March 5, 2026 — Leads & Copy — DiaMedica Therapeutics Inc. (Nasdaq: DMAC) has received a No Objection Letter (NOL) from Health Canada for its Clinical Trial Application to evaluate DM199 in a Phase 2 trial in patients with early-onset preeclampsia (PE).
The regulatory clearance allows DiaMedica to initiate its Phase 2 study of DM199 in early-onset preeclampsia. The company plans to begin the trial in 2026 and expand into the United States and United Kingdom as regulatory clearances are obtained.
DiaMedica’s President and CEO Rick Pauls said Health Canada’s authorization represents an important regulatory milestone for the company. He added this clearance allows them to launch the Phase 2 PE study to build upon encouraging results observed in the investigator-sponsored trial in South Africa. Pauls also noted the company looks forward to continuing its 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.
The Phase 2 trial is an open-label, dose-ranging study evaluating DM199 as a treatment for pregnant women diagnosed with early-onset preeclampsia between 24 and 32 weeks of gestation. The study will evaluate safety, tolerability and, on an exploratory basis, early markers of efficacy after treatment with DM199.
These markers include 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. The study will initially evaluate three dose levels of DM199 administered subcutaneously every three days until delivery. Expansion into the United States and United Kingdom is planned following regulatory clearances.
DM199 (rinvecalinase alfa) is a recombinant form of the human tissue kallikrein-1 protein (rhKLK1) in clinical development for preeclampsia, fetal growth restriction and acute ischemic stroke. KLK1 is a serine protease enzyme that plays an important role in the regulation of diverse physiological processes via a molecular mechanism that increases production of nitric oxide, prostacyclin and endothelium-derived hyperpolarizing factor.
Collectively, in preeclampsia, these processes are believed to improve arterial health, including the uterine arteries, reduce blood pressure and enhance microcirculatory blood flow and tissue perfusion.
DiaMedica Therapeutics Inc. is focused on developing treatments for preeclampsia, fetal growth restriction and acute ischemic stroke. DiaMedica’s lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in Asia for the treatment of acute ischemic stroke, preeclampsia and other vascular diseases.
Recent NPR coverage highlights the need for new treatments for preeclampsia and the promise of DM199 as a potential therapeutic approach to improve maternal outcomes, if successfully developed and approved.
Source: DiaMedica Therapeutics Inc.
