Replies to post #76661 on Biotech Values

[ThomasS]

All-oral cocktails observation: IMO, some folks (not necessarily you) seem to be getting too wrapped up in the concept. The #1 goal remains efficacy; if it requires a cocktail involving an injectable, so be it. In order of relevance for any prospective regime:

1. Efficacy with acceptable SAE profile
2. Efficacy with no SAE's
3. Convenience/compliance
4. Eliminate INF as the injectable component
5. Eliminate the injectable component
6. Eliminate future treatments via vaccine

If adding INF to INFORM resulted in 99% SVR, patients would be all over it.

[DewDiligence]

Re: INFORM-1

I was a little disappointed in the higher dosing groups not appearing to have a greater impact on viral load reduction.

This is a typical outcome in a short-term, dose-escalation study. I don’t see it as a negative at all.

On the plot you posted, it’s notable how the blue line, representing ITMN-191 monotherapy on days 1-3 followed by combo therapy on days 4-7, has a saw-tooth pattern during the monotherapy period that gets smoothed out when combo treatment begins on day 4. In other words, R7128 compensates for the relatively short half-life of ITMN-191 and eliminates the intra-dose troughs.

[DewDiligence]

INFORM-1 HCV Trial Design

INFORM-1 tests the combination of ITMN-191 (a protease inhibitor)
and R7128 (a nucleoside polymerase inhibitor) without either
interferon or ribavirin.

Note that two of the three latter cohorts are in the second-line
setting (for null and non-null responders, respectively, during
first-line treatment).

R7227 is an alternate name for ITMN-191.