Clinical stage biopharmaceutical firm DiaMedica has reported encouraging results from the second portion of the DM199 Phase I/II clinical trial conducted in type 2 diabetic patients.
The company said the randomised, double-blinded, placebo-controlled study achieved its primary clinical endpoints of demonstrating the safety, tolerability and sustained pharmacokinetic (PK) properties of DM199, while also suggesting an insulin sensitisation mechanism of action for type 2 diabetes.
Under the study, the company enrolled ten type 2 diabetic patients, who were dosed with either DM199 at three single ascending dose levels or placebo.
The company found that DM199 was well-tolerated at all three dose levels by the diabetic patients with no dose limiting side effects.
Results from secondary endpoints of the clinical trial assessing glucose control were also consistent with an insulin sensitisation mechanism of action.
DiaMedica expects to publish the full results of the study as part of the overall Phase I/II clinical trial.
DiaMedica clinical and regulatory affairs vice-president Mark Robbins said the company is 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.
"DiaMedica has received regulatory clearance, started subject recruitment, and will initiate the 16-day MAD study on 1 October," Robbins added.
In addition, DiaMedica completed a Phase I PK study in 14 healthy volunteers recently, which demonstrated that DM199 has an extended half-life confirming earlier PK results.
The study showed DM199 also had long half-life and similar PK profile in type 2 diabetic patients.
DiaMedica chairman and CEO Rick Pauls said the sustained PK profile continues to support once-a-week administration, which could play an important role in improving patients compliance and disease management.
"DM199 offers a promising new approach to improving glucose control and potentially addresses some of the major complications associated with diabetes," Pauls said.
DM199 is a novel human recombinant protein currently under development for the treatment of type 1 and type 2 diabetes.