DiaMedica up on successful FDA meeting for acute ischemic stroke study

 

• DiaMedica Therapeutics (NASDAQ:DMAC) has recently received responses from the FDA following a Type B Pre-IND meeting request, submitted in October 2020 regarding the development plan for its product candidate, DM199, in the treatment of acute ischemic stroke (AIS).
• The Agency agreed with DiaMedica’s proposals regarding plans for an adaptive trial design with a primary endpoint based upon the modified Rankin Scale (mRS) at day 90 and acknowledged that, provided the study results qualify, a single trial may support a Biologics License Application (BLA) submission. Secondary endpoints are anticipated to include stroke recurrence and standard stroke measures.
• The FDA has not recommend any additional studies in preparation for an IND.
• The company plans to submit an investigational new drug (IND) application to the FDA for a Phase 2/3 study in Q1 2021 and expects to enroll ~300 to 350 subjects age 18 and over.
• Ischemic stroke is characterized by the sudden loss of blood circulation to an area of the brain, resulting in a corresponding loss of neurologic function. AIS is caused by thrombotic or embolic occlusion of a cerebral artery.
• https://seekingalpha.com/news/3643277-diamedica-rises-6-on-successful-type-b-meeting-fda-for-dm199-study-in-acute-ischemic-stroke