DiaMedica Reports the US FDA’s Clinical Hold on the P-II/III (ReMEDy2) Trial of DM199 for the Treatment of Acute Ischemic Stroke
Shots:
- The clinical hold was implemented by the US FDA due to transient hypotension-related AEs reported in 3 patients that occurred after an IV dose of DM199
- DiaMedica has reported that the AEs occurred due to the unavailability of materials used for the formulation of the IV bag for the P-II (ReMEDy1) trial due to which IV bags for the P-II/III (ReMEDy2) trial were differently formulated. None of the 46 stroke patients receiving DM199 reported hypotension in the P-II (ReMEDy1) trial
- The P-II/III (ReMEDy2) trial evaluates DM199 vs PBO in patients (n=350) with AIS at 75 sites across the US for 3wks. DM199 is a synthetic form of KLK1 human tissue that regulates blood pressure, blood flow, etc.
Ref: Bussinesswire | Image: DiaMedica
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