Akesis expands preclinical safety program for diabetes drug

While an analysis of the one-month preclinical safety studies is ongoing, the company has initiated a three-month preclinical safety program in order to support further clinical evaluation of its product.

Combined with the thorough analysis of the recent Phase IIa study of AKP-020 in diabetic subjects, the company anticipates a delay in the next phase of clinical studies where the next human study would not begin until the second half of 2009, following appropriate regulatory feedback.

Jay Lichter, chairman and CEO of Akesis, said: “While we remain optimistic about AKP-020 as a potential therapy for diabetes, we believe that an expansion of our preclinical programs is necessary to further our understanding of the benefit and risk profile of AKP-020 prior to the initiation of additional clinical studies.

“Contingent on the results of this expanded program, we anticipate being in a position to better define our future development strategy and timeline for AKP-020.”