Shots:

• The P-II (Effisayil 1) trial evaluates spesolimab (900mg, IV) vs PBO in a ratio (2:1) in 53 patients with a GPP flare for ~12wks.
• The study met the 1EPs i.e., patients treated with spesolimab showed no visible pustules (54% vs 6%), patients achieved clear/almost clear skin (43% vs 11%) & demonstrated an improvement in signs and symptoms of GPP in patients who experienced a flare after 1wks., AEs were reported in 66% & 56% of patients
• Spesolimab is a novel, humanized & selective Ab that blocks the activation of the IL-36R & has received ODD & BTD from the US FDA for the treatment of GPP flares. Additionally, the therapy also received BTD from the CDE for the same indication

Ref: Boehringer Ingelheim | Image: Boehringer Ingelheim