Sorriso Pharma’s UC treatment hits Phase Ib endpoints

The company revealed its plans to advance to Phase II after its treatment for ulcerative colitis demonstrated positive results compared to the placebo.

Sorriso Pharmaceuticals, a biopharma company based in Utah, has announced that its Phase Ib trial for an oral medication intended for ulcerative colitis (UC) patients achieved its goals. The company is now getting ready for the next stage of development.

Sorriso’s oral biologic therapy, SOR102, aims to block the chemicals TNF⍺ and IL-23(p19), which are associated with inflammatory bowel disease (IBD) and may also play a role in ulcerative colitis (UC). Findings from the company’s Phase Ib trial (NCT06080048) indicated that the treatment is safe and generally well accepted by patients.

Furthermore, the trial results indicated that participants in the high-dose SOR102 group showed a meaningful improvement compared to the placebo group in several clinical measures. This included better scores on the Mayo Score clinical response system for ulcerative colitis. Comprehensive results are set to be shared at the upcoming 20th Congress of the European Crohn’s and Colitis Organisation in Berlin.

Ciara Kennedy, the CEO of Sorriso Pharmaceuticals, stated: “The Phase Ib results we achieved with SOR102 represent an important achievement for Sorriso Pharmaceuticals and for the area of autoimmune treatments.”

"We are confident that SOR102, an innovative oral biologic that targets TNFα and IL-23—two key pathways involved in inflammatory bowel disease—has the potential to revolutionize treatment. The clinical data for SOR102 strongly supports its ability to offer a practical and effective oral treatment solution for individuals with ulcerative colitis. We are eager to progress SOR102 into Phase II trials."

The study was a randomized, double-blind, placebo-controlled trial involving 22 healthy individuals and patients with ulcerative colitis (UC) at two different locations. Participants were given either one of two doses of the medication or a placebo for a period of six weeks. The main goal of the study was to evaluate the safety and tolerability of the drug, although there were also other exploratory goals that showed promising results. In addition to the Mayo Score evaluation, findings indicated that some UC patients experienced a reduction in symptoms during the trial.

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The company has revealed its intention to move forward with Phase II trials in 2025, where they will assess SOR102 in a bigger group of patients.

Carlos Sattler, the Chief Medical Officer at Sorriso Pharmaceuticals, stated, “Ulcerative colitis continues to be a difficult condition to manage, but we've observed encouraging rates of clinical remission with the dual targeting of TNFα and IL-23 through the use of antibodies delivered systemically.”

"The findings from just six weeks of treatment show promising results that stand up well against approved therapies. This highlights SOR102's potential to change the way we treat conditions by focusing on these two important inflammatory pathways, all through an easy-to-take oral medication."

In the field of ulcerative colitis, Sanofi and Teva Pharmaceuticals have announced that their Phase IIb RELIEVE UCCD trial, which involves the human IgG1-λ2 monoclonal antibody known as duvakitug that targets TL1A, successfully achieved its main goals. At the same time, Johnson & Johnson and Eli Lilly have both demonstrated the effectiveness of their interleukin-23 (IL-23) inhibitors for treating Crohn's disease.

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