Selecta Biosciences announced the initiation of a six month head-to-head clinical trial, designed to evaluate superiority of its lead product candidate, SEL-212, compared to Krystexxa, the current FDA-approved uricase therapy in adult patients with chronic refractory gout. The COMPARE trial is expected to enroll between 100 and 150 patients and is designed to compare the efficacy and safety of SEL-212 to Krystexxa in adult patients with chronic refractory gout. The primary endpoint is expected to be the maintenance of serum uric acid levels of less than 6mg/dL at six months. An interim six-month data readout is projected inQ4 with a full statistical superiority data analysis readout expected in Q1 of 2020. The results of the COMPARE trial are expected to inform the design of the planned Phase 3 clinical trial of SEL-212, which the company plans to initiate in Q4.
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