Replies to post #66936 on Biotech Values

[iwfal]

ZGEN - It looks like the drug is on target to reach the market around the time when interferon therapies will be starting to become less relevant.

I asked a related question several months ago - are there any drugs seeking approval via a clinical program without IFN? Your answer at the time was no. Obviously there are the earliest possible signs that that is changing - but so far I've only seen one trial aimed at a no IFN treatment (albeit I haven't done a thorough scan through clinical trials.org)

Some more related questions (if you have info, great. If not it is something I need to look into):

1) As standalone agents how well do some of the candidates for a drug cocktail work? (This goes to whether there is a chance that they are so much better that they will make IFN obsolete)

2) SAEs for the drugs in trials - so far it appears that ribvarin(sp?) has more SAEs than IFN-L

PS I am not sure I would call it the 'slow lane'. Actually reasonably fast at this point - e.g. they started the ribivarin portion of the trial early (although I'll agree they were not terribly speedy up until the start of the phase ib). The question is whether that is fast enough.

[dewophile]

I for one think its hard to bet against either ribavirin (which has already proven critical to SVR when dropped from the regimen - I'm sure you remember that well) or IN. both not only suppress VL, but are felt to participate in reprogramming the immune system to enable a durable response once antiviral therapy is discontinued. none of the direct antivirals do this. so the question is will just ribavirin - a more toxic agent than IN - be able to work its magic (to quote JP) on the immune system just as well without interferon?
besides - interferon lambda is likely to have less SEs than many of the direct antivirals (telaprevir - horrendous rash, polymerase inhibitors - GI tolerance issues), so the impetus to drop traditional INs from regimens because of their toxicity may simply not be there if IN lambda's profile meets expectations. in fact, In lambda may be among the easiest anti-HCV drugs to take - despite the fact it is an injection - when all is said and done.

PS: we'll soon see if pharma agrees with you based on the type (if any) partnership zgen can negotiate for the drug

PPS: I think the biggest threat to interferons was actually negated when the anadys oral TLR drug aimed at boosting endogenous IN failed preclinicals