It’s curious that the first CVR payout is triggered by enrollment of the fifth patient in the BLU-808 phase-2b/phase-3 trial. This gives SNY an opening to enroll three or four patients and then halt the trial for (alleged) safety reasons.
THRD's first drug got into liver tox issues only after 8 weeks or so of dosing. There was zero signal in the HV trial (I think it went 2 weeks). They claim this was due to accumulation of a toxic metabolite. So it was halted after like 3-4 patients were dosed. So this might explain this odd trigger for the CVR. FWIW THRD made a point of saying their follow on drug doesn't have this issue preclinically, as has ENTA
No GSH adducts (or reactive metabolites) detected in vitro or in vivo
It’s curious that the first CVR payout is triggered by enrollment of the fifth patient in the BLU-808 phase-2b/phase-3 trial. This gives SNY an opening to enroll three or four patients and then halt the trial for (alleged) safety reasons.
I still can't explain why the fifth patient specifically triggers one of the payouts, but in addition to my previous response I did find the BLU-808 AAAAI abstract. The two higher doses tested in the MAD cohort had a 1.9 and 2 point reduction in hemoglobin vs a 1 point reduction for all other doses and placebo. This is worse than CLDX which had an equivalent of 2 point reduction in phase 1 only at the highest dose arm , and that dose is now dropped from further development. All other doses for CLDX had comparable drops to PBO, and the middle doses were plenty to get to high tryptase reductions versus BLU-808 which only got there at the two highest doses So the BPMC data is not as clean as they make it out to be IMO. I don't think this was lost on SNY from the structure of the deal