MINNEAPOLIS, MN, USA I September 30, 2013 I 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.
SOURCE: DiaMedica
Post Views: 113
MINNEAPOLIS, MN, USA I September 30, 2013 I 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.
SOURCE: DiaMedica
Post Views: 113
