What's Happening?
DiaMedica Therapeutics has announced progress in its development of DM199, a treatment for preeclampsia, following a pre-IND meeting with the FDA. The FDA has requested an additional non-clinical study
in a rabbit model to further evaluate the treatment's safety and efficacy. DiaMedica is preparing for this study, with results expected by the second quarter of 2026. The company is also conducting a Phase 2 trial in South Africa, which has shown promising results in reducing blood pressure and improving uterine artery dilation without transferring the drug to the placenta. DM199 is a recombinant form of human tissue kallikrein-1, aimed at addressing serious ischemic diseases.
Why It's Important?
Preeclampsia is a significant cause of maternal and neonatal morbidity and mortality worldwide. DiaMedica's development of DM199 represents a potential breakthrough in treating this condition, which currently lacks effective therapeutic options. The FDA's guidance and the ongoing clinical trials are crucial steps toward bringing this treatment to market. Success in these trials could lead to improved outcomes for pregnant women and their babies, reducing the health risks associated with preeclampsia. The development also highlights the importance of innovative biopharmaceutical research in addressing unmet medical needs.
What's Next?
DiaMedica will continue its preparations for the additional non-clinical study as requested by the FDA. The company plans to submit an Investigational New Drug (IND) application for DM199 in preeclampsia patients. Ongoing engagement with the FDA will be critical as DiaMedica seeks to advance its clinical trials and ultimately secure regulatory approval. The results of the upcoming studies will be pivotal in determining the future of DM199 as a viable treatment option for preeclampsia.
