DiaMedica Therapeutics has received Health Canada clearance for its clinical trial application to begin a Phase II study assessing DM199 in women with early-onset preeclampsia.
The trial marks a regulatory milestone for the company, which intends to expand the study to the UK and the US as further clearances are secured.
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The dose-ranging, Phase II open-label trial will assess subcutaneous administration of DM199 every three days in pregnant women diagnosed with early-onset PE between 24- and 32-weeks’ gestation.
It will assess the tolerability, safety, and explore early efficacy markers such as changes in placental growth factor (PGIF), sFlt-1, uterine artery pulsatility index, as well as other relevant biomarkers.
Additional endpoints include maternal and foetal complications and gestational age at delivery. Three dose levels of DM199 will be tested. Recruitment is expected to begin later this year.
DM199 is a recombinant form of human tissue kallikrein-1 protein (rhKLK1), under development not only for preeclampsia but also for foetal growth restriction and acute ischaemic stroke.
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By GlobalDataDiaMedica Therapeutics president and CEO Rick Pauls said: “Health Canada’s authorisation to initiate our Phase II clinical trial of DM199 in preeclampsia represents an important regulatory milestone for DiaMedica. 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.
“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 October 2024, DiaMedica received approval from the South African Health Products Regulatory Authority to commence a Phase II clinical trial of DM199 to treat preeclampsia.
