Interleukin-7 (IL7) is a cytokine that controls the proliferation, apoptosis and activation of CD4 and CD8 effector T-cells in humans.
OSE-127, a humanized monoclonal antibody, is an antagonist of the IL7 receptor (IL7R) present on T effector cells, the CD127 receptor, thus down regulating the immune activity.
OSE-127 is under an option license agreement signed with Servier in December 2016 to be developed up to the completion of a phase 2 clinical trial planned in ulcerative colitis, an autoimmune bowel disease; in parallel, OSE-127 will be developed in Sjögren’s syndrome, the second most frequent auto-immune disease.
ABOUT THE OSE-127 CLINICAL PROGRAM
- Positive Results from Phase 1 Clinical Study
- Planned Phase 2 Studies in Ulcerative Colitis and Sjögren’s Syndrome to Start in 2020
The Phase 1 study of OSE-127, conducted in Belgium, was initiated in November 2018 and completed in Q4 2019. 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 (OSE Immunotherapeutics sponsor) and Sjögren’s syndrome (Servier sponsor). Both trial initiations are expected in 2020.
This Phase 1 study 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.