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Boehringer Ingelheim announces EFFISAYIL 2 of spesolimab meets primary and key secondary endpoint for prevention of generalized pustular psoriasis flares

Ingelheim, Germany
Tuesday, January 31, 2023, 11:00 Hrs  [IST]

Boehringer Ingelheim announced that the 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. Safety data were in line with previously conducted clinical trials with spesolimab.

“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. 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.

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

Spesolimab is a novel, humanized, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signalling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP. 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.

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.

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. 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.

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.

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

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

GPP is a rare, heterogenous and potentially life-threatening neutrophilic skin disease, which is clinically distinct from plaque psoriasis. GPP is caused by neutrophils (a type of white blood cell) accumulating in the skin, resulting in painful, sterile pustules all over the body. The clinical course varies, with some patients having a relapsing disease with recurrent flares, and others having a persistent disease with intermittent flares. While the severity of GPP flares can vary, if left untreated they can be life-threatening due to complications such as sepsis and multisystem organ failure. This chronic, systemic disease has a substantial quality of life impact for patients and places an increased burden on healthcare systems. GPP has a varied prevalence across different geographical regions and more women are affected than men. There is a high unmet need for treatments with an acceptable safety profile that can prevent the occurrence of GPP flares.

GPP flares can lead to hospitalization with serious complications, including heart failure, renal failure and sepsis, with the unpredictability and severity of these flares greatly affecting a person’s quality of life.

Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need.


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