DiaMedica Therapeutics Inc. provided an update on their DM199 Preeclampsia Program after a successful pre-IND meeting with the FDA.
The FDA requested an additional non-clinical study in a rabbit model, which is expected to provide regulatory clarity for the study of DM199 in early onset preeclampsia.
Results from this study are anticipated to be available by the second quarter of 2026.
Regulatory Clarity
Meeting minutes affirmed FDA's request for an additional non-clinical study in a rabbit model for DM199 in early onset preeclampsia.
Phase 2 Trial Progress
Interim data from the Phase 2 trial in South Africa show positive safety and efficacy signals with no placental transfer of DM199.
Therapeutic Candidate
DM199, a recombinant form of human tissue kallikrein-1, shows promise in treating preeclampsia, fetal growth restriction, and acute ischemic stroke.
- The positive interim data from the Phase 2 trial in South Africa indicate promising safety and efficacy signals for DM199 in late-stage preeclampsia.
- The FDA's request for an additional non-clinical study reflects the importance of thorough regulatory evaluation for DM199 in early onset preeclampsia.
DiaMedica Therapeutics is making significant progress in advancing DM199 as a potential treatment for preeclampsia. The ongoing trials and regulatory interactions highlight the company's commitment to addressing critical maternal and neonatal health conditions.