Anaptysbio makes investors sweat some more
Anaptysbio is playing an increasingly dangerous game with its biggest pipeline hope, the anti-IL-36 receptor MAb imsidolimab. Its stock opened down 10% this morning after the project yesterday flunked the mid-stage Harp trial in hidradenitis suppurativa, marking its second failure after a palmoplantar pustulosis (PPP) study read out negatively last year. Yet Anaptysbio has already taken imsidolimab into phase 3, albeit in a different autoimmune condition, generalised pustular psoriasis (GPP); not only that, but the decision to start pivotal development was made on the strength of data in just eight phase 2 subjects. Still, it has not been plain sailing for the company’s anti-IL-36 receptor competitors either. Boehringer’s spesolimab was filed with priority review for GPP, but its Pdufa date, which the group had told Evaluate Vantage fell in May/June, came and went with no announcement. Boehringer earlier hinted that its PPP data were not especially impressive, though work here continues. And two phase 1 studies of Regeneron’s REGN6490 were terminated on clinicaltrials.gov last year; that project no longer appears in the group’s R&D pipeline.
| Clinical-stage anti-IL-36 receptor MAbs | ||
|---|---|---|
| Project | Company | Status |
| Spesolimab | Boehringer Ingelheim | Filed for GPP (May/Jun 2022 Pdufa date) |
| Ph2 for hidradenitis suppurativa, completed Jan 2022 | ||
| Ph2 for PPP | ||
| Ph2 for ulcerative colitis | ||
| Imsidolimab | Anaptysbio | Ph3 Gemini-1 for GPP |
| Ph2 for acneiform rash | ||
| Ph2 for ichthyosis | ||
| Ph2 Harp for hidradenitis suppurativa (failed) | ||
| Ph2 Poplar for PPP (failed) | ||
| REGN6490 | Regeneron | 2 ph1 trials terminated |
| GPP=generalised pustular psoriasis; PPP=palmoplantar pustulosis. Source: clinicaltrials.gov & Evaluate Pharma. | ||
Boehringer's spesolimab received US approval, as Spevigo, for GPP flares the day after this article was published.
