FDA locations maintain on part 2/3 scientific trial of stroke remedy

July 12, 2022

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Disclosures: Gruis and Pauls are employed by DiaMedica Therapeutics Inc.

Biopharmaceutical firm DiaMedica Therapeutics Inc. introduced that the FDA positioned a scientific maintain on its part 2/3 ReMEDy2 trial of an artificial protein remedy for remedy of acute ischemic stroke.

In accordance with a press launch, the maintain was initiated following DiaMedica’s pausing of affected person enrollment and submission of three severe opposed occasion studies to the FDA associated to clinically vital, transient hypotension that occurred shortly after initiation of an IV dose of the therapeutic DM199. Blood stress ranges of the three sufferers recovered again to their baseline blood stress inside minutes after IV infusion was stopped, per the discharge.

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“Affected person security is essential as we plan and conduct our scientific research,” Kirsten Gruis, MD, chief medical officer of DiaMedica, acknowledged within the launch. “Affected person blood stress is well and routinely monitored in stroke sufferers, which is why our examine websites have been capable of shortly establish the problem and instantly cease the dosing of DM199, after which the sufferers then recovered inside minutes and suffered no accidents.”

DiaMedica acknowledged it believes the opposed occasions resulted from switching to an IV bag formulated from totally different supplies within the ReMEDy2 trial in contrast with the IV bag used within the prior part 2 ReMEDy1 trial.

Because of the maintain, DiaMedica could not enroll any extra patients within the ReMEDy2 trial till it supplies the FDA with evaluation of the occasions resulting in or inflicting the hypotension, supplies urged protocol modifications to handle the mitigation of those occasions, provides a rationale and supporting knowledge for the protocol modifications, and the FDA notifies DiaMedica that it might resume enrollment.

“Whereas having to pause enrollment within the ReMEDy2 trial was not fascinating, we stay assured concerning the future potential of DM199 and are dedicated to refining the dosing procedures and strategies that may additional improve affected person security,” DiaMedica President and CEO Rick Pauls mentioned within the launch.

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