SAN DIEGO--(BUSINESS WIRE)--Akesis Pharmaceuticals, Inc. (OTCBB:AKES), an emerging diabetes drug-development company, today announced the filing of a preliminary Investigational New Drug (pre-IND) application with the U.S. Food and Drug Administration (FDA) for its lead product candidate AKP-020. The purpose of the pre-IND is to obtain a meeting with FDA officials, which typically occurs 60 days after submitting the application, to review data supporting an IND application and to discuss proposed trial protocol. Once Akesis has an IND approved by the FDA, the Company intends to initiate a Phase Ib/IIa trial to assess the safety and efficacy, and determine the pharmacokinetics of AKP-020 in patients with Type 2 diabetes.
