- Lexaria’s IND application for its U.S. Phase 1b Hypertension Clinical Study, HYPER-H23-1, remains on track despite setbacks
- Work mostly under Lexaria’s control was completed earlier this year, while work that is outside its control remains delayed
- Regardless, Lexaria continues to make progress, even as it looks to take advantage of the growing global cardiovascular drugs market, which is projected to post a CAGR of 3.1% between 2021 and 2026
- Chris Bunka, Lexaria’s CEO, has lauded the company’s exceptional discovery, which demonstrates the ability of the patented DehydraTECH-processed CBD to lower blood pressure in the patient population
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, remains on track for its upcoming submission of an Investigational New Drug (“IND”) application for its planned U.S. Phase 1b Hypertension Clinical Trial, dubbed HYPER-H23-1. The study, 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,” looks to evaluate the safety and tolerability of Lexaria’s patented DehydraTECH(TM)-processed CBD in hypertensive patients (https://ibn.fm/JTESt).
This study builds on five previous human clinical studies conducted from 2018 to 2022, which will be integral to the successful filing and review of the planned IND submission. Most notably, the studies, which involved 134 healthy and hypertensive persons, evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens. In addition, the studies also showed zero serious adverse events, evidencing DehydraTECH-CBD’s potential to have pronounced clinical benefits relative to available anti-hypertensive therapeutics.
Work that is mainly under Lexaria’s control was completed earlier this year. This included batch manufacturing of DehydraTECH-CBD and placebo materials necessary for the application. However, work outside of Lexaria’s control remains delayed. This includes the provision of required documentation by a materials supplier and stability testing of the material. As such, Lexaria cannot yet submit the IND package to the FDA until the delays have been addressed, although progress is still being made.
In 2021, the global cardiovascular drugs market was estimated at $146.51 billion. By 2026, the market is expected to be valued at $173.48 billion, posting a CAGR of 3.1% (https://ibn.fm/u7ToC). Lexaria looks to capitalize on this growth while carving a decent market share. The IND application with the FDA will be integral to the company realizing this goal and bringing relief to the many people living with cardiovascular conditions.
“That we were able to lower blood pressure in our patient population over multiple weeks using DehydraTECH-CBD is an exceptional discovery, given that previous studies by others using other oral CBD formulations have failed to evidence this sustained benefit,” noted Chris Bunka, Lexaria’s CEO (https://ibn.fm/uiKph).
So far, Lexaria is aware of only a handful of other published research studies that have investigated whether a sustained decrease in resting blood pressure is possible following multiple weeks of oral CBD dosing. However, it notes that none have succeeded in achieving this, proving DehydraTECH-CBD’s superior power to reduce blood pressure over other oral CBD formulations.
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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