DiaMedica Therapeutics to expand DM199 clinical development program

DiaMedica Therapeutics announced that it plans to expand its DM199, or rhKLK1, clinical development program into preeclampsia. Preeclampsia is a life-threatening pregnancy-associated vascular disorder characterized by new onset hypertension with proteinuria, and/or end organ dysfunction, and poses significant risks to both mother and baby. DM199 has the potential to lower blood pressure, enhance endothelial health, and improve perfusion to maternal organs and the placenta. This mode of action is believed to occur through the increased production of endothelial nitric oxide, prostacyclin, and endothelial-derived hyperpolarizing factors, or EDHFs. These pathways are typically depressed or impaired in preeclampsia. DM199 holds the potential to be disease modifying for preeclampsia patients if it can effectively increase placental perfusion and reduce placental hypoxia, a significant contributor to the pathophysiology of preeclampsia. DM199 has demonstrated blood pressure reductions in multiple prior studies. New results from analysis of overall participants with elevated blood pressure from the DM199 Phase 2 REDUX clinical trial in three types of chronic kidney disease, or CKD, which demonstrated a statistically significant reduction in systolic blood pressure, or SBP, at day 95. DiaMedica has also completed studies on fertility, embryofetal development and pre- and post-natal development in animal models, which support the potential safety in pregnant humans. DiaMedica recently completed a placental transfer study in pregnant rats in which DM199 did not cross the placental barrier. Specifically, DM199 was detectable in the maternal blood, but undetectable in the fetal blood. Up to 90 women with preeclampsia, and potentially 30 subjects with fetal growth restriction, will be evaluated with the first subject anticipated to be enrolled in the fourth quarter of 2024, pending regulatory approval. Part 1A topline study results are anticipated in the first half of 2025, which will demonstrate whether DM199 is safe, lowers blood pressure, and dilates intrauterine arteries to increase placental blood flow. This Phase 2 open-label, single center, single-arm, safety and pharmacodynamic, proof-of-concept, investigator-sponsored study of DM199 in treating preeclampsia will be conducted at the Tygerberg Hospital, Cape Town, South Africa in collaboration with DiaMedica. More details on DM199 for preeclampsia and fetal growth restriction will be presented at a key opinion leader event to be held on July 29. Instructions for participating in this event will be provided in the coming weeks.