DiaMedica Therapeutics has secured approval from the South African Health Products Regulatory Authority (SAHPRA) to initiate a Phase II clinical trial evaluating DM199, a recombinant serine protease, for the treatment of preeclampsia. This regulatory milestone allows DiaMedica to proceed with its two-part study at Tygerberg Hospital in Cape Town, South Africa, marking a significant step in addressing this serious pregnancy disorder.
Trial Design and Objectives
The open-label, single-center, single-arm trial is designed to assess the safety and pharmacodynamics of DM199 in women diagnosed with preeclampsia. The trial aims to enroll up to 90 women with preeclampsia and potentially 30 subjects with fetal growth restriction. Researchers will investigate whether DM199 can safely reduce maternal blood pressure and dilate intrauterine arteries, thereby enhancing placental blood flow.
DiaMedica anticipates commencing subject dosing in the fourth quarter of 2024, with top-line results from Part 1a of the trial expected in the first half of the following year. Prior to this, DiaMedica obtained approval from the Health Research Ethics Committee at Stellenbosch University in June.
Preeclampsia and DM199's Potential
Preeclampsia, a severe pregnancy disorder, typically manifests after the 20th week of gestation and is characterized by elevated blood pressure and potential organ damage, often affecting the kidneys and liver. Current treatments primarily focus on managing symptoms and preventing complications, with limited options to address the underlying causes.
DiaMedica's Chief Medical Officer, Dr. Lorianne Masuoka, stated, "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."
Dr. Masuoka added, "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."
Background on DM199
DM199 is a recombinant form of human tissue kallikrein-1 (KLK1), a serine protease that regulates various physiological processes, including blood pressure, inflammation, and angiogenesis. By targeting KLK1, DM199 aims to improve placental perfusion, reduce maternal blood pressure, and promote healthier endothelial function, potentially addressing the underlying pathophysiology of preeclampsia.
It is worth noting that 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.
