OSE-127, a humanized monoclonal antibody, is an antagonist of the IL7 receptor (IL7-R) present on T effector cells, the CD127 receptor, thus down regulating the immune activity.
Interleukin-7 (IL7) is a cytokine that controls the proliferation, apoptosis and activation of CD4 and CD8 effector T-cells in humans.
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 ongoing 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
- A Phase 2 study ongoing in Ulcerative Colitis
- And a Phase 2 study planned in Sjögren’s Syndrome to start shortly
The Phase 1 study of OSE-127 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.
The Phase 1 showed 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 helped determine the dosing and administration schedule for the two independant Phase 2 trials planned with OSE-127:
- In Ulcerative Colitis (OSE Immunotherapeutics sponsor) : in December 2020, the first patient has been enrolled in the randomized, double-blind Phase 2 clinical trial aiming at assessing the efficacy and the safety of OSE-127/S95011 versus placebo in patients with moderate to severe active ulcerative colitis who have previously failed or lost response or are intolerant to previous treatment(s).
- In Sjögren’s Syndrome (Servier sponsor): a Phase 2 trial is planned to start shortly in this indication.