Preeclampsia, a severe complication of pregnancy characterized by high blood pressure and signs of organ damage, often poses significant risks to both the mother and fetus. Despite its prevalence, effective pharmacological treatments remain limited. The recent Phase 2 trial results for DM199 (rinvecalinase alfa; DiaMedica Therapeutics) represent a promising development in addressing this unmet medical need.
Understanding Preeclampsia
Preeclampsia typically occurs after the 20th week of pregnancy and can lead to premature delivery, maternal organ damage, and fetal growth restrictions. Current management strategies focus on controlling blood pressure and monitoring for complications, often culminating in early delivery to protect both mother and child. The introduction of DM199 offers a novel approach to managing this condition.
Phase 2 Trial Outcomes for DM199
DM199 has shown positive results in Part 1a of its Phase 2 clinical trial, meeting key safety and efficacy endpoints. The trial observed significant dose-dependent reductions in both systolic blood pressure (SBP) and diastolic blood pressure (DBP), with no placental transfer or serious adverse events linked to the drug.
Dr. Cathy Cluver, principal investigator of the trial and leader of the Preeclampsia Research Unit at Tygerberg Hospital in Cape Town, South Africa, stated, “DM199’s ability to safely reduce blood pressure represents an exciting development in the search for an effective treatment for preeclampsia.”
Trial Design and Findings
The trial is an open-label, single-center, proof-of-concept study aiming to enroll up to 90 individuals with preeclampsia and 30 with fetal growth restriction (FGR). Participants averaged 32.5 years of age and were enrolled at a mean gestation of 37 weeks. DM199 was administered via infusion, followed by blood pressure measurements at intervals of 5 minutes, 30 minutes, and 24 hours post-infusion.
The trial reported significant reductions in SBP and DBP, particularly among patients receiving the highest DM199 dose (-35 mmHg and -15 mmHg, respectively). Mean reductions in pooled cohorts were sustained over time, indicating durable responses.
Safety Profile
DM199 demonstrated a favorable safety profile, with mild adverse events such as nausea (14%), headache (11%), and flushing (4%). Importantly, no participants discontinued treatment or experienced induced early labor.
Impact on Blood Flow
The trial also revealed improved uterine artery blood flow and placental perfusion, evidenced by a statistically significant reduction in pulsatility index (PI) measures, with a mean blood flow resistance reduction of 13.2% observed two hours after infusion. This improvement could have positive implications for fetal growth and disease modification.
Future Directions
The study’s promising results have prompted plans to enroll a dose expansion cohort and an FGR cohort. DiaMedica Therapeutics CEO Rick Pauls expressed optimism, stating, “The reductions in blood pressure and pulsatility index are consistent with DM199’s mechanism of action, signaling its potential to benefit this underserved patient population.”
Broader Implications for Maternal and Infant Health
Effective management of preeclampsia is crucial not only for maternal health but also for reducing risks of adverse neurodevelopmental outcomes in preterm infants. Research continues to explore the relationship between hypertensive disorders of pregnancy and infant development, highlighting the importance of advancing therapeutic options.
Conclusion
DM199’s Phase 2 trial results mark a significant step forward in addressing preeclampsia, offering hope for improved maternal and infant outcomes. As further studies unfold, DM199 may emerge as a key player in redefining care for this challenging condition.
References
- DiaMedica Therapeutics reports positive interim phase 2 preeclampsia results: statistically significant reductions in blood pressure and no placental transfer. DiaMedica Therapeutics Inc. July 17, 2025. Accessed July 17, 2025. https://www.businesswire.com/news/home/20250717976890/en/DiaMedica-Therapeutics-Reports-Positive-Interim-Phase-2-Preeclampsia-Results-Statistically-Significant-Reductions-in-Blood-Pressure-and-No-Placental-Transfer
- Krewson C. Maternal hypertension linked to neurodevelopment risks in preterm infants. Contemporary OB/GYN. May 6, 2025. Accessed July 17, 2025. https://www.contemporaryobgyn.net/view/maternal-hypertension-linked-to-neurodevelopment-risks-in-preterm-infants
