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DiaMedica Therapeutics Announces Regulatory Approval to Begin Phase 2 Trial of DM199 in the Treatment of Preeclampsia
Dosing first participant expected in the fourth quarter of 2024 with preliminary proof-of-concept results targeted for the first half of 2025
About this update from Diamedica Therapeutics Inc.
[{"type":"text","content":"\n\nDosing first participant expected in the fourth quarter of 2024 with preliminary proof-of-concept results targeted for the first half of 2025\n\n\n MINNEAPOLIS--(BUSINESS WIRE)--\nDiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for severe ischemic diseases, today 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.\n\n“We are excited to receive regulatory approval and are eager to advance our Phase 2 clinical trial of DM199 for preeclampsia.” said Rick Pauls, President and Chief Executive Officer of DiaMedica. “This trial marks a significant milestone in our efforts to develop the first therapeutic option for this serious unmet medical need.”\n\nDr. Lorianne Masuoka, Chief Medical Officer of DiaMedica, added, “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. The data anticipated from Part 1a 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.”\n\nAbout Preeclampsia\n\nPreeclampsia 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 ...