FDA places hold on phase 2/3 clinical trial of stroke therapy
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Biopharmaceutical company DiaMedica Therapeutics Inc. announced that the FDA placed a clinical hold on its phase 2/3 ReMEDy2 trial of a synthetic protein therapy for treatment of acute ischemic stroke.
According to a press release, the hold was initiated following DiaMedica’s pausing of patient enrollment and submission of three serious adverse event reports to the FDA related to clinically significant, transient hypotension that occurred shortly after initiation of an IV dose of the therapeutic DM199. Blood pressure levels of the three patients recovered back to their baseline blood pressure within minutes after IV infusion was stopped, per the release.
“Patient safety is very important as we plan and conduct our clinical studies,” Kirsten Gruis, MD, chief medical officer of DiaMedica, stated in the release. “Patient blood pressure is easily and routinely monitored in stroke patients, which is why our study sites were able to quickly identify the issue and immediately stop the dosing of DM199, after which the patients then recovered within minutes and suffered no injuries.”
DiaMedica stated it believes the adverse events resulted from switching to an IV bag formulated from different materials in the ReMEDy2 trial compared with the IV bag used in the prior phase 2 ReMEDy1 trial.
As a result of the hold, DiaMedica may not enroll any additional patients in the ReMEDy2 trial until it provides the FDA with analysis of the events leading to or causing the hypotension, provides suggested protocol modifications to address the mitigation of these events, supplies a rationale and supporting data for the protocol modifications, and the FDA notifies DiaMedica that it may resume enrollment.
“While having to pause enrollment in the ReMEDy2 trial was not desirable, we remain confident about the future potential of DM199 and are committed to refining the dosing procedures and methods that will further enhance patient safety,” DiaMedica President and CEO Rick Pauls said in the release.