DiaMedica Therapeutics Provides a Business Update and Announces Third Quarter 2023 Financial Results
DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal disease, today provided a business update and financial results for the quarter ended September 30, 2023. Management will host a conference call Tuesday, November 14, 2023, at 8:00 AM Eastern Time / 7:00 AM Central Time to discuss its business update and third quarter 2023 financial results.
Following in-depth discussions of the ReMEDy2 Phase 2/3 protocol design with global stroke experts, the scientific advisory board and current investigators, the Company has made several important amendments to the protocol. These changes were submitted to the U.S. Food and Drug Administration (FDA) in early October and the Company is proceeding with use of the amended protocol as the FDA did not issue any comments during the 30-day review period which ended on November 3, 2023.
These study modifications include focusing participant eligibility to those subjects with only moderate acute ischemic strokes in the anterior circulation. Moderate strokes are commonly defined as those stroke patients having a baseline National Institute of Health Score (NIHSS) of 5-15. Moderate severity strokes frequently result from occlusions in small vessels, and if diagnosed after the tPA treatment window has closed, typically have limited treatment alternatives as they are generally not candidates for mechanical thrombectomy. The exclusion of posterior circulation (PC) strokes aligns with enrollment criteria used by Techpool Bio-Pharma, the marketer of urinary-derived KLK1, called KAILIKANG®, in their registration studies in China. Given the ReMEDy2 primary endpoint of modified Rankin score (mRS) of 0-1 (excellent outcome), the Company believes that focusing on strokes of moderate severity will maximize the potential performance improvement in participants treated with DM199 vs. placebo, meaning that this change should increase the number of participants receiving DM199 achieving an excellent outcome as compared to the placebo group. This change is also consistent with results from the Company’s Phase 2, ReMEDy1 stroke trial, where the subgroup of participants with moderate strokes, not receiving mechanical thrombectomy prior to enrollment, showed a greater percentage of patients on DM199 achieving an mRS of 0-1 compared to placebo, recognizing that the trial had a relatively small number of participants.
“The revisions we are implementing to the ReMEDy2 trial protocol reflect the feedback we’ve received from clinical sites and stroke key opinion leaders and follows more closely the clinical studies with KAILIKANG® in China,” said Jordon Dubow, M.D., DiaMedica’s Interim Chief Medical Officer. “With these changes, we aim to leverage new insights and data to optimize our trial execution, accelerate the involvement of new clinical sites, and ultimately, enhance the robustness of our study findings.
