OSE Immunotherapies’ UC drug gets DSMB positive recommendation
James Spargo | July 6, 2023 | News story | Research and Development | EMA, Gastrointestinal tract, OSE Immunotherapeutics, ulcerative colitis
French biotech company OSE Immunotherapeutics has announced that its Ulcerative Colitis (UC) trial’s Independent Drug Safety Monitoring Board (DSMB) has provided a positive recommendation to continue the phase 2 trial of IL-7 Receptor (IL-7R) antagonist lusvertikimab (OSE-127) until completion.
The ongoing phase 2 trial is evaluating the safety and efficacy of lusvertikimab versus placebo in patients with moderate to severe active UC who failed, lost response to or were intolerant to previous treatments. A positive analysis was seen in the prespecified first 50 patients (a third of the total enrolment) after having completed the induction phase. The major milestone is expected in the next few months with the top-line results after the induction phase (primary endpoint at week 10). The first early assessment in maintenance after six months of therapy is expected in 2024.
Lusvertikimab has also been provided a positive opinion on Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for the treatment of Acute Lymphoblastic Leukaemia (ALL).
Nicolas Poirier, CEO of OSE Immunotherapeutics, commented: “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 UC phase 2 study with 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 ODD from the EMA. Lusvertikimab orphan status for the treatment of 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.”
James Spargo
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