DiaMedica says FDA puts clinical hold on Phase 2/3 ReMEDy2 trial

DiaMedica Therapeutics announced that the U.S. Food and Drug Administration has placed a clinical hold on the company's Phase 2/3 ReMEDy2 trial studying the use of the company's product candidate, DM199, to treat acute ischemic stroke patients. The clinical hold was initiated following the company's pause in patient enrollment and submission of three serious adverse event reports to the FDA related to clinically significant, transient hypotension occurring shortly after initiation of the intravenous dose of DM199. The blood pressure levels of the three patients recovered back to their baseline blood pressure within minutes after IV infusion was stopped. The company believes that the adverse events resulted from switching to an IV bag formulated from different materials in the ReMEDy2 trial compared to the IV bag used in the prior Phase 2 ReMEDy1 trial. Due to supply issues, the type of IV bag used in the ReMEDy1 trial was not available in many U.S. hospitals, and accordingly after routine compatibility testing, a different type of IV bag was selected for use in the ReMEDy2 trial. As part of the Company's evaluation of the events that lead to these hypotensive events, the Company is confirming the differences in drug absorption in the IV bags used in the ReMEDy1 trial compared to the ReMEDy2 trial and plans to work with the FDA to modify the ReMEDy2 trial protocol to adjust the DM199 IV dosing to more closely match the dosing in the ReMEDy1 trial, taking into account these differences. The company notes that no such hypotension issues were reported in its ReMEDy1 trial in which 46 stroke patients received DM199. The company may not enroll any additional patients in the ReMEDy2 trial until the company provides the FDA with the company's analysis of the events leading to or causing the hypotension, its suggested protocol modifications to address the mitigation of these events, its rationale and supporting data for the protocol modifications, and the FDA notifies the company that it may resume enrollment in the clinical trial. Based on information received to date, DiaMedica believes that proportionate reductions in the DM199 dose level and IV infusion times will effectively mitigate the hypotension issue in ReMEDy2 patients. The company plans to submit a revised ReMEDy2 trial protocol with the supporting rationale and data to the FDA for review upon completion of its compatibility analysis.