Preliminary Phase 2a Study Data on Orismilast Presented at 20th ECCO Congress

UNION Therapeutics Presents at ECCO Congress

Union Therapeutics recently unveiled promising preliminary data from its Phase 2a investigator-initiated study of orismilast for treating ulcerative colitis (UC) at the 20th European Crohn's and Colitis Organisation (ECCO) congress held in Berlin from February 19-22, 2025. This presentation comes at a time when the need for effective treatments for UC is increasingly pressing.

Ulcerative colitis is a chronic inflammatory bowel disorder distinguished by inflammation and ulceration in the lower gastrointestinal tract, particularly affecting the colon and rectum. Over 1.8 million people in the United States, Japan, and EU5 countries live with UC, and the incidence globally is on the rise. Though there are existing treatment options, many remain unsatisfactory, highlighting a significant unmet need for safer and more effective oral treatments. The condition can alternate between periods of exacerbation, known as relapses, and remission, leading to a severe impact on the quality of life for those affected.

The UCORIS study, a Phase 2a, open-label trial, was designed to assess the safety and efficacy of orismilast, a high-potency PDE4B/D inhibitor, over a 12-week period in adults with moderate to severe UC. The study’s initial findings have been encouraging, with three of the ten enrolled patients reportedly achieving complete remission. As of now, enrollment has concluded, and the team aims to complete the study by 2025.

The Poster Presentation
The poster presented at ECCO, titled “Orismilast for the Treatment of Moderate to Severe Ulcerative Colitis”, showcased the promising outcomes the treatment may offer. Investigators included renowned medical experts such as Trine Velte Honoré, Flemming Bendtsen, Jakob Seidelin, and Johan Burisch, who emphasized the significant need for effective and reliable treatments for this autoimmune bowel disease.

Kim Kjøller, CEO of Union Therapeutics, expressed optimism regarding the initial results, noting the persistent challenges posed by UC and the crucial requirement for advancements in treatment methodologies. He stated, "UC is a systemic autoimmune bowel disease with a high unmet medical need for effective and safe treatments."

Understanding Orismilast
Orismilast is currently under development not just for UC but also for other inflammatory disorders. It demonstrates potent inhibition of Th1, Th2, and Th17 inflammatory pathways by targeting the PDE4B/D subtypes. This compound acts early in the inflammation cascade and is being investigated for its broad anti-inflammatory effects across various cytokines implicated in dermatological and immunological diseases.

Union Therapeutics aims for orismilast to become a safe and effective oral treatment option for numerous autoimmune conditions. The FDA has already cleared Union's Investigational New Drug (IND) application for oral orismilast and granted Fast Track designation for treating both moderate to severe hidradenitis suppurativa and atopic dermatitis.

The data from the UCORIS trial represents a significant stride forward, not only for the treatment of UC but as part of Union Therapeutics' broader mission to enhance treatment options for several immunological diseases. With the completion of this study and the promising preliminary data now in circulation, further development and research on orismilast could lead to substantial improvements in patient care for those afflicted by ulcerative colitis and similar conditions.