DiaMedica initiates rat PK study to address FDA nonclinical request for DM199 preeclampsia program

DiaMedica Therapeutics

DiaMedica Therapeutics

DMAC

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  • DiaMedica received FDA written feedback seeking more nonclinical reproductive-toxicity support for DM199 in preeclampsia ahead of a planned U.S. IND.
  • No new study results were presented; the company plans to submit additional rat exposure and activity evidence to FDA once a new PK study finishes.
  • FDA feedback suggests a previously completed rat reproductive-toxicity study could support the IND if DM199 exposure and pharmacologic effect are demonstrated.
  • The added work is intended to keep the U.S. development path moving while preeclampsia studies are initiated in Canada and the UK later this year.


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