Spesolimab meets primary and key secondary endpoint for prevention of generalized pustular psoriasis flares
30.1.2023 11:16:00 EET | Business Wire | Press release
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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230129005023/en/
“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.
For the full press release including ‘Notes to Editors’ and references please visit: press release
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230129005023/en/
Contact information
Boehringer Ingelheim
Corporate Communications
Media + PR
Laura Lessenich
Phone: +49 (6132) 77-173436
Email: press@boehringer-ingelheim.com
Additional information: www.boehringer-ingelheim.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
IQM Secures €50M Financing to Accelerate Global Growth30.3.2026 09:00:00 EEST | Press release
IQM Finland Oy, a global leader in full-stack superconducting quantum computers (“IQM”, “IQM Quantum Computers” or the “Company”), today announced it has secured a €50 millionfinancing package from funds and accounts managed by BlackRock. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260329996942/en/ IQM Radiance quantum computer is located in IQM's showroom in Espoo, Finland. This facility will support acceleration of IQM’s technology roadmap, fuel R&D, support entry into additional markets, and advance IQM’s leadership in quantum computing. This facility was secured prior to IQM’s recent announcement of plans to become the first publicly listed European quantum computing company through a merger with Real Asset Acquisition Corp (“RAAQ”). The facility lowers IQM’s overall cost of capital and improves the flexibility and diversity of its capital base. “The financing package comes at a pivotal time for IQM, as we build momen
Bureau Veritas and Trade Technologies Join Forces to Streamline Global Trade Operations30.3.2026 08:45:00 EEST | Press release
Bureau Veritas, a global leader in Testing, Inspection, and Certification services (TIC), through its Swiss branch Government Services Division, is pleased to announce a strategic agreement with Trade Technologies, the leading provider of trade finance automation, connectivity and transaction management services. This collaboration is a significant step toward reducing the complexities of international trade operations, particularly in regions where regulatory and inspection controls remain stringent. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260329411683/en/ Addressing Critical Trade Finance Challenges The agreement comes at a pivotal time for global trade. Letters of Credit (LCs) continue to serve as essential instruments in international commerce, particularly across the Middle East and Africa, where counterparty risk, foreign exchange controls, sanctions exposure, and regulatory oversight face ongoing challenges. In
Consortium Led by Axelspace Selected for Japan’s Space Strategy Fund Project “Technology to Enhance Capability of Next Generation Earth Observation Satellites”30.3.2026 02:35:00 EEST | Press release
Axelspace Corporation, Meisei Electric Co., Ltd., ANA HOLDINGS INC., and JIJ Inc. are pleased to announce that their jointly proposed technology development project has been selected for Japan Aerospace Exploration Agency (JAXA)’s Space Strategy Fund under the theme “Technology to Enhance Capability of Next Generation Earth Observation Satellites.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260323044518/en/ Conceptual Diagram of the project. Under this Space Strategy Fund initiative, spectrometers will be newly developed and demonstrated in orbit. In the future, the project envisions the establishment of a satellite constellation capable of observations at different times of the day. Project Summary (Planned) Technology Development Theme: Technology to Enhance Capability of Next Generation Earth Observation Satellites Project Title: Source-Specific CO2 Emission and Uptake Monitoring through Satellite Constellation and Ai
Takeda’s Zasocitinib Delivered Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, Affirming Promise to Reshape Psoriasis Care28.3.2026 21:00:00 EET | Press release
Takeda(TSE:4502/NYSE:TAK)today announced new data from the two pivotal Phase 3studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).1 Presented as a late-breaking abstract at the 2026 American Academy of Dermatology (AAD) Annual Meeting, these data show that convenient once-daily oral zasocitinib demonstrated rapid and durable skin clearance with a safety profile consistent with Phase 2b studies.1,2 “Our goal in psoriasis treatment is clear or almost clear skin, and previously this has been achieved primarily with injectable therapies,” said Melinda Gooderham, MSc, MD, FRCPC, dermatologist, SKiN Centre for Dermatology, Peterborough, Ontario, Canada, principal investigator for the Latitude PsO studies and presenting author. “These efficacy and safety results show it’s possible for a once-daily pill to deliver rapid, lasting skin clearance, highlighting the potential of zasoc
Incyte Announces New Positive 54-Week Late-Breaking Data for Povorcitinib in Hidradenitis Suppurativa at the 2026 American Academy of Dermatology (AAD) Annual Meeting28.3.2026 21:00:00 EET | Press release
Incyte (Nasdaq:INCY) today announced 54-week data evaluating the safety and efficacy of povorcitinib (INCB54707), an oral small-molecule highly-selective JAK1 inhibitor, from the pivotal Phase 3 STOP-HS clinical trial program in adult patients (≥18 years) with moderate to severe hidradenitis suppurativa (HS). The late-breaking oral presentation of these data is taking place at the 2026 American Academy of Dermatology (AAD) Annual Meeting, being held March 27-31, 2026, in Denver (Session: S034 – Late-Breaking Research: Session 2. Saturday, March 28, 2026, 1:00-4:00 p.m. MT). “The 54-week results from the STOP-HS program deliver compelling, long-term evidence supporting the potential of povorcitinib for patients with moderate to severe HS,” said Pablo J. Cagnoni, M.D., President and Global Head of Research and Development, Incyte. “Across both studies, povorcitinib demonstrated substantial and durable improvements over time in key measures of treatment success and meaningful clinical ben
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom