Servier and OSE Immunotherapeutics announce completion of patient enrollment in the Phase 2a clinical trial of OSE-127/S95011 in primary Sjögren’s syndrome

Servier and OSE Immunotherapeutics announce completion of patient enrollment in the Phase 2a clinical trial of OSE-127/S95011 in primary Sjögren’s syndrome

Paris and Nantes (France), November 3, 2022, 7:30AM CET - Global pharmaceutical group Servier and French biotechnology company OSE Immunotherapeutics SA today announced the completion of patient enrollment in the Phase 2a clinical trial evaluating the efficacy and safety of monoclonal antibody OSE-127/S95011 in primary Sjögren’s syndrome.

This international, randomized, double-blind, placebo-controlled, Phase 2a study is designed to evaluate the efficacy and tolerance of the monoclonal antibody named OSE-127/S95011 in primary Sjögren’s syndrome. The study includes 48 patients across a score of centers located in the United States, Australia and Europe. Results are expected in 2023.

Patricia Belissa-Mathiot, Servier's Director of clinical development and R&D Chief Medical Officer, said: "We are humbled with the progress of this clinical study and look forward to announcing the initial results in the coming year. Primary Sjögren’s syndrome, one of the most common systemic autoimmune diseases, is a disease with significant unmet need and we are grateful to the patients for their participation in this study."

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics said: “We are thankful for our partnership with Servier as we continue to progress this Phase 2a clinical trial, which represents an important step forward in determining the clinical safety and efficacy of OSE-127/S95011 for patients living with Sjögren’s syndrome.”

OSE-127/S95011, for which Servier has worldwide rights, is being developed in partnership between OSE Immunotherapeutics and Servier via a collaboration agreement, with the possibility for Servier to exercise a licensing option. Two clinical studies evaluating OSE-127/S95011 are ongoing: a Phase 2a study conducted by Servier in primary Sjögren’s syndrome and a Phase 2 study conducted by OSE Immunotherapeutics in ulcerative colitis.

About Sjögren’s syndrome

Primary Sjögren’s syndrome is an autoimmune disease characterized by lymphocytic infiltration of salivary and lacrimal glands, causing dryness of mouth and eyes and negatively impacting quality of life. Other organs can be affected. Primary Sjögren’s syndrome is one of the most common chronic systemic autoimmune diseases, with a prevalence of 60.82 per 100,000 population[1] according to an epidemiological meta-analysis of primary Sjögren’s syndrome.

[1] Source: https://ard.bmj.com/content/74/11/1983#