FDA lifts clinical hold on DiaMedica's DM199 phase 2/3 stroke trial; resumption planned

DiaMedica Therapeutics Inc.

FDA removed clinical hold on ReMEDy2 trial studying DM199 for acute ischemic stroke.
Protocol amendment includes reduced IV dose of DM199 and additional safety measures against severe hypotension.
Primary endpoint changed to modified Rankin Scale (mRS) at day 90; secondary endpoints include mRS shift, death, NIHSS, Barthel Index.
Trial to enroll ~350 patients at ~75 U.S. sites; excludes tPA and mechanical thrombectomy patients.
CEO Rick Pauls and CMO Kirsten Gruis comment on re-engaging study sites.

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