DiaMedica Therapeutics has received approval from the South African Health Products Regulatory Authority (SAHPRA) to commence a Phase II clinical trial of DM199, a recombinant serine protease, to treat preeclampsia.
The approval allows the company to proceed with the two-part study at Tygerberg Hospital in Cape Town, South Africa.
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This open-label, single-centre, single-arm trial will assess the safety and pharmacodynamics of DM199 in treating preeclampsia.
It aims to enrol up to 90 women with preeclampsia and potentially 30 subjects with foetal growth restriction.
This study will investigate if DM199 can safely lower maternal blood pressure and dilate intrauterine arteries to increase placental blood flow.
DiaMedica is due to commence subject dosing in the trial in the fourth quarter of 2024.
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By GlobalDataTop-line results from the Part 1a portion of the trial are expected in the first half of next year.
DiaMedica had previously secured approval from the Health Research Ethics Committee at Stellenbosch University for the trial in June this year.
A serious pregnancy disorder, preeclampsia develops after the 20th week of gestation.
It is characterised by increased blood pressure and organ damage, often affecting the kidneys and liver.
DiaMedica chief medical officer Dr Lorianne Masuoka said: “We believe that DM199 has the potential to be a disease-modifying therapy for preeclampsia, based on its mechanism of action. Specifically, we believe that DM199 targets and has the potential to improve placental perfusion and enhance fetal growth while also lowering maternal blood pressure and improving endothelial health.
“The data anticipated from Part Ia of the study should provide strong proof of concept for DM199’s potential as a disease-modifying therapy, thereby increasing the likelihood of prolongation of gestational days and a healthier baby and mother.”
In July 2022, the company’s Phase II/III ReMEDy2 clinical trial of DM199 for treating patients with acute ischemic stroke was placed on hold by the US Food and Drug Administration.
