Diamedica Inc. completed cGMP manufacturing of DM-199 to be utilized in upcoming clinical trials. Additionally, the company has successfully completed GLP toxicology studies in non-human primates and rat models, and has demonstrated DM-199 to be safe and well-tolerated in repeated high dose administrations. The large-scale proprietary cGMP manufacturing process resulted in a high yield batch of DM-199 to be used in upcoming clinical trials.

The GLP preclinical toxicology studies demonstrate DM-199 is safe and well tolerated at doses at least 25 fold higher than the expected human therapeutic dose over 28-days of repeated-dose and cardiovascular safety studies in non-human primates and rats. The daily administration of DM-199 was safe and well tolerated with no serious adverse events or any other tissue toxicity. Furthermore, DM-199 showed no negative cardiovascular treatment-related effects, including heart rate or ECG intervals, which are important safety attributes for any Type 2 diabetes therapy.

Based on toxicology results, doses previously reported for chronic Type 2 diabetes pre-clinical studies could be increased by at least four-hundred (400) fold, suggesting a large therapeutic window.