Akesis will initiate the trial after FDA approval. The trial will be performed by dgd Research of San Antonio and will be designed to measure efficacy (using the gold-standard euglycemic-hyperinsulinemic clamping test), pharmacokinetic parameters, safety and tolerability of AKP-020 in diabetics. The company is currently projecting the trial to begin in the fourth quarter of 2007.
Jay Lichter, president and CEO of Akesis, said: “The IND filing is an important milestone for the company, and we continue to stay on track with our development timeline.”