DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing innovative treatments for severe ischemic diseases, today announced that the first patient has been dosed in its investigator-sponsored Phase 2 trial of DM199 for preeclampsia (PE). The company expects to report top-line data from Part 1A of the trial in the first half of 2025, which will provide initial proof-of-concept, including an assessment of DM199’s safety and its potential to lower blood pressure. For patients with early-onset PE, DiaMedica will also evaluate whether DM199 improves uterine artery dilation, suggesting the therapy could have disease-modifying effects in this subgroup.
DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel therapies for severe ischemic diseases, has announced the dosing of the first patient in its investigator-sponsored Phase 2 trial of DM199 for the treatment of preeclampsia (PE).
“We are thrilled to reach this important milestone,” said Rick Pauls, President and CEO of DiaMedica Therapeutics. “Preeclampsia is a serious condition, and this trial represents a significant step forward in our efforts to improve maternal and fetal health. We are eager to explore DM199’s potential to provide a much-needed therapy for those affected by this life-threatening condition.”
Dr. Lorianne Masuoka, Chief Medical Officer of DiaMedica, added, “This moment reflects significant progress in our mission to provide a safe and effective treatment for preeclampsia. It is a testament to our team’s dedication and commitment, and we remain focused on achieving our clinical goals.”
About Preeclampsia
Preeclampsia is a severe pregnancy disorder that typically occurs after the 20th week of gestation, characterized by high blood pressure and damage to vital organs, particularly the kidneys and liver. Affecting up to 8% of pregnancies worldwide, preeclampsia poses serious risks to both mother and child, including stroke, placental abruption, progression to eclampsia, premature delivery, and even death. Symptoms can include severe headaches, vision changes, abdominal pain, and swelling in the hands and face.
Currently, the only way to stop the progression of preeclampsia is to deliver the baby, often prematurely. Women who have experienced preeclampsia face higher long-term risks of developing hypertension, heart disease, and stroke. Notably, there are no approved therapeutics for preeclampsia in the United States or Europe.
About the Preeclampsia Phase 2 Trial
The Phase 2 trial is an open-label, single-center, single-arm, safety and pharmacodynamics, proof-of-concept study evaluating DM199 in treating preeclampsia. Conducted at Tygerberg Hospital in Cape Town, South Africa, under the leadership of Dr. Catherine Cluver, Professor of Maternal/Fetal Medicine at Stellenbosch University, the study will enroll up to 90 women with preeclampsia, including potentially 30 subjects with fetal growth restriction.
Top-line data from Part 1A of the trial are expected in the first half of 2025 and will assess DM199’s safety and its ability to lower maternal blood pressure. Additionally, in patients with early-onset PE, the study will evaluate whether DM199 improves uterine artery dilation, which could suggest the therapy has disease-modifying effects.
About DM199
DM199 (rinvecalinase alfa) is a recombinant form of human tissue kallikrein-1 (rhKLK1) currently being developed for acute ischemic stroke (AIS) and preeclampsia. KLK1 is a serine protease enzyme that plays a critical role in regulating several physiological processes by increasing the production of nitric oxide, prostacyclin, and endothelium-derived hyperpolarizing factors. In preeclampsia, DM199 is designed to lower blood pressure, improve endothelial function, and enhance blood flow to maternal organs and the placenta.
For acute ischemic stroke, DM199 aims to restore blood flow and support neuronal survival by dilating blood vessels around the ischemic area, inhibiting neuronal cell death, and promoting angiogenesis to aid in neuronal remodeling.
About DiaMedica Therapeutics Inc.
DiaMedica Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on improving the lives of patients with serious ischemic diseases, with a particular emphasis on acute ischemic stroke and preeclampsia. The company’s lead candidate, DM199, is the first recombinant form of KLK1, an established therapeutic in Asia for treating acute ischemic stroke, preeclampsia, and other vascular diseases.
