Biotech Values

[frontiers]

ACHN

Your contention is that, from reading the ACH-3422 patent and “other” publicly available sources, you can assert with high confidence that ACH-3422 will have efficacy and safety similar to Sovaldi.

Yes, that is correct!

The data provided by ACHN in the patent application for human hepatocyte cell culture.....27.6 hours for ACH 3422 TP and 22.6 hours for sofosbuvir TP......22% higher for ACH 3422.....hence calculate that Cmax will be higher by 15% on account of the accumulation … if we extrapolate using this to patients..... require a lower dose than sofosbuvir for effectiveness......ACHN testing 300 mg and 500 mg as high end doses vs. 400 mg for sofosbuvir..... My take is that the 300 mg and 500 mg will both be as good as or better than the 4 Log kill that the analysts are requiring. No safety findings, no cardio-renal tox (like INX 189) or liver enzyme elevation (VX 135).

The high potency in in-vitro assays and safety shown in in-vitro assays and animals (rat and dog dosed for 3 months) together with the structure of ACH 3422 supports obtaining high efficacy in the Phase 1 study, safety is a given here. With that said, obtaining results comparable or better than previously tested compounds such as sofosbuvir and VX-135 is to be expected.