DiaMedica Therapeutics reports interim results from DM199 study

DiaMedica Therapeutics (DMAC) Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company, today announced interim results from Part 1a of the Phase 2 study of DM199 for the treatment of preeclampsia. The study achieved pre-specified safety and efficacy endpoints for the Part 1a dose escalation phase, reinforcing the therapeutic potential of DM199. DM199, rinvecalinase alfa, is a recombinant form of the KLK1 protein expected to influence blood pressure regulation and vascular health in the treatment of preeclampsia (PE). Currently, there are no approved pharmacological treatments for the management of PE in the United States and Europe, representing a significant global unmet medical need. The study revealed a dose-dependent reduction in both systolic blood pressure and diastolic blood pressure. Cohort 9 achieved the most substantial mean reductions at five minutes post-infusion. Pooled cohorts 6-9, the potentially therapeutic dose range, exhibited statistically significant mean blood pressure reductions at five minutes, 30 minutes, and 24 hours post-infusion, showing a durable response over time. DM199 demonstrated no placental transfer and no serious treatment emergent adverse events were reported across all cohorts. TEAEs events were mild and limited to nausea, headache and flushing. Additionally, there were no discontinuations of treatment and no inductions of early labor. DM199 also produced a statistically significant reduction in pulsatility index measures, with a 13.2% mean reduction in blood flow resistance at the two-hour mark, indicating a reduction in uterine artery resistance which suggests an improvement in uterine artery blood flow and placental perfusion. Improved perfusion may reduce placental hypoxia, supporting fetal growth and potential disease modification. The uterine artery pulsatility index is a doppler ultrasound measurement that reflects blood flow resistance in the uterine arteries. The company further notes that the DM199 investigator-sponsored Phase 2 trial will proceed with enrollment of the dose expansion cohort. Additionally, based upon the observation of PI reductions in Part 1a, enrollment in the fetal growth restriction cohort will also being initiated.