Sorriso Pharma Reports Positive Phase 1b Results for SOR102 in Ulcerative Colitis

Sorriso Pharmaceuticals has announced encouraging results from a Phase 1b clinical trial involving their novel oral biologic, SOR102, aimed at treating ulcerative colitis (UC). This trial marks an important step for the company, as it is the first to showcase the clinical efficacy of an orally administered antibody. SOR102 targets two key inflammatory pathways, TNFα and IL-23, which are significant in the progression of inflammatory bowel diseases.

The clinical trial was designed as a randomized, double-blind, and placebo-controlled study, enrolling 22 patients across two locations. Participants were divided to receive either one of two doses of SOR102 or a placebo over a six-week period. The trial primarily focused on evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SOR102. The results were promising, showing a positive safety profile and demonstrating statistically significant improvements in several clinical endpoints for patients in the high-dose group compared to those receiving the placebo. These endpoints included the Mayo Score clinical response, modified Mayo Score clinical response, and symptomatic remission, among others.

The success of this trial paves the way for Sorriso Pharmaceuticals to proceed with a Phase 2 clinical trial in 2025, which will assess SOR102 in a broader patient population. The company's CEO, Ciara Kennedy, expressed optimism about the impact of SOR102, noting its potential as a first-in-class oral therapeutic for ulcerative colitis. Kennedy emphasized that SOR102's unique mechanism of simultaneously inhibiting TNFα and IL-23 could significantly improve treatment options for patients with UC, offering an effective and convenient oral solution.

Dr. Carlos Sattler, the Chief Medical Officer at Sorriso Pharmaceuticals, highlighted the challenges of treating ulcerative colitis and expressed excitement about the dual inhibition strategy. He noted that the rapid improvements observed within just six weeks of treatment with SOR102 were favorable compared to existing treatment options. Dr. Vipul Jairath, a Professor of Medicine and Chair of Sorriso’s Scientific Advisory Board, lauded the innovative approach of SOR102 as a groundbreaking advancement in addressing the pathophysiology of UC. He underscored the significance of SOR102's dual-targeting capability and its potential to transform patient care.

The findings from this study will be shared at the upcoming 20th Congress of ECCO in Berlin, Germany, scheduled for February 2025. This will provide a platform for Sorriso Pharmaceuticals to present detailed data and engage with the broader scientific community.

SOR102 is described as a dual-acting oral biologic that inhibits both TNFα and IL-23(p19), key influencers in inflammatory bowel disease. By delivering this combination treatment directly within inflamed tissues while minimizing systemic exposure, SOR102 aims to enhance therapeutic efficacy. This innovative approach aligns with Sorriso Pharmaceuticals’ broader mission to develop disease-modifying antibodies for immune-mediated conditions, such as ulcerative colitis and Crohn’s disease. Their platform focuses on creating potent antibodies that retain their activity throughout the human intestinal tract, offering new hope for effective oral treatments in this field.