The first patients have been dosed in a Phase 2 study of DM199 for fetal growth restriction, a pregnancy complication with no approved pharmacological treatments.

DiaMedica Therapeutics has announced that the first patients have been dosed in a Phase 2 clinical trial evaluating DM199 (rinvecalinase alfa) for the treatment of fetal growth restriction (FGR).

The investigator-sponsored study marks the first clinical evaluation of DM199 in FGR, a serious pregnancy complication that occurs when a fetus fails to reach its expected growth potential in the womb, most commonly because of placental insufficiency and reduced maternal blood flow to the placenta.

FGR affects an estimated 10% of pregnancies worldwide and is associated with increased risks of stillbirth, preterm birth, neonatal complications and long-term developmental problems. Severe early-onset FGR affects around one in 500 pregnancies and can carry a neonatal mortality risk of up to 20%.

Despite the significant burden of disease, there are currently no approved pharmacological treatments for FGR, with clinical management largely limited to monitoring fetal development and determining the safest timing for delivery.

The open-label Phase 2 study will evaluate three dose levels of DM199 in up to 30 women with early-onset FGR between 27 and 32 weeks of gestation.

The primary objective is to assess safety and tolerability. Exploratory endpoints include measures of uterine artery blood flow, fetal growth, birthweight, pregnancy prolongation and levels of the treatment detected in umbilical cord blood at birth.

DM199 is a recombinant form of human tissue kallikrein-1, an enzyme involved in regulating blood vessel function. The therapy is designed to improve maternal uterine blood flow to the placenta, increasing the delivery of oxygen and nutrients to the developing fetus.

According to DiaMedica, DM199 does not cross the placental barrier into fetal circulation, a characteristic that could be important in the development of therapies for pregnancy-related disorders.

Professor Catherine Cluver, lead investigator of the study and professor of maternal-fetal medicine at Stellenbosch University, said: “Fetal growth restriction is one of the most heartbreaking conditions we manage, because today we can only monitor the baby and decide when to deliver, often far too early. The pathology underlying fetal growth restriction is directly linked to impaired placental perfusion and abnormal maternal uterine vascular function.

“A therapy that could restore blood flow to the placenta would represent a fundamental shift in how we approach this condition.”

The study is expected to provide initial safety data and early insights into whether improving placental blood flow could offer a new therapeutic approach for a condition that currently has limited treatment options beyond early delivery.