Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)

 Ask your competent? doctor to explain the previous FDA hold on this research and notify you of the results when research is completed. No knowledge of this at all is fucking complete incompetence! I expect my doctors and therapists to be completely up to date on all research in the stroke field. You should be getting this information from your doctor, not me.

DM199 (2 posts to August 2022)

Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)

ClinicalTrials.gov ID NCT05065216

Information Provided by Scott Kasner, MD Study Start (Actual) 2021-11-07 Primary Completion (Estimated) 2026-12 Study Completion (Estimated) 2026-12 Enrollment (Estimated) 728 Study Type Interventional Last Update Posted 2025-09-25 Study Overview Brief Summary This is a Phase 2/3 study evaluating the safety and efficacy of ClinicalTrials.gov ID NCT05065216 Sponsor DiaMedica Therapeutics Inc Information Provided byScott Kasner, MD< Study Start (Actual)2021-11-07 Primary Completion (Estimated) 2026-12 Study Completion (Estimated) 2026-12 Enrollment (Estimated) 728 Study Type Interventional Last Update Posted 2025-09-25 Study Overview>This is a Phase 2/3 study evaluating the safety and efficacy of DM199 (rinvecalinase alfa) in treating participants with moderate stroke severity, who present within 24 hours of Acute Ischemic Stroke (AIS) onset due to small and medium vessel occlusions. This study focuses on participants with limited treatment options. Participants who have or will receive mechanical thrombectomy (MT) are not eligible for participation. Additionally, participants who have received fibrinolytics are excluded unless they experience a persistent neurological deficit of moderate severity six or more hours after fibrinolytic treatment. Participants considered for this trial should not be denied the use of standard of care (SoC) AIS therapies, such as fibrinolytics or MT, when appropriate. The double-blinded study will be randomized and placebo-controlled at up to approximately 100 sites.To learn more, visit ClinicalTrials.gov (rinvecalinase alfa) in treating participants with moderate stroke severity, who present within 24 hours of Acute Ischemic Stroke (AIS) onset due to small and medium vessel occlusions. This study focuses on participants with limited treatment options. Participants who have or will receive mechanical thrombectomy (MT) are not eligible for participation. Additionally, participants who have received fibrinolytics are excluded unless they experience a persistent neurological deficit of moderate severity six or more hours after fibrinolytic treatment. Participants considered for this trial should not be denied the use of standard of care (SoC) AIS therapies, such as fibrinolytics or MT, when appropriate. The double-blinded study will be randomized and placebo-controlled at up to approximately 100 sites.ClinicalTrials.gov

FDA removes hold on investigational new drug application for ischemic stroke therapy

Do your doctors and hospital even know about this?

Do you prefer your doctor and hospital incompetence NOT KNOWING? OR NOT DOING?

 

 

FDA removes hold on investigational new drug application for ischemic stroke therapy

The FDA has removed the clinical hold on the investigational new drug application for the phase 2/3 ReMEDy2 trial of DM199 for acute ischemic stroke, DiaMedica Therapeutics announced in a press release.

“We are pleased that the FDA has fully lifted the clinical hold,” DiaMedica President and CEO Rick Pauls, MBA, said in the release. “DM199 represents a novel approach to treating [acute ischemic stroke] patients, principally aimed at enhancing collateral blood flow in the brain tissues affected by the stroke.”

The FDA removed a hold on DiaMedica’s IND application for a phase 2/3 clinical trial of a novel therapy for acute ischemic stroke. Image: Adobe Stock

According to the release, DM199 is a synthetic form of human tissue kallikrein-1, a serine protease involved in several physiological processes, including blood flow, inflammation, fibrosis, oxidative stress and neurogenesis. Deficiency of the protein may play a role in vascular disease such as stroke and vascular dementia.

The company plans to resume its ReMEDy2 trial as soon as possible and aims to enroll approximately 350 individuals at 75 sites in the U.S. Participants will receive DM199 or placebo for 3 weeks, beginning within 24 hours of acute ischemic stroke symptoms, with the final follow-up scheduled for 90 days.

“We look forward to re-engaging with our study sites and stroke expert principal investigators as we resume our ReMEDy2 trial, as there is continued unmet need of new potential therapeutics for patients who have had an ischemic stroke,” Kirsten Gruis, MD, DiaMedica’s chief medical officer, said in the release.

FDA places hold on phase 2/3 clinical trial of stroke therapy

What is your doctor's competence level on knowing about this research? NONE?

FDA places hold on phase 2/3 clinical trial of stroke therapy

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.

Source: Adobe Stock.

“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.