Biotech Values

[DewDiligence]

Your comment [to] dewophile about IDX184 efficacy determinations after 3 days stuck in my craw. 3 tiny pills in 72 hours killed enough virus that the liver started to heal in a bunch of people.

I presume you’re referring to the comment in yesterday’s PR that patients in the 75 and 100 mg/day cohorts saw their mean AST and ALT levels decrease from above 1xULT to below 1xULT within the 3-day period. This is impressive, of course; however, efficacy in HCV treatment is defined to terms of the probability of achieving SVR—not in terms of lowering AST and ALT liver enzymes.

Three days of monotherapy testing (not enough to even reach steady-state plasma levels for a drug such as IDX184 with a relatively long half-life) does not tell us much about IDX184’s ability to generate SVR’s in combination therapy, which will depend greatly on IDX184’s showing a lack of additive toxicities with the toxicities of interferon and ribavirin.

How much data (interim 3 day from previous trials) is available?

For drugs that entered clinical trials before the FDA imposed the 3-day limit, the only way to get 3-day data in most cases is to “eyeball” it from a 7-day or 14-day chart, as dewophile did in the case of NM283.

What is the highest dose [IDIX] might try going forward?

IDIX has not yet said what doses will be tested in the phase-2a combination study. My guess is that they will go at least as high as 200mg/day, which is double the level tested in the monotherapy study.