DiaMedica received a No Objection Letter from Health Canada for its Clinical Trial Application, enabling the initiation of an open-label Phase 2 trial of DM199 in pregnant women with early-onset preeclampsia between 24 and 32 weeks of gestation. This regulatory milestone follows encouraging safety and efficacy signals from an investigator-sponsored study in South Africa.

The dose-ranging trial will administer three subcutaneous dose levels of DM199 every three days until delivery, evaluating safety, tolerability and exploratory efficacy markers. Primary endpoints include changes in uterine artery pulsatility index and levels of sFlt-1, placental growth factor and other preeclampsia-associated biomarkers.

DiaMedica plans to start the Canadian trial in 2026 and, upon securing additional approvals, expand the study into the United States and United Kingdom. These markets represent key regulatory jurisdictions for potential global development and commercialization of DM199.

DM199 is a recombinant form of human tissue kallikrein-1 designed to enhance nitric oxide and prostacyclin production, improving arterial health and microcirculatory blood flow. No approved treatments currently exist for early-onset preeclampsia, highlighting the unmet medical need that DM199 aims to address.