DiaMedica Therapeutics has secured a key regulatory green light in Canada, clearing the way for a new clinical trial targeting one of pregnancy’s most dangerous complications.
The clinical-stage biotech company announced it has received a No Objection Letter from Health Canada for its Clinical Trial Application to test DM199 in a Phase 2 study for early-onset preeclampsia. The decision allows the company to begin enrolling patients in Canada while preparing to expand the trial into the United States and United Kingdom once regulatory approvals are secured.
DiaMedica said it plans to launch the trial later in 2026.
“Health Canada’s authorization to initiate our Phase 2 clinical trial of DM199 in preeclampsia represents an important regulatory milestone for DiaMedica,” said Rick Pauls, President and Chief Executive Officer of DiaMedica Therapeutics.
“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.”
The upcoming Phase 2 trial will be an open-label, dose-ranging study involving pregnant women diagnosed with early-onset preeclampsia between 24 and 32 weeks of gestation. Researchers will assess the safety and tolerability of DM199, while also exploring early signs of effectiveness.
Investigators will monitor a range of indicators linked to preeclampsia, including uterine artery pulsatility index, sFlt-1, placental growth factor (PGIF) and other biomarkers associated with maternal and fetal complications. The study will also track gestational age at delivery.
Participants will receive one of three dose levels of DM199, administered by subcutaneous injection every three days until delivery.
The company said the study will begin in Canada before expanding into the U.S. and U.K. following additional regulatory clearances.
Recent coverage by NPR has highlighted the urgent global need for effective treatments for preeclampsia, a life-threatening pregnancy disorder that currently has no approved therapies. DiaMedica believes DM199 could offer a promising new option if clinical trials prove successful.
