Development will resume pending discussion of plans and protocols with the FDA, with a mid phase clinical trial expected to begin in the fourth quarter of 2005.
The problems occurred during part of the study when CS-917 was used in combination with diabetes drug metformin, and the companies now acknowledge that “additional clinical evaluation will be required to determine if CS-917 can be safely combined with metformin.”
Dr Tomas Bocanegra, vice president of clinical development at Sankyo’s US subsidiary stated, “Of course, our number one priority is patient safety which is why we choose to hold full development of CS-917 after the serious adverse events occurred in the metformin interaction study. However, after a careful review of the results of that study as well as the program as a whole and after discussions with medical and regulatory experts we have concluded that development of CS-917 should resume.”
CS-917, discovered by Metabasis, selectively inhibits the gluconeogenesis pathway responsible for the abnormal overproduction of glucose in the liver of type 2 diabetes patients. Thus, by specifically inhibiting this pathway, liver glucose production should be reduced and blood sugar levels decreased.
If successfully developed, CS-917 is expected to be used alone or in combination with other diabetes therapies such as insulin sensitizers and sulfonylureas.