Sorriso Pharmaceuticals has announced positive results from its Phase 1b clinical trial evaluating SOR102, an oral, dual-acting biologic for ulcerative colitis (UC). The study, which assessed safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy, met its primary objectives and showed promising activity across multiple clinical endpoints. This marks the first successful demonstration of an orally dosed antibody delivering clinical efficacy.
The randomized, double-blind, placebo-controlled trial enrolled 22 patients across two sites, who were randomized to receive one of two SOR102 doses or placebo for six weeks. According to Sorriso, patients in the high-dose SOR102 group achieved statistically significant separation from placebo across multiple clinical endpoints, including Mayo Score clinical response, modified Mayo Score clinical response, symptomatic remission, and mean decreases from baseline in Mayo Score, modified Mayo Score, and UC-100 score.
Targeting TNFa and IL-23
SOR102 simultaneously inhibits TNFα and IL-23(p19), two clinically validated drivers of inflammatory bowel disease (IBD). This dual-targeting approach delivers combination therapy locally within inflamed tissue with minimal systemic exposure, potentially increasing efficacy through simultaneous blockade of different mechanisms of IBD.
"Our Phase 1b results with SOR102 mark a significant milestone for Sorriso Pharmaceuticals and the field of autoimmune therapeutics," said Ciara Kennedy, Chief Executive Officer of Sorriso Pharmaceuticals. "We believe SOR102, a first-in-class, oral biologic that inhibits TNFα and IL-23, two validated pathways in inflammatory bowel disease, will be a game changer. These clinical data for SOR102 provide strong evidence for its potential to provide an effective and convenient oral treatment option for patients living with ulcerative colitis. We are excited to advance SOR102 into Phase 2 development."
Next Steps for SOR102
Based on the Phase 1b results, Sorriso Pharmaceuticals plans to initiate a Phase 2 clinical trial in 2025 to further evaluate SOR102 in a larger patient population. The detailed study results will be presented at the upcoming 20th Congress of ECCO in Berlin, Germany, from February 19-22, 2025.
"Ulcerative colitis remains a challenging condition, but we have seen promising rates of clinical remission from dual inhibition of TNFα and IL-23 using systemically delivered antibodies," said Carlos Sattler, Chief Medical Officer of Sorriso Pharmaceuticals. "These results, observed after just six weeks of treatment, compare favorably to approved treatments and underscore SOR102's potential to redefine the treatment paradigm by targeting these two critical inflammatory pathways with a convenient oral therapeutic."
