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资讯
diamedica therapeutics宣布获得监管机构批准，开始DM199用于治疗子痫前期的2期试验
• Dosing first participant expected in the fourth quarter of 2024 with preliminary proof-of-concept results targeted for the first half of 2025
DiaMedica 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.
DiaMedica 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.
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