Biotech Values

[mcbio]

Re: ANDS trial design

ANDS - Base on the initial trial design, the 30 patients receiving placebo were divided into two groups of 15 at 200 mg and 400 mg. The EASL results PR states "Approximately 90 patients have been enrolled in this
study – with approximately 30 patients receiving ANA598 plus SOC at each dose level and 30
patients receiving placebo plus SOC" while the PR when the patients were dosed last year stated "Ninety patients are planned to be enrolled in this study - thirty patients receiving ANA598 and fifteen
receiving placebo at each dose level."

I don't recall a change in the trial design since the original PR so it appears that they've conveniently changed how they are going to calculate placebo response to mask the unusually high placebo response.

It seems to me that the results for each dose level should compare 30 patients on the drug vs 15 on placebo and not the entire 30 on placebo or am i nitpicking.

Perhaps I misread, but it sounds to me like the trial design has not changed from how it was originally envisioned. I.e., it still sounds like ANDS is comparing ANA598 to placebo at a 2:1 ratio at each dose level. I think your first set of bolded text reads as 30 patients receiving placebo plus SOC total, which would mean 15 placebo patients across the two dosing groups. Since the study is 90 patients total and the text prior to the first set of bolded text reads 30 patients receiving ANA598 plus SOC at each dose level, that would equate to 60 patients total receiving ANA598 plus SOC and would leave 30 patients total to receive placebo. That would obviously be split between the two dosing groups for 15 placebo patients at each dose level. So, I don't think anything has changed.

Regardless, I don't take ANDS too seriously as an investment opportunity. The company is effectively down to one HCV shot on goal and that one drug has already shown some safety issues. How someone could consider ANDS over, say, ACHN when both are in the same valuation ballpark but ACHN has a lead HCV PI that has shown no issues so far in the clinic and when ACHN has a strong backup PI and other drugs is beyond me.