DiaMedica gets regulatory clearance from Health Canada for phase 2 preeclampsia study
Lucy Batizovsky | March 11, 2026 | News story | Research and Development | DiaMedica, Health Canada, preeclampsia
DiaMedica Therapeutics has received a No Objection Letter (NOL) from Health Canada, giving the company regulatory clearance to start its phase 2 study of novel biologic DM199 (rinvecalinase alfa) in patients with early-onset preeclampsia (PE). The trial will start in 2026 and expand into the US and UK as regulatory clearances are obtained.
Rick Pauls, President and CEO of DiaMedica Therapeutics, said: “This clearance allows us to launch our planned phase 2 PE study to build upon the encouraging results observed in the investigator-sponsored trial in South Africa.
“We look forward to continuing our work to bring a clinically meaningful therapeutic option for women suffering from early-onset preeclampsia, a patient population with significant unmet medical need and no currently approved treatment options.”
In the study, DM199’s safety, tolerability and efficacy, including changes in uterine artery pulsatility index, sFlt-1, placental growth factor (PGIF) and other biomarkers associated with preeclampsia, maternal and fetal complications and gestational age at delivery, will be evaluated as a treatment for pregnant women diagnosed with early-onset preeclampsia between 24 and 32 weeks of gestation. An initial three dose levels of DM199 will be administered subcutaneously every three days until delivery.
DM199 is a recombinant form of the human tissue kallikrein-1 protein (rhKLK1), currently in clinical development for preeclampsia, fetal growth restriction and acute ischemic stroke.
DiaMedica is a clinical stage biopharmaceutical company focused on improving the lives as people suffering from serious ischaemic diseases.
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