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
FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products30.6.2026 19:19:00 EEST | Press release
Philip Morris International Inc. (PMI) (NYSE: PM) today announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products. These are the first MRTP orders granted for nicotine pouches, allowing PMI U.S. to market the following claim for the authorized ZYN products: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” “FDA’s decision is an important moment for the more than 45 million legal-age nicotine consumers in America,” saidStacey Kennedy, PMI U.S. CEO. “Today’s news ensures these adultshave access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease and lung cancer,” she added. “More broadly, it reinforces the agency’s science-based approach to evaluating products across the co
Caidya Announces Strategic Combination with Simbec-Orion Bridging Early Scientific Insight and Global Clinical Execution30.6.2026 18:00:00 EEST | Press release
Caidya today announced a strategic combination with Simbec-Orion designed to close the divide between early scientific insight and global clinical execution. The combination of Caidya and Simbec-Orion creates a differentiated specialty clinical CRO platform that enables programs to scale, maintaining focus, speed, and accountability. The strategic combination brings together complementary strengths to create a more complete development partner for innovative biopharma companies. With established operations across Europe, the Americas, APAC, and China, the combined organization provides meaningful expertise and execution capabilities in the regions that matter most. Simbec-Orion brings early-phase clinical pharmacology capabilities alongside deep therapeutic expertise for later stage complex oncology and rare disease trials, helping sponsors shape critical decisions early in the development lifecycle. Together, the organizations strengthen their ability to support complex, cross-border
Archer® Proves Purpose-Built AI Beats General-Purpose LLMs on Regulatory Change Management: 95% Verified Accuracy, 80x Faster, 92% Lower Cost30.6.2026 17:13:00 EEST | Press release
For enterprises deploying AI in compliance, a wrong date is a missed deadline. The more dangerous failure is a wrong answer the model returns with high confidence, one that flows silently into a compliance calendar and is only discovered after the window has passed. Archer® today released results showing purpose-built AI beats a general-purpose large language model (LLM) on regulatory work, and it’s not close. This head-to-head test compared Archer’s purpose-built, vertical-specific AI and proprietary data sets against a leading general-purpose LLM, on a core compliance task: determining the publication, effective and comment-close dates of regulatory documents across six jurisdictions. General-purpose models are a genuine breakthrough, and this is no referendum on their quality. The question Archer set out to answer is narrower and more practical: what it takes to make a specific, high-stakes determination reliable, fast and affordable at scale. A vertical, domain-focused process, gro
Altasciences Supports Key Development Milestone for Steel Therapeutics’ Lead Therapeutic Candidate, Fizurex™30.6.2026 17:08:00 EEST | Press release
Altasciences, a leading drug development organization, today announced a significant milestone in the development of Steel Therapeutics, Inc.’s pivotal toxicology study for its lead product candidate, Fizurex™, for the treatment of anal fissures. The successful completion of the study plays a significant role in the advancement of Fizurex™ toward first-in-human trials. The GLP-compliant study demonstrated a favorable safety profile, which has advanced Steel Therapeutics' plans to submit an Investigational New Drug (IND) application for Fizurex™ to the FDA in Q3 2026. Fizurex™, a patent-pending, single-use topical wipe, was designed to provide a standardized, accessible treatment option for a painful and often undertreated medical condition. The product builds on years of use through compounding pharmacy prescriptions and is now advancing toward clinical development and regulatory review. "We are proud to have supported Steel Therapeutics with the generation of the high-quality safety d
Interactive Brokers Expands Access to Korean Equities with Launch of Nextrade ATS30.6.2026 17:00:00 EEST | Press release
Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced the launch of select Korean equities through Nextrade, South Korea's first Alternative Trading System (ATS). The addition of Nextrade builds on Interactive Brokers' earlier launch of the Korea Exchange (KRX), through which it became the first major US-based broker to provide global investors with direct access to Korean equities. Clients trading on Nextrade benefit from significantly extended trading hours and access to additional liquidity. Interactive Brokers has enabled IB SmartRouting℠ across both the Korea Exchange (KRX) and Nextrade, automatically routing orders to the venue offering the best price. This helps clients achieve best execution while providing greater flexibility and more opportunities to participate in one of Asia's most dynamic equity markets. Korea's equity market ranks among the top global exchanges by market capitalization and is home to world-leading companies such as Samsung Electr
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