Replies to post #95642 on Biotech Values

[mcbio]

Re: ACHN-addendum re ACH-1625 data

Addendum re ACH-1625 data in #msg-50044485: It’s curious that the control arms in all four cohorts showed a reduction in viral load of 0.22-0.29 logs* after five days of “dosing” with nothing but a sugar pill. Insofar as VL measurements are empirical rather than subjective, I find it surprising that all four cohorts showed a placebo benefit and that the placebo VL reductions fell within a tight range.

Perhaps ANDS can license the sugar pill and declare it has a robust HCV pipeline?

In all seriousness, you're not suggesting that the control arm response should lead one to view the ACH-1625 data suspiciously are you? I assume not, but just want to confirm.

[turtlepower]

ACHN - Actually the last two cohorts showed an increase in viral load. The first two did show a decrease.

Subjects in the third cohort of HCV-infected patients received doses of 200mg twice-daily (n=9, randomized to 6 active drug, 3 placebo) for five days. Preliminary results showed that a mean maximum reduction in viral load of 3.86 log10 was achieved in the treatment group, as compared to a mean rise of 0.16 log10 in the placebo group. All subjects in the treatment group had viral load decline greater than 3.0 log10. Mean alanine aminotransferase (ALT) levels decreased over the treatment period and continued to show decline at day 12. Safety results from this dosing group were similar to those observed in previous segments of the trial. There were no serious adverse events, and no clinically significant changes in vital signs, electrocardiograms or laboratory evaluations. All reported adverse events in patients receiving ACH-1625 were classified as mild or moderate and were transient. As seen in previous dosing cohorts, sustained viral suppression was noted with patients maintaining a mean reduction of 1.65 log10 from baseline through day 12, seven days after dosing was completed and the last day of viral load measurement in the study.

Fourth Dosing Cohort Results (600mg Once Daily)

Subjects in the fourth cohort of HCV-infected patients received doses of 600mg once-daily (n=8, randomized to 6 active drug, 2 placebo) for five days. Preliminary results showed that a mean maximum reduction in viral load of 3.81 log10 was achieved in the treatment group, as compared to a mean rise of 0.24 log10 in the placebo group. All subjects in the treatment group had viral load decline greater than 3.0 log10. Mean alanine aminotransferase (ALT) levels decreased over the treatment period and continued to show decline at day 12. Safety results from this dosing group were similar to those observed in previous segments of the trial. There was one non-drug-related serious adverse event, a bone fracture in a patient receiving placebo. There were no clinically significant changes in vital signs, electrocardiograms or laboratory evaluations. All reported adverse events in patients receiving ACH-1625 were classified as mild or moderate and were transient. Again, sustained viral suppression was noted in this dosing cohort of HCV-infected subjects, with patients maintaining a mean reduction of 2.19 log10 from baseline through day 12, seven days after dosing was completed and the last day of viral load measurement in the study.