Spesolimab meets primary and key secondary endpoint for prevention of generalized pustular psoriasis flares

• Spesolimab EFFISAYIL^™ 2 trial showed      significant prevention of generalized pustular psoriasis (GPP) flares for      up to 48 weeks^1,2

• Results build on data from the EFFISAYIL^™      1 trial, demonstrating the rapid and sustained pustular and skin clearance      in flaring adult GPP patients treated with spesolimab³

• GPP is a rare and unpredictable systemic skin      disease that is distinct from plaque psoriasis in both its disease      mechanism and severity⁴

INGELHEIM, Germany -- (BUSINESS WIRE) --

EFFISAYIL^™ 2 met its primary and key secondary endpoint, demonstrating that spesolimab, an anti-interleukin-36 receptor antibody, can prevent flares in adolescents and adults with generalized pustular psoriasis (GPP) up to 48 weeks.^1,2 Safety data were in line with previously conducted clinical trials with spesolimab.

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“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,” said Carinne Brouillon, Member of the Board of Managing Directors, responsible for Human Pharma, Boehringer Ingelheim. “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.”

GPP is a rare skin disease, which is distinct from plaque psoriasis.⁴ GPP flares greatly affect a person’s quality of life and can lead to serious and life-threatening complications, including heart failure, renal failure, and sepsis.⁴

Spesolimab (marketed as SPEVIGO^®) is currently indicated for the treatment of GPP flares in adults.

About spesolimab

Spesolimab is a novel, humanized, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP.^4,6,7 Spesolimab has been approved by regulatory authorities in several countries including the US, Japan, Mainland China and the European Union to treat GPP flares in adults.^8,9

It is the first approved treatment to specifically target the IL-36 pathway for the treatment of GPP flares that has been evaluated in a statistically powered, randomized, placebo-controlled trial. Further spesolimab data is expected later this year, including the final EFFISAYIL^™ 2 results investigating prevention of GPP flares. Spesolimab is also under investigation for the treatment of other IL-36 mediated skin diseases.¹⁰

About the EFFISAYIL^™ clinical trial program

The EFFISAYIL^™ clinical trial program includes:

• EFFISAYIL^™ 1: Treatment with      spesolimab demonstrated rapid pustular and skin clearance in patients with      GPP flares, sustained over 12 weeks.³ These results supported      the approval of spesolimab (SPEVIGO^®) as the first specific      treatment for GPP flares in adults in major markets including the US,      Japan, Mainland China and the European Union.^8,9

• EFFISAYIL^™ 2: A multicenter,      randomized, double-blind, placebo-controlled Phase IIb study evaluating      the efficacy and safety of maintenance treatment with subcutaneous (SC)      spesolimab for the prevention of GPP flares and sustained control of GPP      symptoms in adolescents and adults.^1,2

• EFFISAYIL^™ ON: To evaluate the      long-term safety and efficacy of Spesolimab in patients with GPP, who have      completed previous Spesolimab trials.⁵

Results from the EFFISAYIL^™ 2 and EFFISAYIL^™ ON trials will be presented later this year.