The US Food and Drug Administration (FDA) has accepted the addition of stroke recurrence as a second independent primary endpoint to DiaMedica Therapeutics’ ReMEDy2 Phase II/III trial assessing DM199 to treat acute ischemic stroke (AIS).
DM199 is a recombinant (synthetic) human tissue kallikrein-1 (KLK1) protein that regulates many physiological processes such as oxidative stress, fibrosis, blood flow, inflammation and neurogenesis through a molecular process.
This double-blind, randomised, adaptive design placebo-controlled Phase II/III study is aimed at assessing DM199’s efficacy and safety to treat AIS.
The regulatory acceptance will allow DiaMedica to assess its DM199’s impact on physical recoveries after the acute ischemic stroke and the AIS recurrent rate as two separate primary goals.
The Phase II/III trial is studying acute ischemic stroke in patients for whom thrombolysis and/or a catheter-based procedure, mechanical thrombectomy, are not medically possible because of clot location, comorbidity risks or even time from the estimated stroke onset.
In the ReMEDy2 trial, the recovery from stroke in patients will be measured by the modified Rankin Scale (mRS) at day 90 and the rate of ischemic stroke recurrence will be assessed based on the proportion of patients experiencing recurrent AIS at day 90.
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DiaMedica CEO Rick Pauls said: “The medical need to develop new and better treatments for AIS is clear. Based upon our encouraging clinical experience in our Phase 2 study, we are very pleased to be formally elevating AIS recurrence to a primary endpoint in our ReMEDy2 study.
“This provides another pathway to potential success in this trial, but more importantly, underscores the importance of evaluating DM199’s potential to reduce AIS patients’ risk of suffering a recurrent stroke, which is often more disabling and fatal.”
DiaMedica stated that the addition of ischemic stroke recurrence to the trial as a second independent primary endpoint is based on the data from the company’s ReMEDy Phase 2 study, conducted in 91 subjects.
According to this data, six patients in the placebo arm experienced strokes while there were no such cases in the DM199 arm during the 90-day follow-up period.
Excluding the patients who were earlier treated with mechanical thrombectomy, four patients experienced a recurrent ischemic stroke of the placebo arm, and all those cases were fatal while the DM199 arm faced no such event.