Anaptysbio’s attempts to recover from the painful failure of its eczema candidate etokimab have taken a knock: the biggest trial conducted so far on its next pipeline hope, imsidolimab, has bombed. The anti-IL-36R project was tested in 59 patients with moderate to severe palmoplantar pustulosis (PPP), but the company could only muster various numerical improvements over placebo; on the primary endpoint the study was a clear bust. PPP is a non-fatal form of pustular psoriasis that, like other manifestations of the disease, is thought to be driven by IL-36 signalling. Generalised pustular psoriasis (GPP) is the big prize here, a setting in which Anaptysbio is pushing into phase III on the back of data in eight patients. The competitor to watch is Boehringer Ingelheim, which claimed a win in GPP with a similarly targeted MAb, spesolimab, a couple of years ago. The private group has also run trials in PPP but has been cagey about results, suggesting a benefit here is harder to tease out. Still, Anaptysbio investors were clearly hoping for stronger signals from imsidolimab in PPP before the push into pivotal trials; shares in the biotech plunged 39% in early trade.
|Topline Ph2 Poplar data with imsidolimab/ANB019|
|LSMD PPPASI Relative to baseline||Imsidolimab||Placebo||Difference||p-value|
|Week 16 (primary endpoint)||-6.1||-6.3||0.2||0.93|
|LSMD; least-squares mean difference, PPPASI = palmoplantar pustular psoriasis area severity index. Source: press release.|