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
Airship Announces Results Guarantee; Releases Commissioned Study Finding 476% ROI for Composite Organization22.7.2026 18:00:00 EEST | Press release
Airship, the mobile-first customer experience platform leader, today announced its Airship Results Guarantee, a corporate commitment to achieve predetermined business outcomes for new customers. Concurrently, the company released the results of a separate, commissioned Total Economic Impact™ (TEI) study conducted by Forrester Consulting on behalf of Airship, July 2026. The study found that a composite organization based on interviewed customers achieved a 476% Return on Investment (ROI) with a payback period of less than six months. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722832535/en/ Airship has launched a new results guarantee offer to stand behind its value. Alongside this offer, the team shared the results of a new Total Economic Impact™ (TEI) study commissioned with Forrester Consulting illustrating that a composite organization achieved a 476% ROI with a payback period of less than six months. “We introduced
Arrakis Comes out of Stealth With $38M to Help Industrial Enterprises Compete in the AI Era22.7.2026 16:56:00 EEST | Press release
Arrakis, the AI deployment company helping industrial companies install AI agents for mission-critical operations, today announced a $30 million Series A led by Blossom Capital, with participation from existing investor Accel, which also led the company's $7.5 million seed round. The round brings total funding to around $38 million and includes backing from prominent technology leaders, including Olivier Pomel, founder and chief executive of Datadog, Olivier Godement, OpenAI’s Head of business products and Junaid Hussein, founder of Cambridge Aerospace. Founded in January 2026 by former Accel investor Rafael Quintanilla, together with co-founders Haroun Beltaifa, Romain Fouilland and Mikhail Galkov - alumni of Palantir, DeliveryHero, Revolut, Datadog and ASML - Arrakis helps industrial companies deploy AI into core operational workflows across aerospace, energy, logistics, manufacturing, construction and telecommunications markets. Across the US and Europe, governments and businesses a
Vultr and AMD Support the University of Cambridge's TESSERA AI Project to Accelerate Global Environmental Monitoring22.7.2026 16:00:00 EEST | Press release
Vultr, the world’s largest privately-held cloud infrastructure company, and AMD, a leader in high-performance and AI computing, have announced their support for the University of Cambridge's Energy & Environment Group in developing TESSERA, a groundbreaking AI foundation model designed to monitor environmental change internationally at unprecedented scale. Vultr is providing the computational infrastructure, based on AMD Instinct MI325X accelerators, necessary to generate global embeddings covering Earth's land surface from 2017 to 2025, enabling applications in agriculture, biodiversity conservation, and renewable energy infrastructure monitoring. The collaboration represents a significant advancement in applying artificial intelligence to planetary conservation challenges. TESSERA processes data from European Space Agency Sentinel satellites to create detailed embeddings - compressed AI representations - of every 10-meter square of Earth's surface. TESSERA represents the most accurat
Omilia Appoints Ryan Kam as Chief Marketing Officer to Lead Global Brand and Growth Strategy22.7.2026 15:00:00 EEST | Press release
Omilia, a global leader in Self-Learning Agentic CX, today announced the appointment of Ryan Kam as Chief Marketing Officer (CMO). Ryan will be responsible for Omilia's global brand, demand generation, and marketing strategy as the company scales its go-to-market presence across enterprise markets. In his new role, Kam will own Omilia's global marketing function, spanning brand strategy, demand generation, product marketing, analyst relations and communications. He joins at a moment of significant commercial momentum: Omilia has seen accelerating enterprise demand across all industries and is investing in a marketing engine built to match the pace of its growth. Ryan Kam brings more than 20 years of marketing leadership across some of the most recognized names in enterprise technology. Most recently, he served as CMO at Egnyte, a leader in cloud content security and governance. Prior to that, Kam held the CMO role at LogicMonitor, where he drove growth for one of the leading infrastruc
Echodyne Announces ATAK Integration for MESA® Radar Platform22.7.2026 15:00:00 EEST | Press release
Echodyne, the radar platform company, today announced the availability of an Android Team Awareness Kit (ATAK) plugin for its MESA® radar platform. The integration enables users to configure, control, and visualize data from Echodyne radars within the ATAK environment, supporting military, public safety, and security operations that rely on TAK for shared situational awareness. The plugin extends radar management and visualization capabilities to ATAK users, allowing high-fidelity radar data and system controls to be accessed through a familiar operational interface. By integrating radar data into existing TAK workflows, organizations can streamline deployment, reduce operator workload, and improve access to real-time situational awareness. TAK is a government-developed geospatial platform used across U.S. military, federal, state, and local government organizations, as well as by U.S. partner nations. According to the U.S. Army TAK Product Center, the TAK ecosystem supports 15 Departm
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