Spesolimab meets primary and key secondary endpoint for prevention of generalized pustular psoriasis flares
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
Murata Unveils World’s First 15nF/1.25kV C0G MLCC in 1210-inch Size2.12.2025 04:00:00 EET | Press release
Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) announces the launch and mass production of its multilayer ceramic capacitor (MLCC) featuring a capacitance of 15nF, a rated voltage of 1.25kV, and C0G characteristics in the compact 1210-inch (3.2mm x 2.5mm) size. This product delivers highly efficient power conversion and stable performance under high-voltage conditions, making it suitable for onboard chargers (OBCs) in electric vehicles (EVs) and power supply circuits in high-performance consumer devices. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251201104421/en/ [Murata Manufacturing Co., Ltd.] 15nF/1.25kV/C0G MLCC in 1210-inch Size Resonant and snubber circuits are essential for efficient power conversion and suppressing current and voltage peaks. In both circuits, repeated exposure to high voltage and high current can cause even slight changes in component performance, leading to efficiency loss or
With 40% of Agentic AI Projects Predicted to Fail, Leading Software Developer Says Compliance Is the One Place Where Agentic AI Will Thrive2.12.2025 02:01:00 EET | Press release
The CEO of one of the world’s leading global compliance software developers, Ideagen, has today (December 2, 2025) said compliance represents the one domain where autonomous AI will succeed – despite technology insights company Gartner® warning "… over 40% of agentic AI projects will be canceled by the end of 2027”. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251201511477/en/ Ben Dorks, Ideagen CEO Speaking at the launch of their own agentic AI platform Ideagen Mazlan, Ben Dorks said: “Autonomous AI will succeed in compliance because failure is measurable, stakes are high and outcomes are binary. “AI that continuously monitors jurisdictional or industry specific compliance frameworks, detects patterns across thousands of records, raises actions for others to follow, flags gaps before audits, autonomously? That's agentic. It will literally save lives and is the most transformative shift in protecting people, products and p
VeriSilicon’s NPU IP VIP9000NanoOi-FS has Achieved ISO 26262 ASIL B Certification2.12.2025 02:00:00 EET | Press release
VeriSilicon (688521.SH) today announced that its NPU IP VIP9000NanoOi-FS has successfully achieved ISO 26262 ASIL B certification, marking a significant milestone in the functional safety capabilities of the company’s neural network processing unit portfolio. This IP features an architecture streamlined for seamless SoC integration, delivering high-quality inference with low power consumption and a compact silicon footprint. The certificate was issued by SGS-TÜV Saar, an international testing, inspection and certification institution. As part of VeriSilicon’s VIP9000 series, the VIP9000NanoOi-FS IP is designed for automotive and edge AI applications, providing high-performance neural network processing with a safety-compliant architecture. The IP supports a wide range of AI inferencing models including Large Language Models (LLMs) and Convolutional Neural Networks (CNNs), with hardware-accelerated AI inference, enabling real-time applications such as object and scene detection, augment
UMA Launches from Europe to Shape the Global Future of Physical AI2.12.2025 00:52:00 EET | Press release
UMA (Universal Mechanical Assistant), a new robotics intelligence company founded by former leaders from Tesla, Google DeepMind, Nvidia and Hugging Face, launches today with a clear goal: to bring advanced AI into the physical world and build humanoid robots ready for real work, in real environments, at scale. UMA’s founders were instrumental in shaping the last decade of breakthroughs in deep learning, robotics and open-source AI. They are convinced that the next era of artificial intelligence won’t unfold on screens, it will happen in warehouses, hospitals, labs, factories and homes, where machines must face friction, unpredictability and human complexity. UMA is built for this transition: from digital intelligence to physical autonomy. AI Is Moving Off the Screen and into the World The past ten years gave rise to generative models, multimodal systems and language-based intelligence. The next decade will be defined by robotics, powered by an AI that can see, move, manipulate and make
FlightSafety International Appoints Eric Hinson as Chief Executive Officer2.12.2025 00:00:00 EET | Press release
FlightSafety International Inc. today announced the appointment of Eric Hinson as chief executive officer, effective immediately. Hinson will succeed former president Barbara Telek who recently announced her retirement. Hinson’s appointment marks a return to FlightSafety. He served as an executive vice president from 2009 to 2012 before leaving to be the president and CEO of Simcom International, Inc. Hinson started his aviation career as a naval aviator flying tactical aircraft in training, fleet, and operational test squadrons. Today, he is an active ATP-rated pilot with more than 5,000 total flight hours. He brings a unique operational perspective to the position—one that blends executive leadership with firsthand experience. In addition to FlightSafety and Simcom, Hinson has served in a variety of senior leadership positions at leading aviation companies, including Honeywell, Gulfstream, and Piaggio Aerospace. He also served as a board member of the General Aviation Manufacturer As
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