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 and Real Asset Acquisition Corp. to Host Conference Call/Webcast to Discuss Proposed Transaction27.2.2026 14:00:00 EET | Press release
IQM Finland Oy, a global leader in full-stack superconducting quantum computers (“IQM”, “IQM Quantum Computers” or the “Company”), and Real Asset Acquisition Corp. (Nasdaq: RAAQ), a special purpose acquisition company (“RAAQ”), announced that they will host a conference call to discuss their recently announced business combination, including certain transaction highlights. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260227472716/en/ IQM Radiance quantum computer As previously disclosed, on February 23, 2026, IQM and RAAQ announced they have entered into a definitive business combination agreement, which will result in IQM becoming a public company and listing American Depositary Shares on one of the two leading U.S. stock exchanges. The transaction provides funding with the aim to accelerate IQM’s technology and commercial development towards fault-tolerance quantum computing, further advancing its position as a leading p
HighRadius Launches $0 Implementation Fee, $0 Subscription Fee via Outcome Based Pricing for oCFO Software27.2.2026 13:00:00 EET | Press release
HighRadius launches Office of the CFO first Outcome Based Pricing with $0 Implementation fee and $0 Subscription until Go-Live. Customers only pay a fraction of realized gains based on P&L impact. Chapter 1: Outcome Based Pricing (OBP) Introduction of OBP: HighRadius, a provider of 190+ AI agents for Order-to-Cash, Accounts Payable, Record-to-Report, and Treasury introduces Outcome Based Pricing (OBP). Three Components of OBP: Customers pay a) $0 in Implementation fees, b) $0 in Subscription fees until Go Live, c) HighRadius earns a fraction of the actual savings realized by the client. Chapter 2: US GAAP & ASC 606 Constraints Not Designed for Innovation: The traditional ASC 606 model requires companies to standardize and recognize revenue based on contractual obligations. For a traditional SaaS subscription, the obligation is access to software over time. AI agents are designed to deliver quantifiable, real-time Business Outcomes that do not fit the traditional accounting framework. C
Kioxia Appoints Yoshihiko Kawamura as Chief Financial Officer27.2.2026 10:15:00 EET | Press release
Kioxia Holdings Corporation (TOKYO:285A), a world leader in memory solutions, today announced the appointment of Yoshihiko Kawamura as Chief Financial Officer (CFO), effective April 1, 2026. Mr. Kawamura brings extensive international experience to Kioxia, having held assignments at Mitsubishi Corporation’s U.S. headquarters, served as General Manager of its Chicago office, and completed a tenure at the World Bank. At Hitachi, Ltd., he held senior leadership positions, including Chief Strategy Officer (CSO), Chief Financial Officer (CFO), and Chief Risk Management Officer (CRMO), where he was instrumental in leading the company’s management reforms. Since joining Kioxia as Executive Vice President in June 2025, Mr. Kawamura has worked closely with the executive team to advance the business through strategic capital and financial planning. Following its initial public offering on the Prime Market of the Tokyo Stock Exchange in December 2024, Kioxia is entering a new phase of growth char
DNP Invests in Rapidus to Support the Establishment of Mass Production for Next-Generation Semiconductors27.2.2026 09:18:00 EET | Press release
Dai Nippon Printing Co., Ltd. (DNP, TOKYO:7912) today announced that it has participated in Rapidus Corporation’s funding round as one of the round investors. This strategic funding initiative supports Rapidus’ plan to steadily progress from its current R&D phase to mass production of 2nm (10⁻⁹ meters) logic semiconductors by 2027. Through this initiative, DNP will advance the development and mass production of EUV lithography photomasks and support Rapidus as it establishes a mass production system for 2nm & next-generation semiconductors. Background In recent years, the rise in energy consumption, in line with increased data generation, has become a challenge, driving demand for next-generation semiconductors capable of improving device performance and reducing power consumption. Next-generation semiconductors manufactured using EUV lithography enable the formation of finer patterns on silicon wafers compared to currently available technologies. This in turn is boosting expectations
EdgeConneX Looks to Enter Swedish Market as Part of European Data Center Expansion Strategy27.2.2026 09:05:00 EET | Press release
EdgeConneX®, an EQT portfolio company with an extensive Pan-European data center footprint, looks to expand its presence with a new site located in Skellefteå, Sweden. The data center site will be acquired from Lyten, a global company that specializes in lithium-sulfur batteries and energy storage. The site would support EdgeConneX broader strategy to expand digital infrastructure capacity across the Nordics. Subject to the completion of applicable administrative and regulatory processes, EdgeConneX will look to develop a data center campus with potential capacity of up to one gigawatt in support of future AI and cloud computing workloads. Upon completion, the data center campus would be one of the largest facilities in Europe that would be primarily powered by renewable energy. “Sweden represents an attractive long‑term market for digital infrastructure investment. The country’s access to renewable energy, stable power grid, technical workforce and strong sustainability framework alig
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