Dec 02, 2019: OSE Immunotherapeutics announced completion and positive results from the Phase 1 study of OSE-127, a humanized monoclonal antibody with a differentiated mechanism of action and full-antagonist of CD127 receptor, alpha chain of the interleukin-7 receptor (IL-7R).
The Phase 1 study results illustrate a good safety and tolerability profile for OSE-127, that help to determine the dosing and administration schedule for the two planned Phase 2 trials in ulcerative colitis and Sjögren’s syndrome.
This study was a first-in-human dose-escalation, randomized, double-blind, placebo-controlled Phase 1 trial which aimed in order to evaluate the safety and tolerability of single- and multiple-ascending intravenous and subcutaneous doses of OSE-127 in 63 healthy volunteers.
Up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases, OSE-127 is developed in partnership with Servier 1 under an option agreement and also Servier plans to develop OSE127 in Sjögren’s syndrome. https://ose-immuno.com/wp-content/uploads/2019/12/EN_191202_OSE-127-Ph-1.pdf