Biotech Values

[DewDiligence]

Musings on IDIX NM283 results:

In treatment-naïve patients, the 200mg dose is virtually as effective as the 800mg dose (mean reduction of 3.93 logs and 4.26 logs, respectively, at 12 weeks), and the 200mg dose solves the GI/dropout problem for all practical purposes. That’s the good news, and all this was known to anyone who listened to IDIX’s March 24 CC.

What is less clear, however, is the safety of NM283 at 200mg and 400mg (the latter dose being the one that NVS and IDIX intend to use in treatment-refractory patients). Today’s PR reports three SAE’s in all: 1 of 32 (3.1%) in the 200mg arm (arm B), and 2 of 92 (2.2%) in the pooled 800mg arms (arms C,D,E).

These SAE numbers have been known in rough form since IDIX’s March 24 CC and hence are not news. Moreover, it’s hard to draw much of an inference from such small absolute numbers of SAEs. Certainly, these data do not imply that there is a safety problem with NM283 at low doses. But neither do they rule that out. More data will be needed at 200mg (and 400mg in treatment-refractory patients) to get a truer handle on NM283’s safety profile.