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DiaMedica Completes MAD Trial

Will begin Ph II diabetes trial of DM199

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

DiaMedica has met the primary endpoints of safety and tolerability from its recently completed 16-day Phase I multiple ascending dose (MAD) of DM199 in healthy volunteers. DM199 is a recombinant human tissue kallikrein-1 (rhKLK-1) protein and a novel treatment for diabetes and its complications by targeting the Kallikrein-Kinin System.

In the Phase I trial of 18 healthy volunteers, DM199 was well-tolerated at all three dose levels and met the primary endpoints of safety and tolerability. DM199 also demonstrated a favorable pharmacokinetic profile supporting the potential for weekly dosing.

Based on those results, DiaMedica has initiated a Phase II clinical study in patients with Type 2 diabetes to evaluate the safety, tolerability and pharmacokinetics of two dose levels of DM199 and its effects on diabetes biomarkers, including: HOMA2-IR, fasting glucose and plasma insulin, meal tolerance test, lipids, HbA1c and other metabolic markers. The randomized, double-blinded, placebo-controlled study is expected to enroll 36 patients with Type 2 diabetes. The patients will start with a one-month wash-out of their diabetes mediations and then be sequestered for the one-month study.

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