MINNEAPOLIS, MINNESOTA--(Marketwired - Jan. 9, 2014) - DiaMedica (TSX VENTURE:DMA), a clinical stage biopharmaceutical company announced today it has met the primary endpoints of safety and tolerability from the recently completed 16-day Phase 1 multiple ascending dose (MAD) of DM199 in healthy volunteers. DiaMedica has also initiated dosing of the first Type 2 diabetic patients in a one-month DM199 Phase 2 clinical trial. 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.
"We are very pleased to have completed our 16 day Phase 1 study and have the first patients started on treatment in our chronic Phase 2 clinical program of DM199 in Type 2 diabetic patients," stated Rick Pauls, Chairman & CEO for DiaMedica. "DM199 is based on a naturally occurring protein and has the potential to treat Type 2 diabetes, control blood pressure and improve kidney function."
In the recently completed Phase 1 MAD clinical 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 the Phase 1 clinical results, DiaMedica has initiated a Phase 2 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 one-month, 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.
DiaMedica Inc. is a publicly traded (TSX VENTURE:DMA) clinical stage biopharmaceutical company focused on the discovery and development of novel therapies to treat diabetes and the complications associated with diabetes. DiaMedica's lead clinical stage compound, DM199, is a recombinant human protein known as rhKLK1 that represents a novel approach to treating diabetes and associated complications. DiaMedica is also developing a novel monoclonal antibody, DM204 for the treatment of Type 2 diabetes, which is in preclinical development.
The Company is listed on the TSX Venture Exchange in Canada under the trading symbol 'DMA'.
The statements made in this press release that are not historical facts contain forward-looking information that involves risk and uncertainties. All statements, other than statements of historical facts, which address DiaMedica's expectations, should be considered forward-looking statements. Such statements are based on management's exercise of business judgment as well as assumptions made by and information currently available to management. When used in this document, the words "may", "will", "anticipate", "believe", "estimate", "expect", "intend" and words of similar import, are intended to identify any forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements reflect a current view of future events and are subject to certain risks and uncertainties as contained in the Corporation's filings with Canadian securities regulatory authorities. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results could differ materially from those anticipated in these forward-looking statements. The Corporation undertakes no obligation, and does not intend, to update, revise or otherwise publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of any unanticipated events. Although management believes that expectations are based on reasonable assumptions, no assurance can be given that these expectations will materialize.