The current market activity surrounding Lexaria Bioscience Corp. (NASDAQ: LEXX) underscores a notable upsurge in its stock performance on the US market today. At the latest check during the current trading session, Lexaria’s stock exhibited a marked increase of 22.63%, reaching a trading value of $2.33. Although this surge in LEXX stock occurred in the absence of immediate news, recent developments shed light on the factors influencing its market behavior.
Notably, on January 29, Lexaria (LEXX) disclosed that company has finally submitted an Investigational New Drug (“IND”) application to the Food and Drug Administration (“FDA”). This application relates to its planned phase 1b clinical research, HYPER-H23-1, in the United States, which uses DehydraTECH-CBD to treat hypertension.
This IND submission followed a productive pre-IND meeting with the FDA, during which Lexaria received valuable guidance regarding the development and filing processes associated with the IND. Noteworthy is the fact that from 2018 through 2023, Lexaria sponsored five investigator-initiated human clinical studies evaluating DehydraTECH-CBD, encompassing a total of 134 participants.
Importantly, these studies yielded promising results, showcasing significant reductions in resting blood pressure across various dosing regimens, both independently and, in certain instances, in conjunction with standard of care medications. Such findings underscore the potential broad therapeutic applications of DehydraTECH-CBD.
Per the FDA’s protocol, once an IND is submitted, a mandatory 30-day waiting period ensues before any clinical trials can commence. This interval allows the FDA to meticulously review the submitted IND to ensure the safety of research subjects and mitigate any potential risks.
Lexaria is currently directing its efforts towards the expeditious initiation of clinical trial HYPER-H23-1 post-IND approval, contingent upon various factors, including securing adequate funding. The successful conclusion of the IND review process will represent a significant milestone for Lexaria, affirming the rigorous regulatory scrutiny applied to its DehydraTECH technology in the context of prospective pharmaceutical commercial registration.
