Benzinga | Dec 10, 2020 08:07AM EST

DiaMedica Therapeutics Announces Successful Type B Meeting With FDA For Study Of DM199 In Patients With Acute Ischemic Stroke; Co. Plans To Submit IND Application For Phase 2/3 Study In Q1 Of 2021

DiaMedica Plans to Submit an Investigational New Drug (IND) Application with to FDA for a Phase 2/3 Study in the First Quarter of 2021

DiaMedica Therapeutics Inc. (NASDAQ:DMAC) announced that it recently received written responses from the FDA following a Type B Pre-IND meeting request that the Company submitted in October 2020 regarding the Company's development plan for its product candidate, DM199, in the treatment of acute ischemic stroke (AIS). DiaMedica believes that the feedback received from the FDA provides a well-defined regulatory pathway and plans to immediately proceed with preparing an IND submission to initiate a Phase 2/3 adaptive trial for the treatment of AIS in the coming months with the objective of commencing participant enrollment in the summer of 2021.

In written responses to the questions provided by DiaMedica, the FDA agreed with DiaMedica's proposals regarding key elements of a Phase 2/3 trial for DM199 in patients with AIS, including plans for an adaptive trial design with a primary endpoint based upon the modified Rankin Scale (mRS) at day 90 and acknowledged that, provided the study results qualify, a single trial may support a Biologics License Application (BLA) submission. Additionally, based upon the clinical and preclinical testing performed to date and currently in process, the FDA did not recommend any additional studies in preparation for an IND submission and initiation of the Company's planned Phase 2/3 trial.

"We appreciate the thoughtful feedback and guidance from the FDA and acceptance of our proposed design for the Phase 2/3 trial of DM199 in patients with acute ischemic stroke," said Rick Pauls, President and CEO of DiaMedica. "Following the guidance the FDA provided in the Type B Pre-IND meeting, we are focused on advancing DM199 as a novel treatment for acute ischemic stroke patients who do not have a treatment option available today, with the added advantage of DM199 having a 24-hour treatment window, extending beyond the current 4.5 hour treatment window of tissue plasminogen activator (tPA). We look forward to initiating the Phase 2/3 study."

DiaMedica is preparing a Phase 2/3 randomized, double-blind, placebo-controlled study. This study is intended to assess the efficacy, safety and tolerability of DM199 in patients with mild to moderate AIS. The study is expected to enroll approximately 300 to 350 male and female subjects age 18 and over. Enrolled participants must have a diagnosis of mild to moderate acute ischemic stroke (NIHSS scores between 5 and 20), and present within 24 hours of symptom onset. Current plans for the study are to exclude patients with large vessel occlusions, which are eligible for treatment with mechanical thrombectomy, and/or patients eligible for tPA. The Company believes that its targeted study population represents approximately 80% of all AIS patients. Study participants will be dosed with either DM199 or placebo over 21 days with the primary endpoint measured at day 90. In order to increase the probability of a successful outcome, the Company also intends to propose conducting an interim analysis with the potential to adjust the study sample size to ensure proper statistical powering, if necessary. The primary endpoint for the Phase 2/3 trial will be the mRS. Secondary endpoints are anticipated to include stroke recurrence and standard stroke measures, including National Institutes of Health Stroke Scale (NIHSS) and Barthel Index.