DiaMedica Therapeutics, a clinical-stage biopharmaceutical company focused on novel treatments for severe ischemic diseases, has announced the initiation of a Phase 2 trial for their preeclampsia treatment, DM199. This announcement came alongside their second quarter 2024 financial results and business update.
Preeclampsia (PE) is a serious pregnancy complication characterized by high blood pressure and damage to organ systems, often affecting the kidneys and liver. Affecting up to 8% of pregnancies globally, PE poses significant risks to both mothers and their babies, including stroke, placental abruption, eclampsia, and premature delivery. Currently, there are no approved therapies for preeclampsia in the United States or Europe, leaving a substantial unmet medical need.
DiaMedica’s DM199 is a recombinant form of human tissue kallikrein-1 (rhKLK1), designed to enhance blood flow and improve endothelial health. Previous studies have demonstrated its potential to lower blood pressure, improve perfusion to maternal organs, and enhance placental blood flow. Notably, a recent study in pregnant rats showed that DM199 did not cross the placental barrier, supporting its potential safety in pregnant humans.
The Phase 2 trial, set to begin in the fourth quarter of 2024, will be an open-label, single-center, single-arm, investigator-sponsored study conducted at Tygerberg Hospital in Cape Town, South Africa. Under the direction of Dr. Catherine Cluver, the study aims to enroll up to 90 women with preeclampsia and potentially an additional 30 subjects with fetal growth restriction.
This trial will evaluate the safety and pharmacodynamics of DM199, with topline results expected in the first half of 2025. The primary objectives include assessing whether DM199 is safe, effectively lowers blood pressure, dilates intrauterine arteries to increase placental blood flow, and impacts relevant biomarkers.
DiaMedica’s recent financial update also revealed a robust financial position. The company completed a $12 million private placement, extending its cash runway into the third quarter of 2026. This financial stability will support ongoing clinical and product development activities, including the pivotal Phase 2/3 ReMEDy2 trial for acute ischemic stroke and the expansion into preeclampsia.
