to creating shareholder value. It also points to its goal to fulfill the promises made to its shareholders, as detailed in its roadmap for the 2024 calendar year. For Chris Bunka, Lexaria’s CEO, this marks a significant milestone in line with his pledge to do all he can to “turn 2024 into the year that Lexaria leaps forward.”

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://cnw.fm/LEXX

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