Announcement • Jun 23

Diamedica Therapeutics Doses First Patients in Phase 2 Trial of DM199 for Treatment of Fetal Growth Restriction

DiaMedica Therapeutics Inc. dosed the first two patients in an investigator-sponsored Phase 2 trial evaluating DM199 (rinvecalinase alfa) for the treatment of fetal growth restriction (FGR). This is the first clinical evaluation of DM199 in FGR. The open-label, single-arm study is designed to evaluate three dose levels of DM199 in up to 30 patients with early-onset FGR. Fetal growth restriction is a serious pregnancy complication in which the fetus fails to reach its expected growth potential, most commonly due to inadequate placental function and reduced maternal uterine blood flow. Globally, FGR affects approximately 10% of pregnancies and is a leading cause of stillbirth, preterm delivery, neonatal complications and long-term health consequences. Severe early-onset FGR, affecting approximately 1 in 500 pregnancies, carries a 15-20% risk of neonatal mortality as well as long-term neurodevelopmental complications. There are currently no approved pharmacologic therapies for FGR. DM199 is a recombinant form of human tissue kallikrein-1 (KLK1), an enzyme that activates natural vasodilatory pathways, including bradykinin-mediated production of nitric oxide, prostacyclin and endothelium-derived hyperpolarizing factor. These molecules relax and dilate blood vessels, increasing blood flow. In FGR, impaired maternal uterine blood flow limits delivery of oxygen and nutrients to the placenta and fetus. By dilating maternal vessels that supply the placenta, DM199 has the potential to improve placental perfusion, support fetal growth and prolong pregnancy. Additionally, as a large recombinant protein therapeutic, DM199 has been shown not to cross the placental barrier into fetal circulation, a potentially important safety advantage in treating pregnancy-related disorders. The open-label Phase 2 investigator-sponsored trial is expected to enroll 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 efficacy endpoints include uterine artery vascular resistance, umbilical artery Doppler findings, fetal growth trajectory, birthweight centile, pregnancy prolongation and DM199 levels in umbilical cord blood at birth. Fetal growth restriction occurs when a fetus fails to reach its genetic growth potential in the womb, most commonly because of placental insufficiency. FGR affects approximately 10% of pregnancies globally and is associated with increased risk of stillbirth, preterm birth, neonatal morbidity and long-term neurodevelopmental, cardiovascular and metabolic complications. Severe early-onset FGR often requires delivery before 32 weeks of gestation. Current management is limited to monitoring and determining the optimal timing of delivery. DM199 (rinvecalinase alfa) is a recombinant form of human tissue kallikrein-1 (rhKLK1) in clinical development for preeclampsia, fetal growth restriction, and acute ischemic stroke. KLK1 is a serine protease enzyme that plays an important role in the regulation of diverse physiological processes via a molecular mechanism that increases production of nitric oxide, prostacyclin and endothelium-derived hyperpolarizing factor.

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