Post by
prophetoffactz on Apr 29, 2024 9:55am
Avenanthramide
It looks like they want to move forward with a 240mg avenanthramide pill administered twice per day and as a single dose CZO has already cleared the 480mg dose level without adverse event. Has CZO therefore likely de-risked the safety risk of the pill; especially given the historic safety/tolerability profile of avenanthramide in humans? That would only leave efficacy risk and a significant amount of human data already exists considering efficacy in humans.
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News release:
In planning for the extension into a Phase 2a clinical study, a second GMP clinical batch of the selected 30mg and 240mg pill formulation of the drug product was manufactured by Corealis Inc. GMP Manufacturing Services (“Corealis”). Stability studies are ongoing.
Significantly advanced Phase 1 safety and tolerability study with healthy volunteers at Montreal Heart Institute (MHI). Since commencing the dosing of first patients in December 2023, five groups of 8 subjects per group have completed the first arm of the Phase 1 with single ascending doses (SAD) ranging from 30mg to 480mg per day. A Data Safety Monitoring Board is to decide shortly regarding the administration of the highest dose (960mg) as per approved protocol by Health Canada. As no significant adverse reactions have been observed so far, the Company expects to initiate the multiple ascending dose (MAD) arm during the summer 2024 with three additional groups of 8 subjects per group. This is the first-in-human clinical study to assess safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of avenanthramides.