OSE Immunotherapeutics has received a positive recommendation from the Drug Safety Monitoring Board (DSMB) to continue the Phase II clinical trial of lusvertikimab (OSE-127) for the treatment of ulcerative colitis (UC).
The company will now continue its ongoing study until its completion.
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The study will assess the safety and efficacy of the IL-7 Receptor (IL-7R) antagonist lusvertikimab against placebo in patients with moderate to severe active UC.
Patients who failed or lost response, or were not tolerant to their prior treatments, were enrolled in the study.
In the prespecified first 50 subjects who completed the induction phase, the company observed a positive interim futility analysis.
Top-line results after the induction phase (primary endpoint at week ten) are expected in the following months.
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By GlobalDataResults of maintenance therapy, as a part of early assessment for six months, are anticipated in the first half of next year.
OSE Immunotherapeutics CEO Nicolas Poirier said: “After the planned DSMB review recommendation to continue the study until its completion, the company’s primary and strategic focus remains clinical evaluation of lusvertikimab in this ongoing ulcerative colitis Phase II study with the end of accrual expected in the following months.
“In parallel, based on strong preclinical activity demonstrated by Lusvertikimab using patient’s leukemic samples, we are happy to have received a positive opinion on Orphan Drug Designation from the European Medicines Agency.
“Lusvertikimab orphan status for the treatment of acute lymphoblastic leukaemia (ALL) from B or T cell precursors is opening future potential new indications in ALL, rare diseases with limited treatment options. We warmly thank our academic and clinician partners in Kiel, involved with us in this innovative research programme.”
The programme is conducted in collaboration with the University Medical Center Schleswig-Holstein in Germany.
