The completion of cGMP manufacturing, which resulted in a high yield batch of DM-199, allows the company to use DM-199 compound in its upcoming clinical trials.
The company has also completed pre-clinical GLP toxicology studies in non-human primates and rat models, which demonstrated that DM-199 is safe and well-tolerated at doses at least 25 fold higher than the expected human therapeutic dose over 28-days.
DiaMedica chairman and CEO Rick Pauls said with the completion of cGMP manufacture of DM-199, the company is working on its regulatory package for a Phase I/II clinical trial which includes Type 2 diabetic patients.
"The trial design will also allow us to enter Phase 2 trials for multiple indications," Pauls added.
"Achieving a proprietary, commercially viable manufacturing process of DM-199 and a comprehensive patent position including composition of matter, methods of uses and route of delivery should create a significant barrier to entry for any follow-on competitors."