Sorriso Pharmaceuticals, a biopharmaceutical company focused on developing novel oral antibodies for immune-mediated diseases, today announced positive results from its Phase 1b clinical trial of SOR102. This oral, dual-acting biologic targets TNFα and IL-23 and was tested in patients with ulcerative colitis (UC). The trial met its primary objectives, showing a favorable safety and tolerability profile. Moreover, key exploratory efficacy endpoints revealed promising activity of SOR102 across several clinical measures. Notably, this marks the first successful demonstration of an orally dosed antibody delivering clinical efficacy.
Sorriso Pharmaceuticals, a biopharmaceutical company focused on developing novel oral biologics for immune-mediated diseases, has announced promising results from its Phase 1b clinical trial of SOR102. The oral biologic targets TNFα and IL-23, two validated pathways involved in inflammatory bowel diseases like ulcerative colitis (UC). The trial demonstrated SOR102’s potential as a highly effective, convenient oral treatment for UC, marking a significant milestone in autoimmune therapeutics.
“Our Phase 1b results with SOR102 represent a significant achievement for both Sorriso Pharmaceuticals and the broader field of autoimmune treatments,” said Ciara Kennedy, CEO of Sorriso Pharmaceuticals. “As a first-in-class oral biologic, we believe SOR102 will be a game changer. These clinical data strongly support its potential to offer an effective and convenient treatment option for UC patients. We are eager to advance SOR102 into Phase 2 development.”
The randomized, double-blind, placebo-controlled trial enrolled 22 patients across two sites. Participants were assigned to one of two SOR102 dosage groups or a placebo for six weeks. The study assessed various factors, including safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy. Among those who completed the study, patients in the high-dose SOR102 group showed statistically significant improvements over the placebo across multiple clinical endpoints. These included Mayo Score clinical response, modified Mayo Score clinical response, symptomatic remission, and reductions in the Mayo Score, modified Mayo Score, and UC-100 score.
Based on these results, Sorriso Pharmaceuticals plans to initiate a Phase 2 clinical trial in 2025, expanding the study to a larger patient population. “Ulcerative colitis remains a challenging condition, but dual inhibition of TNFα and IL-23 has shown promising rates of clinical remission using systemically delivered antibodies,” said Carlos Sattler, Chief Medical Officer of Sorriso Pharmaceuticals. “These results, seen after just six weeks of treatment, compare favorably to approved treatments and highlight SOR102’s potential to redefine the treatment landscape with an oral option targeting these critical inflammatory pathways.”
Dr. Vipul Jairath, Professor of Medicine at Western University, Canada, and Chair of Sorriso’s Scientific Advisory Board, noted, “As both a clinician and researcher, I’m excited to see SOR102’s progress in addressing the complexities of ulcerative colitis. The dual inhibition of TNFα and IL-23 with an oral product is an innovative approach that holds great promise for transforming patient care. These Phase 1b results provide a solid foundation for further development.”
The full study results will be presented at the 20th Congress of ECCO in Berlin, Germany, from February 19 to 22, 2025.
About SOR102
SOR102 is an oral biologic that simultaneously inhibits TNFα and IL-23(p19), two major drivers of inflammatory bowel disease (IBD). This dual-target approach provides combination therapy locally in inflamed tissue while minimizing systemic exposure.
About Sorriso Pharmaceuticals
Sorriso Pharmaceuticals develops disease-modifying antibodies for immune-mediated diseases such as ulcerative colitis and Crohn’s disease, with a focus on oral biologics that maintain activity throughout intestinal tissue.
