newsfilter
← Latest News
Business Wire·

DiaMedica Therapeutics Receives Health Canada Clearance to Initiate Phase 2 Study of DM199 in Preeclampsia

DMAC
  • DiaMedica Therapeutics (NASDAQ: DMAC) received a No Objection Letter from Health Canada to initiate a Phase 2 trial of DM199 for early-onset preeclampsia.
  • The company plans to launch the Phase 2 study in 2026 with subsequent expansion into the United States and United Kingdom upon regulatory clearance.
  • The Phase 2 trial is an open-label, dose-ranging study evaluating safety, tolerability, and exploratory efficacy markers in pregnant women diagnosed between 24 and 32 weeks of gestation.
  • The study will assess three subcutaneous dose levels of DM199 administered every three days until delivery.
  • Recent National Public Radio coverage highlighted the urgent need for new preeclampsia treatments and the potential of DM199 to improve maternal outcomes.
  • DM199 (rinvecalinase alfa) is a recombinant human tissue kallikrein-1 protein designed to increase nitric oxide production, reduce blood pressure, and enhance blood flow in preeclampsia patients.
  • DiaMedica Therapeutics is a clinical-stage biopharmaceutical company focusing on preeclampsia, fetal growth restriction, and acute ischemic stroke.