End of Line for INGAP?
There was lots of excitement and hope over Phase 2 trial of INGAP. At one time the positive results were coming in even though one of the participants, I personally know, complained of not benefitting from the trial. We thought he could be part of control group. The final result of Phase 2 trial is now on GMP website and it ain’t looking good.
Today I chanced upon GMP website and the report is grim:
The Phase 2 clinical trials for INGAP Peptide have been completed. The purpose of these studies was to assess whether or not INGAP Peptide demonstrated potential for efficacy as well as safety when administered subcutaneously in daily single doses of 300mg or 600mg for 90 days in type 1 and insulin-requiring type 2 diabetic patients. The studies were conducted at approximately 20 study sites throughout the U.S.; one protocol enrolled 63 patients with type 1 diabetes and the other protocol enrolled 126 patients with type 2 diabetes.
Overall, the efficacy results did not consistently demonstrate a clinically meaningful therapeutic benefit. The results indicate additional research and development activities will be required to enhance and validate the effectiveness of this approach to treating diabetes mellitus. At this time, we are in discussions about potential future development efforts.
Is this the end of line for INGAP?
Filed under Diabetes
