- Dosing for Lexaria’s ambitious and most comprehensive clinical study, HYPER-H21-4, was successfully completed in July 2022, with newly analyzed results now emerging
- Its latest findings bring the company closer to its upcoming FDA Phase 1b study while also explaining the patented DehydraTECH-(TM)-processed CBD interaction with the sympatho-chromaffin system via catestatin modulation
- Lexaria’s management is optimistic that DehyraTECH-CBD and its effectiveness in modulating catestatin levels could become a significant value enhancer should it eventually enter the marketplace as an approved hypertension treatment
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, kicked off its human clinical study, HYPER-H21-1 in 2021, focused on testing its patented DehydraTECH(TM)-processed cannabidiol (“CBD”) for the potential use as a hypertension treatment alternative (https://cnw.fm/4sQYN). On July 27, 2022, the company announced that the dosing for its HYPER-H21-4 multi-week human clinical study was successfully completed, with no serious adverse events resulting from the dosing (https://cnw.fm/imOSQ).
This safety-related outcome – no serious adverse events – is generally speaking the desired primary outcome of Lexaria’s upcoming Phase 1b FDA-registered study.
Designed to enhance Lexaria’s probability of success toward an Investigational New Drug (“IND”) application filing for the U.S. Food and Drug Administration (“FDA”) approval, HYPER-H21-4 was the most comprehensive clinical study ever undertaken by Lexaria, with many types of analysis performed. Its latest findings from the study take things a step further while also explaining DehydraTECH-CBD’s interaction with the sympatho-chromaffin system via catestatin modulation.
In addition, the findings have been published in the respected peer-reviewed journal, “Biomedicine and Pharmacotherapy.” The company is aware of only a handful of other published research studies that have investigated whether a sustained decrease in resting blood pressure (“BP”) is possible following multiple weeks of oral CBD dosing, none of which have been successful in achieving this (https://cnw.fm/hvWYO).
The findings showed that DehydraTECH-CBD resulted in a statistically significant reduction in average baseline serum catestatin concentrations of 13.50 ng/mL to just 9.65 ng/mL after five weeks of dosing, representing a 28.5% drop. In addition, mean arterial pressure significantly dropped by 4.26 ± 1.26 mm/Hg following the five weeks of DehydraTECH-CBD dosing. No statistically significant reductions in catestatin concentrations were identified in the placebo group.
Given the growing demand for alternative anti-hypertensive treatments and therapies, Lexaria recognizes an opportunity and seeks to fill it. These latest results from its ambitious HYPER-H21-4 study inch the company closer to achieving that goal, ultimately becoming a leader and tapping into a pharmaceutical market that is set to be valued at $34 billion by 2030. Lexaria’s management is optimistic that DehydraTECH-CBD and its effectiveness in modulating catestatin levels could become a significant value enhancer should it eventually enter the marketplace as an approved hypertension treatment.
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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