Jasper Therapeutics announced that its investigational new drug application for a Phase 1b/2a repeat dose clinical study of subcutaneous briquilimab in the treatment of CSU has been cleared by the U.S. Food and Drug Administration. The Phase 1b/2a study in CSU is a dose escalation study evaluating repeat doses of subcutaneous briquilimab in adult CSU patients who remain symptomatic after treatment with, or who cannot tolerate omalizumab. The study is expected to enroll approximately 40 patients across 6 cohorts and the primary endpoints will be safety and tolerability of briquilimab with secondary endpoints focused on efficacy measures and pharmacokinetics. The study will be conducted at sites in the US and EU and Jasper is expecting to enroll the first patient by the end of 2023 and to be able to report data from early cohorts by mid-2024.
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