DiaMedica Therapeutics, Inc. (DMAC) said early Thursday that the Food and Drug Administration has accepted its investigational new drug application for the initiation of a phase 1b clinical trial of DM199 in patients with moderate or severe chronic kidney disease (CKD) caused by Type I or Type II diabetes.
The multi-site clinical study will enroll 32 subjects to evaluate DM199’s safety, tolerability and drug levels, according to a Form 8-K filing. The study will enroll subjects over a 12-day period and will also include other end-points that include renal biomarkers.
The results will assist DiaMedica in the design of upcoming phase 2 studies in patients suffering from rare diseases and CKD. The DM199 drug levels from the phase 1b study will also help determine the optimal dose levels for testing in phase 2 studies.
“We anticipate completing the phase 1b study by mid-2019 and the phase 2 study in Q4 2019 or Q1 2020,” CEO Rick Pauls said.