CA - DiaMedica: Early 2025 Interim Futility Analysis Could Be A Major Inflection Point

2024-07-11 14:48:34 ET

Summary

• An interim futility analysis by the DSMB of DM199 for patients with AIS in the phase 2/3 ReMEDy2 trial is expected by Q1 of 2025.
• The global acute ischemic stroke therapeutics market size is expected to be worth $14 billion by 2032.
• Proof-of-concept data from a phase 2 study, using DM199 for the treatment of women with pregnancy complications, is expected 1st half of 2025.
• DM199 for pregnancy complications might be ideal because of the ability to potentially be a disease modifying therapy for patients and that it is not expected to cross the placental barrier.

DiaMedica Therapeutics ( DMAC ) is expected to complete enrollment for an interim futility analysis of its phase 2/3 ReMEDy2 clinical trial, using DM199 for the treatment of patients with acute ischemic stroke [AIS]. Enrollment of 144 patients for such an analysis is expected by Q1 of 2025, barring that there are no delays in recruitment. Having said that, this sets up a chance for it to target a very large multibillion-dollar market, where there are no FDA approved therapies. The company is in the process of activating additional trial sites to get this trial enrolled as quickly as possible. Such a move should allow it to reach its target enrollment of 144 patients for the futility analysis by the expected time frame....

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