- The FDA has signed off DiaMedica Therapeutics Inc's DMAC Investigational New Drug (IND) application to proceed with a pivotal Phase 2/3 study of DM199 (recombinant human tissue kallikrein-1or KLK1) for the treatment of patients with Acute Ischemic Stroke (AIS).
- The upcoming pivotal ReMEDy2 trial will evaluate whether DM199 can improve three-month outcomes in AIS patients without other treatment options. It will enroll approximately 350 participants.
- Endpoints will include the modified Rankin Scale, stroke recurrence, the National Institute of Health Stroke Score, Barthel Index, deaths, safety, and tolerability.
- DiaMedica will remain blinded to the data in the interim.
- Price Action: DMAC shares are up 6.9% at $6.95 on the last check Monday.
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