DiaMedica Therapeutics (TSX-V:DMA; OTCQB:DMCAF) is a clinical-stage biopharmaceutical company that is developing innovative treatments where there is significant unmet clinical need or where no current therapies are available with a focus on neurological and kidney diseases.
The Company is developing DM199, a recombinant (synthetic) human protein, for patients suffering from neurological and kidney diseases. DM199 has undergone clinical testing that demonstrates its exceptional safety as a potential treatment for a variety of disorders. The Company is positing DM199 for the treatment of diabetic nephropathy and post-insult treatment from acute ischemic stroke (AIS). There are no approved FDA therapeutic treatments for diabetic nephropathy and the only FDA approved treatment for AIS is limited to only 3-4 hours after a stroke.
Five clinical trials in over 100 patients have been conducted with DM199. These studies were designed primarily to establish the safety and tolerability of DM199 and characterize the pharmacokinetics after subcutaneous and intravenous dosing. Importantly, the studies also included regular monitoring of blood pressure. Measurable decreases in blood pressure and/or postural hypotension as the dose-limiting tolerability were observed at doses that generated plasma concentrations of DM199 and consistent with the mechanism of action. We are currently conducting a clinical trial designed to identify a dose of DM199 that is comparable to the human urinary and porcine approved versions in Asia. The results of this study will guide dosing for Phase II and III clinical trials.