Spesolimab (BI 655130): IL36R antibody

Spesolimab is a first-in class anti-IL-36 receptor antibody from Boehringer Ingelheim´s own research. It is being investigated in multiple potentially IL-36 pathway mediated auto-inflammatory diseases with generalized pustular psoriasis (GPP) as the lead indication. Spesolimab is marketed as SPEVIGO® and approved for the treatment of GPP flares in adults in almost 40 countries, incl. the U.S.A., Japan, Mainland China, and the European Union, and under review by other regulatory authorities. The approvals and submissions were based on positive pivotal Phase II data from the EFFISAYIL® 1 trial. 

Early July 2023, Spesolimab demonstrated superiority vs. placebo in preventing GPP flares for up to 48 weeks in the EFFISAYIL® 2 trial. Spesolimab has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration and the Center for Drug Evaluation of China’s National Medical Products Administration as an investigational treatment for the prevention of GPP flares. Spesolimab is also under investigation for the treatment of other IL-36 mediated skin diseases, such as Hidradenitis Suppurativa (HS).