IDMC recommends that Phase III SALAMANDER trial of REX 001 continues in chronic limb-threatening ischemia.

Following assessment of the interim efficacy and safety data, the independent Data Monitoring Committee (DMC) recommended continuation of the trial unchanged.

Following unblinded prespecified statistical analysis of safety and efficacy results from the first 30% of enrolled patients, the DMC recommended continuation of the study as planned in the protocol, confirming that the expected effect of REX 001 compared to placebo in the trial is on track and that the benefit-risk was acceptable. There were no significant safety concerns. This positive interim analysis supports the hypothesis that REX 001 is an effective and safe treatment for CLTI and is consistent with the effect observed in previous clinical trials, where treatment with REX-001 resulted in complete ulcer healing in over 70% of patients.

The Phase III trial with REX 001 includes two planned interim analyses after 30% and 50% of patients enrolled have reached the 12-month follow-up visit. 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 SALAMANDER trial follows previous clinical trials including a Phase II randomized controlled trial where complete ulcer healing occurred in 75% of treated patients (compared to 14% healing in the control group). The SALAMANDER 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.