Sorriso's Oral TNFa/IL-23 Inhibitor SOR102 Shows Promise in Ulcerative Colitis Phase 1b Trial
Key Insights
Sorriso Pharmaceuticals' SOR102, an oral dual-acting biologic, demonstrated a favorable safety and tolerability profile in a Phase 1b trial for ulcerative colitis.
The high-dose SOR102 group achieved statistically significant separation from placebo across multiple clinical endpoints, including Mayo Score and symptomatic remission.
SOR102 targets both TNFa and IL-23, two validated pathways in inflammatory bowel disease, offering a potential convenient oral treatment option.
Sorriso PharmaceuticalsSearch company has announced positive results from its Phase 1b clinical trial evaluating SOR102Search drug, an oral, dual-acting biologic for ulcerative colitisSearch disease (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 SOR102Search drug 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
SOR102Search drug simultaneously inhibits TNFα and IL-23Search term(p19), two clinically validated drivers of inflammatory bowel diseaseSearch 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 SOR102Search drug mark a significant milestone for Sorriso PharmaceuticalsSearch company 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-23Search term, two validated pathways in inflammatory bowel diseaseSearch 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 colitisSearch disease. We are excited to advance SOR102 into Phase 2 development."
Next Steps for SOR102
Based on the Phase 1b results, Sorriso PharmaceuticalsSearch company plans to initiate a Phase 2 clinical trial in 2025 to further evaluate SOR102Search drug 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 colitisSearch disease remains a challenging condition, but we have seen promising rates of clinical remission from dual inhibition of TNFα and IL-23Search term using systemically delivered antibodies," said Carlos Sattler, Chief Medical Officer of Sorriso PharmaceuticalsSearch company. "These results, observed after just six weeks of treatment, compare favorably to approved treatments and underscore SOR102Search drug's potential to redefine the treatment paradigm by targeting these two critical inflammatory pathways with a convenient oral therapeutic."