Anacor Pharmaceuticals commences patient dosing in AN3365 Phase I clinical study

Anacor Pharmaceuticals today announced that it has dosed the first patient in a Phase I clinical study for AN3365, a novel boron-based, small-molecule drug candidate in development for the treatment of hospital infections caused by Gram-negative bacteria. The study will evaluate the safety, tolerability and pharmacokinetics of AN3365 in healthy volunteers.

AN3365 targets the bacterial enzyme leucyl tRNA synthetase. Preclinical studies suggest that AN3365 could be a novel approach for the treatment of Gram-negative infections, including E. coli, K. pneumoniae and Enterobacter spp. AN3365 is being developed under an alliance agreement with GlaxoSmithKline (GSK), and the initiation of Phase I studies releases a milestone payment to Anacor of $6 million.

“We are pleased with the rapid pace of our joint discovery activities, which have resulted in our second major milestone payment from GlaxoSmithKline in 2009,” said Jacob J. Plattner, Ph.D., Senior Vice President of Research at Anacor Pharmaceuticals. “By leveraging the novel approaches we’ve pioneered in the field of boron chemistry, and the expertise from GlaxoSmithKline, we were able to move this program from discovery to clinical development in just two years since signing the collaboration.”

The randomized, double-blind, placebo-controlled, dose-escalation study is expected to enroll more than 80 healthy volunteers. Participants in the Phase I study will receive AN3365 in single or multiple doses for treatment durations of up to 14 days.

Alliance with GSK

In October 2007, Anacor and GSK entered into a worldwide strategic alliance for the discovery, development and commercialization of novel medicines for viral and bacterial diseases. The collaboration provides GSK access to Anacor’s proprietary boron-based chemistry for use against four selected targets. Under the terms of the agreement with GSK, Anacor retains responsibility for the development of AN3365, and other boron-containing, small molecules through clinical proof of concept, at which point GSK will have an exclusive option to license each compound for further development and commercialization on a worldwide basis. Contingent on achieving certain milestones, Anacor is eligible to receive discovery, development, regulatory and commercial milestones ranging up to $252 million and $331 million for each product candidate. If GlaxoSmithKline exercises its option at the proof of concept stage, Anacor will receive tiered double digit royalties, which are dependent on sales achieved.