Servier, an independent global pharmaceutical group, and OSE Immunotherapeutics, a French biotech, have announced enrollment of the first patient in the Phase 2 clinical trial of OSE127/S95011 in Sjögren’s syndrome, with Servier sponsorship.
This international, randomized, double-blind, placebo-controlled Phase 2 study aims to evaluate the efficacy and safety of OSE-127/S95011 in patients with Sjögren’s syndrome.
Patricia Belissa-Mathiot, Director of Clinical Development and R&D Chief Medical Officer at Servier: “The enrollment of the first patient in this study illustrates the momentum initiated with our partner, OSE Immunotherapeutics, to continue the development of OSE-127/S95011. This drug candidate may be a leading treatment in autoimmune diseases and specifically for patients with Sjögren’s syndrome for whom the current therapeutic alternatives are still limited.”
“We are very pleased with this new milestone for OSE-127/S95011 which, through our partnership with Servier, is now advancing into Phase 2 clinical development in two particularly debilitating autoimmune disease indications, Sjögren’s syndrome and ulcerative colitis” says Alexis Peyroles, CEO of OSE Immunotherapeutics.
Sjögren’s syndrome is an autoimmune disease characterized by lymphoid infiltration of the salivary and lacrimal glands leading to dry mouth and eyes. Sjögren’s syndrome is one of the most common chronic systemic autoimmune diseases, with an incidence of 60.82 per 100,000 people, according to a metaanalysis of epidemiological studies in Sjögren’s syndrome.
OSE-127/S95011 is being developed in partnership with OSE Immunotherapeutics as part of a collaboration agreement with license option upon completion of two Phase 2 clinical studies, and exercise of the option by Servier. An initial Phase 2 study under the sponsorship of OSE Immunotherapeutics is currently underway in ulcerative colitis.
As part of the agreement, two milestone payments are planned in favor of OSE Immunotherapeutics: An initial payment of EUR 5 million upon enrollment of the first patient in the Phase 2a clinical study and, if Servier exercises the option, a EUR 15 million payment upon completion of the two Phase 2 clinical studies.
OSE-127/S95011 is a humanized monoclonal antibody that targets the CD127 receptor, the alpha chain of the interleukin-7 receptor, facilitating a potent antagonistic effect on effector T cells. IL-7 is a cytokine that specifically regulates tissue migration of human effector T lymphocytes, particularly in the digestive tract. Blocking the IL7 receptor slows down the migration of pathogenic T cells while preserving regulatory T cells that are beneficial in autoimmune diseases.