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 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: & Evaluate Pharma.

Boehringer's spesolimab received US approval, as Spevigo, for GPP flares the day after this article was published.

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