FDA Institutes Clinical Hold On DiaMedica's Late-Stage Stroke Trial - Read Why

FDA Institutes Clinical Hold On DiaMedica's Late-Stage Stroke Trial - Read Why
  • The FDA placed a clinical hold on DiaMedica Therapeutics Inc's DMAC Phase 2/3 ReMEDy2 trial evaluating 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 related to clinically significant transient hypotension (low blood pressure) occurring shortly after initiating the intravenous (IV) dose of DM199. 
  • The blood pressure levels of the three patients recovered to their baseline within minutes after the 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.
  • The company notes no such hypotension issues were reported in its ReMEDy1 trial, in which 46 stroke patients received DM199.
  • DiaMedica believes that proportionate reductions in the DM199 dose level and IV infusion times will effectively mitigate the hypotension issue. 
  • After completing its compatibility analysis, the company plans to submit a revised ReMEDy2 trial protocol and data to the FDA.
  • Price Action: DMAC shares closed 36.1% lower at $1.29 during after-hours trading on Wednesday.

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