Replies to post #147081 on Biotech Values

[mcbio]

The graveyard related to safety issues - I don't think it matters that this is a different indication than for the previous drugs. The safety issues have been all over the place - hard to know if they are class effects or (perhaps more likely) because most of the molecules were built off the same scaffold if I recall correctly.

I will respectfully disagree. The article you linked to referenced the failure of p38 inhibitors in RA. RA is in no way an unmet medical need. There are plenty of effective treatments for RA. I don't see that as being the case for pain patients resistant to NSAIDs and who don't tolerate opioids. So, point is the safety bar is lower for an indication with an unmet need compared to those where there are plenty of effective treatments.

[jq1234]

I disagree about longer term treatment being more effective, I think it is just opposite. The significant but transient decrease of CRP meant the effect of inhibition of p38 alone is short lived, which is why the article talked about biologic adaptations of escape from this pathway. So to me, in addition to safety concern, either find escape pathway for potential combination treatment for longer term use, or this class of drug is only effective for very short term use.

[mcbio]

The safety issues have been all over the place - hard to know if they are class effects or (perhaps more likely) because most of the molecules were built off the same scaffold if I recall correctly.

This probably doesn't advance the discussion much, but, per its 10-K filed today, ARRY disclosed:

"Compared to other p38 inhibitors, ARRY-797 has distinct properties: it is highly selective, has exceptional potency in whole blood samples, has a differentiated pharmacokinetic profile and is highly water soluble."