Utah biopharma company Sorriso Pharmaceuticals has confirmed its Phase Ib trial of an oral drug for patients with ulcerative colitis (UC) met its endpoints, as the company prepares for the next phase.
Sorriso’s oral biologic treatment, SOR102, is designed to inhibit the chemicals TNF⍺ and IL-23(p19), known to be drivers of conditions such as inflammatory bowel disease (IBD) and potentially UC. Results from the company’s Phase Ib study (NCT06080048) found the treatment to be safe and well tolerated.
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Additionally, results from the trial found that those in the high-dose SOR102 group achieved statistically significant separation from placebo across multiple clinical endpoints, including higher marks in the Mayo Score clinical response system for UC. Full results from the will be presented at the upcoming 20th Congress of the European Crohn’s and Colitis Organisation in Berlin.
Ciara Kennedy, chief executive officer of Sorriso Pharmaceuticals, said: “Our Phase Ib results with SOR102 mark a significant milestone for Sorriso Pharmaceuticals and the field of autoimmune therapeutics.
“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 UC. We are excited to advance SOR102 into Phase II development.”
The randomised double-blind, placebo-controlled trial enrolled 22 healthy volunteers and UC patients across two sites, receiving either one of two doses of the drug or placebo over six weeks. The study’s primary endpoint was its safety and tolerability but additional exploratory endpoints also saw some success. Besides the Mayo Score assessment, results reported that the trial saw UC patients achieving symptomatic remission.
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By GlobalDataNow, the company has announced that it plans to push ahead to Phase II trials in 2025 evaluating SOR102 in a larger patient population.
Carlos Sattler, Chief Medical Officer of Sorriso Pharmaceuticals, said: “UC 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.
“These results, observed after just six weeks of treatment, compare favourably 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.”
Elsewhere in the market of UC, Sanofi and Teva Pharmaceuticals have reported that the Phase IIb RELIEVE UCCD study of the human IgG1-λ2 monoclonal antibody targeting TL1A, duvakitug, met its primary endpoints. Meanwhile, Johnson & Johnson (J&J) and Eli Lilly have both revealed the efficacy of their interleukin-23 (IL-23) inhibitors to treat Crohn’s disease.
