OSE Immunotherapeutics Announces Positive Results from Antagonist OSE-127 Study

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 as a full-antagonist of the CD127 receptor, the alpha chain of the interleukin-7 receptor (IL-7R). OSE-127 has been shown in previous studies to induce a powerful antagonistic effect on effector T lymphocytes responsible for causing autoimmune diseases.

The Phase 1 study results show a good safety and tolerability profile for OSE-127. All pharmacokinetic and pharmacodynamic parameters are consistent and demonstrate a dose-proportionality across the several dose-levels up to 10 mg/kg. These findings will help determine the dosing and administration schedule for the two planned Phase 2 trials in ulcerative colitis and Sjögren’s syndrome. Both trial initiations are expected in 2020.

"These encouraging Phase 1 findings, together with the novel and differentiated mechanism of action of OSE-127, the only full-antagonist of IL-7R, provide a firm foundation for further clinical development. These data support the potential of this compound to be a relevant therapy in ulcerative colitis, a chronic inflammatory bowel disease, representing 12.2 per 100,000 people by year* and Sjögren's syndrome, representing 7 per 100,000 people by year. We look forward to evaluating the product’s efficacy in both indications through two independent Phase 2 studies expected to be initiated in 2020," said Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics.

This study was a first-in-human dose-escalation, randomized, double-blind, placebo-controlled Phase 1 trial, aimed to evaluate the safety and tolerability of single- and multiple-ascending intravenous and subcutaneous doses of OSE-127 in 63 healthy volunteers. Secondary endpoints included measures of pharmacokinetics, pharmacodynamics and immunogenicity to help assess and understand how the drug is absorbed and metabolized.

OSE-127 is being developed in partnership with Servier¹ under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases. In parallel, Servier plans to develop OSE-127 in Sjögren’s syndrome.

OSE-127 is a monoclonal immunomodulatory antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor (IL-7R) that induces a powerful antagonist effect on effector T lymphocytes. Interleukin-7 is a cytokine which specifically regulates the tissue migration of human effector T lymphocytes, especially in the gut. The blockage of IL-7R prevents the migration of pathogenic T lymphocytes while preserving regulator T lymphocytes which have a positive impact in autoimmune diseases.

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