RE: Toxicology studies13 Oct 2024 11:50
Hi Blastoid - is this normal? It really all depends is the short answer. We would have been guided by both the Nucleus Network and whatever studies T&J would have researched prior to starting P1a. The SAD/MAD study used 79 volunteers in a 3:1 ratio so let's assume 19 on placebo and 60 on 1801. Based on what I've read over the last few years, this is a reasonable number for the trial. If we were a large pharma we would possibly have had double those numbers and a longer trial but that costs money we didn't have.
What I'd like to know is if the required additional tox studies will be in humans or not and who has deemed them a requirement. It may be a case of they wouldn't be required if we'd done a P1b study but since we want to jump to P2, that's a larger undertaking and so whichever region (UK/Oz/US) we're looking at to run the P2 study in, the authorities there want more substantial tox data, possibly linked to the black box warnings on earlier inhibitors.