Replies to post #27852 on Biotech Values

[kcalt]

<In the 200 mg/day arm (arm B*; n=31), 87 percent of patients achieved an early virologic response (EVR), defined as greater than or equal to 2 log10 (100-fold) reduction in virus after 12 weeks of treatment, compared to 88 percent in the pooled 800 mg/day arms (arms C, D and E*; n=92). At 12 and 16 weeks, 71 percent and 73 percent, respectively, of patients in the 200 mg/day arm reached undetectable virus levels below 600 copies/mL compared to 73 percent and 74 percent in the pooled 800 mg/day arms. After 12 and 16 weeks, 45 percent and 62 percent, respectively, of patients in the 200 mg/day arm reached undetectable virus levels below 20 copies/mL, compared to 56 percent and 61 percent in the pooled 800 mg/day arms. >

From Bear Stearns:
"The key question is whether lower doses of NM-283 are efficacious". We maintain that the answer is unknowable at this time, and this is probably why the FDA won't allow initiation of Phase III until more data collected."

Looking good so far...

[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.