Replies to post #147091 on Biotech Values

[mcbio]

Read the article again, looking at all the safety issues that were mentioned. Any of those would be enough to kill the drug in this indication too.

Specifically, looks like pamapimod had 21% withdrawal rate from its 12-week RA study due to AEs and AEs included infection, skin disorders, elevated liver enzymes, GI disorders, and RA rash. For doramapimod, the drug was tested in RA, Crohn's, and psoriasis in 4-week and 8-week studies and the drug was ultimately dropped due to liver abnormalities. VX-745 was halted due to neurologic problems in animals (FWIW ARRY also said in the CC today they have 6-month and 9-month tox data in animals with 797 with no apparent issues). Scio-469 also had liver enzyme abnormalities in its 12-week RA trial. AMG-458 had liver enzyme elevations in its 14-day study.

All told, liver issues seems to be the common AE issue out to 12 weeks. That didn't seem to be an issue for 797 here in the just reported 28-day study given patient withdrawal rate due to AEs for 797 arm was actually less than placebo (6% vs 8%). It would be interesting to see detailed safety data from that AS trial testing out to 85 days. I don't have that off-hand.