DiaMedica Therapeutics Expands DM199 Program to Preeclampsia

DiaMedica Therapeutics, Inc., a clinical-stage biopharmaceutical company specializing in novel treatments for severe ischemic diseases, has announced plans to extend its DM199 (rinvecalinase alfa) clinical development program to address preeclampsia. Preeclampsia is a dangerous pregnancy-related vascular disorder characterized by new onset hypertension, proteinuria, and/or end organ dysfunction, posing significant risks to both mother and baby. Currently, there are no approved therapies for preeclampsia in the U.S. or Europe.

Rick Pauls, President and CEO of DiaMedica, highlighted that DM199, unlike traditional anti-hypertensive small molecules, is a large protein that does not cross the placental barrier in animals, offering a potential safety advantage in pregnancy disorders. The proposed trial is designed to be cost-efficient, aiming to enroll up to 120 participants with an estimated budget of $1.5 million. The trial seeks to provide robust proof of concept for DM199’s efficacy in treating preeclampsia.

Scientific evidence suggests that DM199 can lower blood pressure, improve endothelial health, and enhance perfusion to maternal organs and the placenta. This is believed to occur through increased production of endothelial nitric oxide, prostacyclin, and endothelial-derived hyperpolarizing factors, pathways often impaired in preeclampsia. If DM199 can effectively enhance placental perfusion and reduce hypoxia, it could potentially modify the course of the disease.

In prior studies, DM199 has shown significant blood pressure reductions. Notably, in the Phase 2 REDUX clinical trial for chronic kidney disease (CKD), participants with elevated blood pressure exhibited statistically significant reductions in systolic blood pressure after 95 days of treatment. Additionally, safety studies in animal models have shown no placental transfer of DM199, supporting its potential safety in pregnant humans.

Professor Stephen Tong of the University of Melbourne expressed optimism about DM199’s potential not only to control blood pressure but also to reverse the severity of preeclampsia by improving blood flow to the placenta.

The planned Phase 2 trial will evaluate up to 90 women with preeclampsia and possibly 30 subjects with fetal growth restriction. The first participant is expected to be enrolled in Q4 2024, pending regulatory approval, with initial topline results anticipated in the first half of 2025. The study will be conducted at Tygerberg Hospital in Cape Town, South Africa, under the direction of Professor Catherine Cluver.

The trial consists of three parts. Part 1 will enroll up to 60 pregnant women with severe preeclampsia. Part 2 will include up to 30 women with preeclampsia managed expectantly to prolong pregnancy safely. Part 3, contingent on results from Part 1, will involve up to 30 women with fetal growth restriction but without preeclampsia. Each part aims to assess safety, efficacy, and other disease-specific outcomes.

The study’s primary investigators include Professor Cluver, Professor Tong, and Dr. Sue Walker of the University of Melbourne. DiaMedica’s Chief Medical Officer, Dr. Lorain Mazurka, emphasized the significance of this investigator-sponsored trial, stating that it allows the company to focus on its other clinical endeavors while exploring DM199’s potential in treating preeclampsia.

DiaMedica is also set to host a key opinion leader event on July 29, 2024, to discuss further details about DM199 for preeclampsia and fetal growth restriction.

Preeclampsia is a serious pregnancy disorder affecting up to 8% of pregnancies worldwide, characterized by high blood pressure and organ damage. It poses significant risks to both mother and baby, including stroke, placental abruption, and premature delivery. The standard treatment is to deliver the baby, often prematurely, to halt disease progression.

DM199, a recombinant form of human tissue kallikrein-1, is in clinical development for acute ischemic stroke and preeclampsia. It aims to lower blood pressure and improve endothelial health and perfusion to maternal organs and the placenta. DiaMedica Therapeutics is committed to advancing treatments for serious ischemic diseases, focusing on acute ischemic stroke and preeclampsia.