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
