DiaMedica Inc.
TSX VENTURE : DMA

DiaMedica Inc.

September 30, 2013 08:30 ET

DiaMedica Announces Successful Phase I/II Clinical Results in Type 2 Diabetic Patients

MINNEAPOLIS, MINNESOTA--(Marketwired - Sept. 30, 2013) - DiaMedica (TSX VENTURE:DMA), a clinical stage biopharmaceutical company announced positive results from the second portion of the DM199 Phase I/II clinical trial conducted in Type 2 diabetic patients. The study achieved its primary clinical endpoints of demonstrating the safety, tolerability and sustained pharmacokinetic (PK) properties of DM199, while also suggesting an insulin sensitization mechanism of action for Type 2 diabetes.

The randomized, double-blinded, placebo-controlled study enrolled 10 Type 2 diabetic patients. The patients were dosed with either DM199 at three single ascending dose levels or placebo. DM199 was well-tolerated at all three dose levels by the diabetic patients with no dose limiting side effects. In addition, results from secondary endpoints of the clinical trial assessing glucose control were consistent with an insulin sensitization mechanism of action. Insulin sensitizers lower a patient's blood sugar levels by increasing the body's response to insulin over time. Full results of the study will be published as part of the overall Phase I/II clinical trial.

In a separate study to the ongoing Phase I/II clinical trial, DiaMedica recently completed a Phase I PK study in 14 healthy volunteers demonstrated DM199 has an extended half-life (time required to reduce concentration of drug in body by one-half) confirming earlier PK results. DM199 also had long half-life and similar PK profile in Type 2 diabetic patients.

"The sustained PK profile continues to support once-a-week administration which could play an important role in improving patients compliance and disease management," stated Mr. Rick Pauls, Chairman & CEO of DiaMedica. "DM199 offers a promising new approach to improving glucose control and potentially addresses some of the major complications associated with diabetes."

"We are very encouraged by the results of the single ascending dose study in Type 2 diabetic patients and the PK study. We are now progressing into the chronic 16-day multiple ascending dose (MAD) study in healthy volunteers, followed shortly thereafter with a 28-day study in Type 2 diabetic patients," said Dr. Mark Robbins, Vice President of Clinical and Regulatory Affairs at DiaMedica. "DiaMedica has received regulatory clearance, started subject recruitment, and will initiate the 16-day MAD study on October 1st."

About DiaMedica

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'.

FORWARD-LOOKING STATEMENTS

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.

Contact Information