DiaMedica Therapeutics Inc., a clinical-stage biopharmaceutical company, has initiated its Phase 2 investigator-sponsored trial for DM199, a potential preeclampsia (PE) treatment. The company anticipates initial results in the first half of 2025. This part of the study aims to establish DM199’s safety profile and ability to reduce blood pressure. For patients experiencing early-onset PE, researchers will also investigate potential improvements in uterine artery dilation, suggesting the therapy might modify the disease’s course.
Preeclampsia, a severe pregnancy complication typically arising after 20 weeks of gestation, is characterized by high blood pressure and organ damage, often affecting the kidneys and liver. Globally, it impacts up to 8% of pregnancies, creating substantial risks for both mother and baby. These risks encompass stroke, placental abruption, progression to eclampsia (seizures), premature birth, and even death. Symptoms can include severe headaches, vision changes, upper abdominal pain, and swelling in the hands and face. Currently, the only intervention to halt preeclampsia’s progression is delivering the baby, often prematurely. Women with a history of preeclampsia face a significantly elevated risk of future hypertension, heart disease, and stroke. Currently, no approved treatments exist for preeclampsia in the United States or Europe.
The Phase 2 trial, an open-label, single-center, single-arm study, will assess the safety and pharmacodynamics of DM199 in treating preeclampsia. Conducted at Tygerberg Hospital in Cape Town, South Africa, it is led by Professor Catherine Cluver of Stellenbosch University in partnership with DiaMedica. The trial aims to enroll up to 90 women with preeclampsia and potentially 30 with fetal growth restriction. In addition to blood pressure reduction, researchers will examine whether DM199 improves uterine artery dilation in early-onset PE patients. Such an outcome could indicate DM199’s potential as a disease-modifying therapy.
DM199 (rinvecalinase alfa) is a recombinant form of human tissue kallikrein-1 (rhKLK1), also under investigation for acute ischemic stroke. KLK1, a serine protease enzyme, is crucial in regulating physiological processes by increasing the production of nitric oxide, prostacyclin, and endothelium-derived hyperpolarizing factors. In preeclampsia, DM199 is expected to lower blood pressure, improve endothelial health, and enhance blood flow to maternal organs and the placenta. For acute ischemic stroke, DM199 is designed to increase blood flow and neuronal survival around the blocked blood vessel, inhibiting neuronal cell death and promoting blood vessel formation for neuronal repair. DiaMedica Therapeutics Inc., focused on developing treatments for severe ischemic diseases, believes DM199 offers a promising new approach to addressing these critical conditions.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
