Akesis Pharmaceuticals Inc., an emerging diabetes drug-development company, has filed its first Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for its lead product candidate AKP-020, a novel vanadium compound that is expected to show considerable potential as a treatment for patients with type II diabetes. This IND submission follows the pre-IND filing in early July, from which the company received constructive feedback from the FDA.
Upon FDA approval of the IND application and protocol, Akesis intends to initiate a phase IIa open-label, single arm US clinical trial in diabetic patients for AKP-020. The trial will be performed by dgd Research Inc. 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. Subject to the timing of obtaining the required FDA approval, the company is currently projecting the trial to begin in the fourth quarter of 2007.
"The IND filing is an important milestone for the company, and we continue to stay on track with our development timeline," said Jay Lichter, president and chief executive officer of Akesis.
Earlier this year, Akesis initiated 28-day renal-focused safety and toxicology studies in rats and dogs for AKP-020. The company will report these results as soon as feasible once they become available.
AKP-020 is the product designation for a novel vanadium compound otherwise known as bis (ethylmaltolato) oxovanadium (IV), or BEOV. The compound was invented and developed by University of British Columbia researchers Chris Orvig, professor of chemistry and pharmaceutical sciences, and John McNeill, Ph.D., professor and dean emeritus, pharmaceutical sciences, and is licensed exclusively to Akesis Pharmaceuticals. Professors Orvig and McNeill, who are experts in the study of metal chemistry and pharmaceutical sciences, helped to advance the BEOV programme through phase I clinical trials. They also are members of the Akesis Scientific Advisory Board.