Business
DiaMedica Therapeutics Announces Third Quarter 2019 Financial Results and Provides Business Update
Phase II Study of DM199 in Chronic Kidney Disease Commences Screening REMEDY Phase II Study of DM199 in Acute Ischemic Stroke Completes Enrollment Management
About this update from Diamedica Therapeutics Inc.
[{"type":"text","content":"\n\nPhase II Study of DM199 in Chronic Kidney Disease Commences Screening\n\n\nREMEDY Phase II Study of DM199 in Acute Ischemic Stroke Completes Enrollment\n\n\nManagement Team Strengthens with Sydney Gilman, Ph.D., Vice President of Regulatory Affairs\n\n\nConference Call with Management Tomorrow, November 14 at 7am CT\n\n\n MINNEAPOLIS--(BUSINESS WIRE)--\nDiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for kidney diseases and neurological disorders, today provided a business update and reported its financial results for the three and nine months ended September 30, 2019.\n\n\nClinical Developments\n\n\nDM199 for the Treatment of Chronic Kidney Disease \n\n\nPhase Ib Clinical Study in Patients with CKD Completed\n\n\nDiaMedica has completed its Phase Ib clinical trial of DM199, a recombinant form of the endogenous human tissue kallikrein protein (KLK1), in patients with moderate or severe Chronic Kidney Disease (CKD) caused by Type I or Type II diabetes mellitus. The study was performed to assess the pharmacokinetics (PK) of three dose levels of DM199 (3, 5 and 8 µg/kg), administered in a single subcutaneous dose, as well as the evaluation of safety, tolerability and secondary pharmacodynamic (PD) endpoints.\n\n\nThe Company previously announced positive interim results. PK profiles, at the 3µg/kg dose level, were similar between moderate and severe CKD patients, and consistent with healthy subjects (normal kidney function) tested previously. Therefore, the Company does not believe dosing adjustment is warranted, based on the presence or severity of CKD and a full renal study will likely not be required. Final study results indicated that DM199 was observed to be well tolerated with no dose-limiting tolerability. There were no deaths, no discontinuations due to a treatment-related adverse event (AE), and no treatment-related significant adverse events (SAEs). AEs were minor and consistent with standard treatment(s) in the CKD patient population.\n\n\nFavorable overall PD results were also observed including short-term improvements in Nitric Oxide (NO), average increase of 35.2%, Prostaglandin E2 (PGE2), average increase of 41.2%, estimated glomerular flow rate (eGFR), average increase of 4.08 mL/min/1732, and the urinary albumin to creatinine ratio (U...