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First-in-human study to evaluate safety, tolerability of therapy for ulcerative colitis
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OSE Immunotherapeutics has received authorization to initiate a phase 1 clinical trial of OSE-127, a monoclonal antibody targeting the IL-7 receptor with a novel mechanism of action, for the treatment of ulcerative colitis, according to a company press release.
“Initiating this phase 1 study represents a leap forward for OSE-127,” Alexis Peyroles, CEO of OSE Immunotherapeutics, said in the release. “On the heels of publishing the unique mechanism of action of OSE-127 in Nature Communications, we believe even more strongly that this asset has significant potential therapeutic value for treatment of autoimmune diseases and chronic inflammation.”
The first-in-human dose-escalation study will aim to evaluate the safety and tolerability of single- and multiple-ascending intravenous and subcutaneous doses of OSE-127, according to the release.
The randomized, double-blind, placebo-controlled phase 1 trial is expected to comprise 63 healthy volunteers.