Replies to post #84244 on Biotech Values

[DewDiligence]

ACHN re: ACH-1625 phase-1a results

Dew (or others): the PR noted that there were no SAEs in the Phase 1a trial and that adverse events were "mild and transient." I am just curious if it's normal to see adverse events of any kind in a Phase 1a trial for an HCV PI in healthy patients.

Inasmuch as the phase-1a portion of the study tested subjects for only 5 days, I think it’s too early to say that ACH-1625 will have a clean safety profile.

The dose tested in the Phase 1a went up to 2000 mg/day, which I assume is well above what will be tested in HCV patients in the Phase 1b given the potency of ACH-1625.

That’s unclear, IMO. ACHN appears to be playing its cards close to the vest; however, it’s worth noting that the cumulative daily doses of Telaprevir and Boceprevir being tested in phase-3 are 2250mg and 2400mg, respectively.

[genisi]

I am just curious if it's normal to see adverse events of any kind in a Phase 1a trial for an HCV PI in healthy patients

You don't want to see clinically significant lab abnormalities or that the drug has a clinically significant effect on vital signs, QTc or ECG parameters. You can see AE in a phase 1a trial like in the case of ANA598, where 3 of 24 subjects dosed with ANA598 discontinued therapy due to grade 2 rash in the a healthy volunteer study (it was a 14 day study though).