お知らせ • Oct 09
DiaMedica Therapeutics Inc. Announces Regulatory Approval to Begin Phase 2 Trial of DM199 in the Treatment of Preeclampsia
DiaMedica Therapeutics Inc. announced regulatory approval has been received to initiate a Phase 2 clinical trial with DM199, its proprietary recombinant serine protease, for the treatment of preeclampsia. The South African Health Products Regulatory Authority (SAHPRA) has issued approval to proceed with the planned two-part Phase 2 study, which will be conducted as an investigator-sponsored trial at Tygerberg Hospital in Cape Town, South Africa, under the leadership of Prof. Catherine Cluver, MD, PhD as the principal investigator. DiaMedica previously received approval from the Health Research Ethics Committee at Stellenbosch University on June 26, 2024. The Company anticipates dosing will commence in the fourth quarter of 2024. Top-line results for Part 1a of the study are expected in the first half of 2025. Preeclampsia is a serious pregnancy disorder that typically develops after the 20th week of gestation, characterized by high blood pressure and damage to organ systems, often the kidneys and liver. Affecting up to 8% of pregnancies worldwide, preeclampsia can pose significant risks to both the mother and baby, including risk of stroke, placental abruption, progression to eclampsia, premature delivery and death. Symptoms may include severe headaches, vision changes, upper abdominal pain and swelling in the hands and face. Delivery of the baby, often very prematurely, is the only available option for stopping the progression of preeclampsia. Women who have had preeclampsia have three to four times the risk of high blood pressure and double the risk for heart disease and stroke. There are currently no approved therapeutics for preeclampsia in the United States or Europe. 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 (SA), under the direction of Catherine Cluver, MD, PhD, Professor of Maternal/Fetal Medicine, Stellenbosch University, Stellenbosch, SA, in collaboration with DiaMedica. This trial will enroll up to 90 women with preeclampsia and potentially 30 subjects with fetal growth restriction. Dosing is expected to commence in the fourth quarter of 2024 and Part 1a topline study results are anticipated in the first half of 2025 and are intended to demonstrate whether DM199 is safe, lowers maternal blood pressure and dilates intrauterine arteries to increase placental blood flow. DM199 (rinvecalinase alfa) is a recombinant form of human tissue kallikrein-1 (rhKLK1) in clinical development for acute ischemic stroke and preeclampsia. KLK1 is a serine protease enzyme that plays an important role in the regulation of diverse physiological processes via a molecular mechanism that increases production of nitric oxide, prostacyclin and endothelium-derived hyperpolarizing factor. In preeclampsia, DM199 is intended to lower maternal blood pressure, enhance endothelial health and improve perfusion to maternal organs and the placenta. In the case of acute ischemic stroke, in which DiaMedica is also studying the use of DM199, DM199 is intended to enhance blood flow and boost neuronal survival in the ischemic penumbra by dilating arterioles surrounding the site of the vascular occlusion and inhibition of apoptosis (neuronal cell death) while also facilitating neuronal remodeling through the promotion of angiogenesis.