Stemrim's redasemtide phase 2 stroke trial yields mixed results

Stemrim Inc. (TSE:4599) announced interim analysis results from its global Phase 2b clinical trial of Redasemtide, a Regeneration-Inducing Medicine out-licensed to Shionogi & Co., Ltd (TSE:4507), for the treatment of acute ischemic stroke (AIS). The trial, conducted across 18 countries, evaluates the efficacy and safety of Redasemtide in AIS patients ineligible for endovascular recanalization therapy. Results indicated a continuation of the trial for the Redasemtide (1.5 mg/kg) group but prompted the independent evaluation committee to recommend discontinuing the trial for the Redasemtide (0.75 mg/kg) group. While the 1.5 mg/kg dose was initially selected as the expected efficacious dose, regulatory authorities mandated the inclusion of the 0.75 mg/kg group as well. The outcome of this interim analysis falls within the anticipated range, and with the discontinuation of the lower dose group, the required number of subjects will be reduced. Target number of subjects will be redefined to include an additional cohort, but the overall study duration is not expected to be extended. The company views the results as holding significant importance in the clinical development of this investigational drug for AIS and is very pleased with the outcome. Stemrim confirmed that this development would not affect the company's financial results for the fiscal year ending July 31, 2025.