DiaMedica Therapeutics Inc

Preeclampsia Program

In June 2024, the Company announced the expansion of the Company’s DM199 clinical development program into preeclampsia (PE). PE is a serious pregnancy disorder that typically develops after the 20th week of gestation, characterized by high blood pressure and damage to organ systems, often the kidneys and liver. Affecting up to 8% of pregnancies worldwide, preeclampsia can pose significant risks to both the mother and baby, including risk of stroke, placental abruption, progression to eclampsia, premature delivery, and death. Symptoms may include severe headaches, vision changes, upper abdominal pain and swelling in the hands and face. Delivery of the baby, often very prematurely, is the only available option for stopping the progression of preeclampsia. Additionally, once women have had preeclampsia, they have three to four times the risk of developing high blood pressure and double the risk for heart disease and stroke. Currently, there are no approved therapeutics for PE in the United States or Europe.

DM199 has the potential to lower blood pressure, enhance endothelial health, and improve perfusion to maternal organs and the placenta. The Company has also completed studies on fertility, embryofetal development and pre- and post-natal development in animal models, which support the potential safety in pregnant humans. Additionally, the Company recently completed a placental transfer study in pregnant rats in which DM199 did not cross the placental barrier. Specifically, DM199 was detectable in the maternal blood, but undetectable in the fetal blood.

A Phase 2 PE trial is scheduled to be initiated in the fourth quarter of 2024. The trial is expected to be an open-label, single center, single-arm, safety and pharmacodynamic, proof-of-concept, investigator-sponsored study of DM199 for the treatment of PE at the Tygerberg Hospital, Cape Town, South Africa. Up to 90 women with PE, and potentially an additional 30 subjects with fetal growth restriction, may be evaluated with the first subject anticipated to be enrolled in the fourth quarter of 2024. Part 1A topline study results are intended to demonstrate initial proof-of-concept results including whether DM199 is safe, lowers blood pressure, dilates intrauterine arteries to increase placental blood flow and several biomarkers and are expected in the first half of 2025.

On July 29, 2024, the Company hosted a Preeclampsia Key Opinion Leader (KOL) Event. A replay of the event is available atclick here.

In conjunction with the webinar, DiaMedica released a white paper titled “The Potential of DM199 to Treat Preeclampsia”. The white paper can be downloaded from the Literature & Publications section of DiaMedica.com or,click here.