DiaMedica Receives Health Canada Approval for Phase II Preeclampsia Trial of DM199
Key Insights
DiaMedica Therapeutics (search) has received Health Canada clearance to begin a Phase II study of DM199 in women with early-onset preeclampsia (search), marking an important regulatory milestone for the company.
The dose-ranging trial will assess subcutaneous administration of DM199 every three days in pregnant women diagnosed with early-onset preeclampsia (search) between 24- and 32-weeks' gestation.
DM199 is a recombinant form of human tissue kallikrein-1 protein (search) being developed for preeclampsia (search), a condition with significant unmet medical need and no currently approved treatment options.
DiaMedica Therapeutics (search) has received Health Canada clearance for its clinical trial application to begin a Phase II study assessing DM199 in women with early-onset preeclampsia (search). The regulatory approval represents a significant milestone for the biotechnology company, which plans to expand the study internationally as additional clearances are obtained.
Trial Design and Patient Population
The dose-ranging, Phase II open-label trial will evaluate subcutaneous administration of DM199 every three days in pregnant women diagnosed with early-onset preeclampsia (search) between 24- and 32-weeks' gestation. Three dose levels of DM199 will be tested, with recruitment expected to begin later this year.
The study will assess tolerability and safety while exploring early efficacy markers including changes in placental growth factor (search) (PGIF (search)), sFlt-1 (search), and uterine artery pulsatility index, along with other relevant biomarkers. Additional endpoints include maternal and fetal complications and gestational age at delivery.
Therapeutic Mechanism and Development Pipeline
DM199 is a recombinant form of human tissue kallikrein-1 protein (search) (rhKLK1 (search)) under development not only for preeclampsia (search) but also for fetal growth restriction (search) and acute ischemic stroke (search). The therapeutic approach targets a patient population with significant unmet medical need, as there are currently no approved treatment options for early-onset preeclampsia (search).
Regulatory Progress and Future Plans
DiaMedica intends to expand the study to the UK and the US as further regulatory clearances are secured. The company previously received approval from the South African Health Products Regulatory Authority in October 2024 to commence a Phase II clinical trial of DM199 for preeclampsia (search) treatment.
"Health Canada's authorisation to initiate our Phase II clinical trial of DM199 in preeclampsia (search) represents an important regulatory milestone for DiaMedica," said Rick Pauls, president and CEO of DiaMedica Therapeutics (search). "This clearance allows us to launch our planned Phase II PE study to build upon the encouraging results observed in the investigator-sponsored trial in South Africa."
Pauls emphasized the company's commitment to addressing the unmet medical need, stating: "We look forward to continuing our work to bring a clinically meaningful therapeutic option for women suffering from early-onset preeclampsia (search), a patient population with significant unmet medical need and no currently approved treatment options."