The EFFISAYIL 2 trial demonstrated that spesolimab can prevent flares in adolescents and adults with GPP for up to 48 weeks. Credit: Eszter Miller from Pixabay.

Boehringer Ingelheim has reported positive data from the Phase IIb EFFISAYIL 2 clinical trial of spesolimab for generalised pustular psoriasis (GPP) flares.

The randomised, multicentre, double-blind, placebo-controlled trial has been designed to evaluate the safety and efficacy of maintenance treatment with subcutaneous (SC) spesolimab to prevent GPP flares and sustained symptom control in adolescents and adults.

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The EFFISAYIL 2 trial of spesolimab met its primary and key secondary endpoints.

It demonstrated that the anti-interleukin-36 receptor antibody can prevent flares in adolescents and adults with GPP for up to 48 weeks.

Safety data in the study was found to be in line with clinical trials that were conducted earlier with spesolimab.

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Boehringer Ingelheim Human Pharma Board of Managing Directors member Carinne Brouillon said: “Painful GPP flares can occur suddenly, escalate quickly, and may require urgent hospital care, leaving people anxious and uncertain about what the future might hold.

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“The EFFISAYIL 2 results reinforce the potential of spesolimab to prevent GPP flares, giving patients the power to plan their lives, regardless of their disease. We look forward to presenting the data later this year and sharing the findings with regulatory authorities.”

Marketed as SPEVIGO, the new, humanised, selective antibody spesolimab is currently indicated to treat GPP flares in adults. 

Regulatory authorities in several countries including Japan, the US, Mainland China, and the European Union granted approval for spesolimab to treat GPP flares in adults.

The antibody is also being investigated for the treatment of other IL-36 mediated skin diseases.

EFFISAYIL 2 is part of the EFFISAYIL clinical trial programme, which also includes EFFISAYIL 1 and EFFISAYIL ON studies.

Last October, Boehringer Ingelheim enrolled the first subject in the Phase III FIBRONEER-IPF trial of BI 1015550 to treat idiopathic pulmonary fibrosis patients.