DM199 (rinvecalinase alfa)

June 23, 2026: DiaMedica Therapeutics Inc. (NASDAQ: DMAC) announced dosing of the first two patients in an investigator-sponsored, open-label, single-arm Phase 2 trial of DM199 (rinvecalinase alfa) for early-onset fetal growth restriction (FGR), marking the first clinical evaluation of DM199 in FGR. The study will test three dose levels and plans to enroll up to 30 women with FGR at 27–32 weeks’ gestation. The primary objective is safety and tolerability; exploratory endpoints include uterine artery vascular resistance, umbilical artery Doppler findings, fetal growth trajectory, birthweight centile, pregnancy prolongation, and DM199 levels in umbilical cord blood at birth.

The release states DM199 is a recombinant human tissue kallikrein-1 (KLK1) designed to improve maternal uterine artery blood flow to the placenta via vasodilatory pathways, and that it has been shown not to cross the placental barrier into fetal circulation.

DiaMedica also released a white paper, “The Potential of DM199 to Treat Fetal Growth Restriction,” authored by maternal-fetal medicine experts Stephen Tong, Susan Walker, and Catherine Cluver.