Sorriso Announces Data Publication in Lancet Gastroenterology & Hepatology and Presentation of New Findings at UEG 2025

First-in-class Oral Dual Acting Therapy SOR102 Demonstrates Promising Safety, Pharmacokinetics, and Efficacy in Ulcerative Colitis Patients

SALT LAKE, UT, UNITED STATES, November 13, 2025 /EINPresswire.com/ -- Sorriso Pharmaceuticals, a biopharmaceutical company developing novel orally dosed antibodies for immune-mediated disease, today announced the publication of data from its first-in-human Phase 1 trial of SOR102 in The Lancet Gastroenterology and Hepatology. The article, titled “Safety and Pharmacokinetics of SOR102, an Oral Bispecific Inhibitor of Tumour Necrosis Factor-α and Interleukin-23 in Healthy Participants and Patients with Ulcerative Colitis: A First-in-Human, Randomised, Double-Blind, Placebo-Controlled, Phase 1 Trial” outlines the promising safety profile, efficacy, and pharmacokinetics of SOR102, a novel oral bispecific inhibitor that simultaneously targets tumor necrosis factor-α (TNF) and interleukin-23 (IL-23), two key mediators in the inflammatory cascade of ulcerative colitis.

The randomized, double-blind, placebo-controlled trial enrolled 42 healthy participants assigned to single ascending doses and multiple doses of SOR102 or placebo, as well as 22 patients with ulcerative colitis who were randomized to receive SOR102 one- or twice-daily, or placebo for 6 weeks. The study assessed safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy.

In addition to the publication, Sorriso also presented new, compelling data at the UEG Week 2025 conference in Berlin. These data demonstrate the ability of SOR102 to deliver potent anti-TNF and anti-IL-23 activity directly to the colonic tissue of ulcerative colitis patients. The presentation titled “Oral Administration of SOR102 Delivers Anti-TNF/IL-23 Activity Directly to Colonic Tissue and Drives Clinical and Pharmacodynamic Responses in Ulcerative Colitis Patients” was presented by Professor Vipul Jairath from the Department of Medicine, Division of Gastroenterology at Western University, Ontario, Canada in the session titled “New horizons in ulcerative colitis therapies.”

“The results published in The Lancet GI and the new data presented at UEG Week highlight a compelling case for SOR102 as a safe and effective dual acting oral treatment for ulcerative colitis,” said Dr. Jairath. “The data demonstrate safety and tolerability, but also clinically meaningful impact on rigorous endpoints with minimal systemic exposure. It’s an exciting step forward for patients and for the future of inflammatory bowel disease treatment.”

Key Highlights:

• Mechanism of action: SOR102 is comprised of two protease resistant single domain antibodies that are connected by a trypsin-cleavable linker. SOR102 can bind and neutralize TNF and IL-23 while intact or after in vivo trypsin cleavage into SOR102-TNF and SOR102-IL-23 monomers.

• Safety and Tolerability: SOR102 was dosed orally and was safe and well-tolerated in both healthy participants and UC patients. No unexpected adverse events were observed.

• Pharmacokinetics: Serum and urine analysis showed mostly unquantifiable concentrations of SOR102, SOR102-TNF, or SOR102-IL-23 in both healthy participants and patients with UC at any dose of SOR102, supporting limited systemic exposure to SOR102. High and sustained levels of active SOR102 monomers were detected in fecal samples, confirming efficient cleavage by trypsin and maintenance of cytokine-binding activity throughout the GI tract after oral dosing.

• Clinical Efficacy: Higher rates of Mayo Score and modified Mayo Score clinical response, symptomatic remission, and endoscopic improvement were observed in the SOR102 twice-daily treatment group compared to placebo. In addition, a greater reduction in the UC-100 index was also observed in the SOR102 twice-daily treatment group compared to placebo. The UC-100 index was developed to address the need for a more sensitive measure of treatment efficacy in early phase proof-of-concept and dose-finding trials, and is a continuous instrument that combines clinical, endoscopic and histologic sub-scores (Jairath et al. 2019).

• Colonic Tissue Penetration and Biologic Evidence of Target Engagement: Biopsy samples showed high levels of SOR102 monomers in colonic tissue, especially in patients receiving twice-daily dosing. Treatment with SOR102 led to reductions in proinflammatory cytokines (IL-1β, IL-6, TNF-α) and Th1/17 cytokines (IFN-γ, IL-17A, IL-10) in colonic tissue compared to placebo. In SOR102-treated groups, colonic tissue gene expression modules associated with inflammatory immune cell types were significantly reduced compared to placebo, whereas modules representing tissue regenerative pathways were upregulated with SOR102 twice-daily treatment (UEGW_2025 Poster).

Collectively, these results showed that oral SOR102, administered twice daily for six weeks, demonstrated strong and consistent activity across multiple clinical and pharmacodynamic endpoints. The data support the hypothesis that SOR102 targets colonic inflammation directly within tissue, minimizing systemic exposure, which may offer a safer and more effective treatment approach in an orally dosed therapeutic.

“To our knowledge, SOR102 is the is the first oral antibody therapeutic to demonstrate clinical efficacy with GI tissue penetration and compelling evidence of target engagement through cytokine protein and gene expression modulation. We are looking forward to advancing SOR102 into a Phase 2 clinical study for moderate to severe ulcerative colitis” said Dr. Jackie Benson, Chief Scientific Officer of Sorriso Pharmaceuticals.

About Sorriso Pharmaceuticals

Sorriso Pharmaceuticals is a biopharmaceutical company advancing a pipeline of disease-modifying antibodies for the treatment of immune-mediated diseases, including ulcerative colitis and Crohn’s disease. The Sorriso platform generates potent antibodies that can be delivered orally and are designed to maintain activity throughout human intestinal tissue.

For more information, please visit www.sorrisopharma.com.

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Carolyn Coglianese
Sorriso Pharmaceuticals
ccoglianese@sorrisopharma.com

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