Monday, March 2, 2026

Safety and potential efficacy of DM199, a tissue kallikrein-1 analogue, for treating pre-eclampsia and fetal growth restriction: study protocol for a South African, hospital-based phase I/II open-label trial.

Authors: Cluver CA, Thake J, Hassim T, van Greunen A, Budhram S, Knipe K, Decloedt E, Brink L, Langenegger E, Bergman L, Imberg H, Bekker A, Walker SP, Tong S.

DOI: 10.1136/bmjopen-2025-104035

Abstract Summary

Researchers are testing DM199, a recombinant enzyme that promotes vasodilation, as a potential treatment for pre-eclampsia and fetal growth restriction. This Phase IB/IIA trial in South Africa will evaluate safety and optimal dosing in pregnant women, first testing blood pressure reduction in severe cases, then assessing broader efficacy. The protein-based therapy is unlikely to cross the placenta and has shown safety in non-pregnant populations.

Why Brain? ๐Ÿง 

DM199, a kallikrein-1 analogue promoting vasodilation, enters phase I/II trial for pre-eclampsia and fetal growth restrictionโ€”potentially offering a novel treatment for leading causes of perinatal mortality.

Study Limitations:

Single-center study
Open-label trial
Small sample size in dose-finding phase

License: cc by.


The image is AI-generated for illustrative purposes only. Courtesy of Midjourney.

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