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.

ABSTRACT:

Introduction

Pre-eclampsia and fetal growth restriction are leading causes of perinatal morbidity and mortality. A therapy that enhances maternal vascular function and promotes vasodilation to increase placental perfusion could treat both conditions.Tissue kallikrein-1 is an endogenous enzyme that releases bradykinin to activate the bradykinin 2 receptor on endothelial cells. This induces potent vasodilation and pro-angiogenic, anti-oxidant and anti-inflammatory effects.DM199 is a recombinant form of tissue kallikrein which can be administered intravenously or subcutaneously. Clinical trials in non-pregnant populations have demonstrated its safety. Being a protein, it is unlikely to cross the placenta. This protocol describes an early-phase trial for DM199 for pre-eclampsia and fet

SUBMITTER: Cluver CA 

PROVIDER: S-EPMC12716557 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature