The Sanford Project & DiaMedica has announced the successful completion of a study involving DM-199 in preventing the onset of Type 1 diabetes in the non-obese diabetic (NOD) mouse model.
With these latest results, DiaMedica's DM-199 program has now demonstrated efficacy in three critical areas of Type 1 diabetes treatment consisting of immune therapy, beta cell therapy, and glucose control.
DM-199 administration to NOD mice, the gold standard animal model for Type 1 diabetes, appeared to prevent the autoimmune attack and thereby the destruction of insulin-producing beta cells in the pancreas which causes Type 1 diabetes.
Under the direction of Dr. Alexei Savinov, Associate Scientist at The Sanford Project, DM-199 showed a significant dose-dependent and dose-frequency dependent delay in the onset of Type 1 diabetes over the 18-week course of treatment (beginning at 6 weeks of age). The Sanford Project and DiaMedica intend to publish the results of this study together in a peer-reviewed publication.
"The results of this study are extremely exciting and suggest that DM-199 has the potential to become a very promising treatment for Type 1 diabetics," said Dr. Alexei Savinov.
"Modulating the auto-immune response and stimulating beta cell regeneration are key strategies in developing novel therapies and cures for type 1 diabetes " stated Dr. Paul Burn, the Broin Chair & Director of The Sanford Project and Professor, Department of Pediatrics at the Sanford School of Medicine, previously Senior Vice President of Research & Development at the Juvenile Diabetes Research Foundation, Global Head of Metabolic Diseases at Hoffman-La Roche, Director of Research at Bayer Pharmaceutical, and former Director of Endocrinology at Eli Lilly.
Burn continued, "DM-199 has now demonstrated its benefits in mouse models of type 1 diabetes. Clinical trials exploring the potential of DM-199 in human settings are the logical next step. We look forward to continue working with DiaMedica towards this goal."
In addition to its immuno-modulating activity in NOD mice, DiaMedica has tested DM-199 in other animal models and demonstrated it also possess beta cell proliferative activity as well as improved glucose control.
Beta Cell Therapy
DM-99, the first generation DiaMedica drug that has been replaced by the advanced DM-199 was shown to increase insulin producing beta cell proliferation by 1,277% resulting in a 300% increase in pancreas insulin levels and a 68% (p=0.05) reduction in fasting blood sugar after three weeks of treatment compared to untreated animals.
In the previously reported study, animals were injected with streptozotocin, a naturally occurring compound known to be toxic to beta cells, in order to mimic Type 1 diabetes with an insult to the beta cells.
Beta cell therapy aims to restore the body's ability to make insulin by proliferating new insulin producing beta cells in the pancreas.
DM-199 improved whole body glucose uptake in a previously reported hyperinsulinemic euglycemic clamp model. Animals treated with a single dose of DM-199 had up to 160% increase in maximal glucose infusion rate.
In a Phase II human proof-of-concept study with the first generation of DM-199, DM-99, diabetics demonstrated an ability to process 31-48% more glucose following a meal compared to patients not on treatment.
Glucose control is the ability to maintain normal blood glucose levels (euglycemia) and prevent high blood sugar (hyperglycemia) thereby reducing the risk of complications from diabetes when blood glucose is not properly controlled.
"We are very pleased with the results from the collaboration with The Sanford Project," stated Rick Pauls, President and Chief Executive Officer of DiaMedica. "These current NOD mouse results are pivotal as they confirm that DM-199 addresses the main concerns of Type 1 diabetes. We look forward to moving ahead with DM-199 and our ongoing collaboration with The Sanford Project."