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DM199 for Pregnancy Complications

Now Recruiting

Clinical Trials

Clinical Trials

  • Overview
  • Acute Ischemic Stroke
  • Preeclampsia

The Potential of DM199 to Teat Preeclampsia

The Potential of DM199 to Teat Preeclampsia
View Presentation

The Potential of DM199 to Treat Preeclampsia

Current Treatment Options for Preeclampsia

Preeclampsia is the second leading cause of maternal death worldwide1, affecting an estimated 5 - 8% of all pregnancies. In the United States alone, approximately 50,000 severe cases are reported each year. Globally, preeclampsia and related hypertensive disorders contribute to the deaths of about 76,000 pregnant women and 500,000 babies each year.2 Research indicates that over 90% of these fatalities occur in low- and middle-income nations, underscoring the disproportionate impact of preeclampsia on minority communities.3

Currently, there are no FDA-approved treatment options to slow the disease progression of preeclampsia. In the absence of a standardized treatment, care typically involves close monitoring of the mother and, if serious complications develop, early delivery of the baby – regardless of gestational age. Medications like angiotensin converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARBs) are contraindicated in preeclampsia because they have a small molecular size and can cross the placental barrier and negatively impact fetal development. A treatment that safely manages blood pressure and protects against vascular damage would represent a major and potentially life-saving breakthrough.

1. Force UPST. Screening for Preeclampsia: US Preventive Services Task Force Recommendation Statement. JAMA 2017; 317(16): 1661-7.
2. Preeclampsia - preeclampsia and maternal mortality: A global burden. Preeclampsia Foundation - Saving mothers and babies from preeclampsia.
3. Say L, Chou D, Gemmill A, et al. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health 2014; 2(6): e323-33.

Trial Design

[Currently Enrolling]

Part 1 will be an open-label, ascending dose finding study. The trial is recruiting acutely hypertensive women that have been diagnosed with preeclampsia and will be giving birth within the next 72 hours. The DM199 dose will gradually increase in cohorts of three patients, starting with an intravenous loading dose, followed by subcutaneous administration. If the treatment proves safe and an effective dosage is identified, we will advance to Part 2.

Part 2 is a open-label study. This next phase will further evaluate safety, tolerability and efficacy across three related populations affected by preeclampsia and/or fetal growth restriction. Each of the three sub-cohorts in Part 2 will enroll 30 participants:

Sub cohort 1: women with preeclampsia who are acutely hypertensive and required delivery within 72 hours.

Sub cohort 2: women with preterm preeclampsia and are suitable for expectant management.

Sub cohort 3: women with preterm fetal growth restriction and are suitable for expectant management.

A comprehensive set of outcome data will be collected. While the primary focus is on safety, additional measures will include changes in blood pressure and other indicators that may provide early signals of efficacy. Each sub-cohort will have tailored inclusion and exclusion criteria, as well as slightly different outcome measures to reflect their distinct clinical profiles. Throughout Part 2 of the study, participants will be closely monitored by a member of the research team, with treatment continuing until delivery. Post-delivery, participants will be followed for up to six weeks to ensure close monitoring of their recovery and to gather important postnatal safety data.

VIEW TRIAL DETAILS

DM199 for Pregnancy Complications Trial Collaborators

This study is being conducted at Tygerberg Hospital in Cape Town, South Africa, under the leadership of Professor Catherine Cluver, MD, PhD, Professor of Maternal-Fetal Medicine at Stellenbosch University, in collaboration with DiaMedica. This team is uniquely distinguished as the only group worldwide to have successfully conducted successive clinical trials evaluating novel therapeutics for the treatment of preeclampsia, positioning them as recognized leaders in the field. Part 1 top line study results are anticipated in the second quarter of 2025 and are intended to demonstrate whether DM199 is safe and lowers maternal blood pressure. Additionally, patients with early onset PE will be evaluated for improvements in uterine artery dilation, a sign that DM199 is a potentially disease modifying therapy.

Urgent Need for Breakthroughs

According to the Preeclampsia Foundation, roughly 10 million women around the world suffer from preeclampsia each year1, with no approved treatment options. The only way to stop the disease progression is to deliver the fetus and placenta, often prematurely. In light of this significant unmet medical need, researchers are dedicated to discovering new treatments, with progress dependent on clinical research trials like the DM199 for Pregnancy Complications trial. Given the devastating toll preeclampsia takes on mothers and babies globally, accelerating clinical breakthroughs isn’t just important, it is urgent.

1. Preeclampsia Foundation. “Preeclampsia and Maternal Mortality: A Global Burden”. Preeclampsia And Maternal Mortality: A Global Burden

The safety and effectiveness of DM199 for the treatment of acute ischemic stroke or preeclampsia has not been established and is limited to investigational use only.
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