Ixaka (formerly Rexgenero) reported positive interim results from a phase 3 trial of its lead drug candidate, REX-001, evaluating REX-001 versus placebo in patients diagnosed with chronic limb-threatening ischemia (CLTI) and diabetes. Following unblinded prespecified statistical analysis of safety and efficacy results from the first 30% of enrolled patients evaluated 12 months after treatment, the data monitoring committee (DMC) recommended continuation of the study as planned. There were no significant safety concerns. Ixaka remains blinded to the data until the completion of the trial.
The SALAMANDER trial is a randomized double-blind placebo-controlled adaptive trial including diabetic patients with Rutherford category 5 CLTI and with complete ulcer healing as the primary endpoint. The trial is actively recruiting in multiple sites in Europe, including sites in the UK, Spain, Austria, Portugal, Poland, Hungary, the Netherlands, the Czech Republic, Latvia, Lithuania and Georgia.
In previous clinical trials, including a Phase 2 randomized controlled trial, complete ulcer healing occurred in 75% of treated patients (compared to 14% healing in the control group).
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