Replies to post #152815 on Biotech Values

[nuere]

For the sake of comparison, this is AMGN's Kineret (a different anti IL-1 antibody, which is behind XOMA in Behçet’s disease) pilot trial - randomized, controlled, in 25 patients in US:

For your information, Anakinra is not an antibody, its the natural IL-1 receptor antagonist, which means that instead of a monthly dose you have below dosing..
100 mg subcutaneously daily with dose escalation up to 200 mg daily for three months. Responders at months 3-6 will be randomised to continuation of drug vs. placebo

[piggerpig]

True the xoma trial was uncontrolled - but the condition was not prone to "spontaneous recovery" or placebo effects - you either see well or you have constrained vision. It was pretty clear the results showed efficacy. The questions that remain are toxicity, duration of response, etc. and indications beyond bechets U

[mcbio]

I amuse I'm stating the obvious here but that pilot XOMA's trial was an open, uncontrolled, in 7 patients only, in Turkey (ard.bmj.com/content/71/4/563.abstract).

That's no laughing matter (-g-); certainly a small, uncontrolled trial doesn't equate to Phase 3 success.

Although data from that pilot study are good, I somehow get the feeling of rushing into phase III.

It may well be a case of that. And this is why I would probably wait for further PoC in the Phase 2 acne data due shortly. Still, it's at least an initial sign of PoC and the XOMA market cap doesn't seem like there is a lot of success baked into the valuation for the drug. And the initial indication and those prior results seem fairly objective and not one that would be prone to a large placebo effect (obviously, you never know).

[DewDiligence]

Servier also completed a phase-2 study with 21 patients. I haven't examined the results.