Anacor Pharmaceuticals Announces GSK Has Initiated Two Phase 2 Trials of GSK ‘052 in Complicated Urinary Tract Infections

PALO ALTO, Calif.--(BUSINESS WIRE)-- Anacor Pharmaceuticals (NASDAQ:ANAC) announced today that GlaxoSmithKline (GSK) has initiated two separate Phase 2b trials of GSK 2251052, or GSK ‘052 (formerly referred to as AN3365), in complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

GSK ‘052 is a novel boron-based, systemic antibiotic being developed for the treatment of infections caused by Gram-negative bacteria. GSK ‘052 specifically targets the bacterial enzyme leucyl-transfer RNA synthetase, or LeuRS, which is required for protein synthesis. The inhibition of protein synthesis leads to termination of cell growth and cell death. Since there are no commercially available antibiotics that target LeuRS, there is no known pre-existing bacterial resistance to the target. Preclinical and Phase 1 studies suggest that GSK '052 is a promising drug candidate for the treatment of infections caused by a broad range of Gram-negative bacteria, including E. coli, K. pneumoniae, Citrobacter spp., S. marcescens, P. vulgaris, Providentia spp., Pseudomonas aeruginosa and Enterobacter spp. as well as other pathogens responsible for both cUTI and cIAI.

“Increasing resistance to existing antibiotics has created a critical need for novel therapies for the treatment of infections caused by Gram-negative bacteria,” said David Perry, Chief Executive Officer of Anacor Pharmaceuticals. “We believe GSK ‘052 has the potential to be the first new class of antibiotic specifically targeting Gram-negative infections in over 30 years.”

Anacor licensed this compound to GSK in July 2010 under the companies' ongoing research and development collaboration. Under the collaboration, GSK is responsible for the management and costs of these Phase 2b trials as well as all further development and any resulting commercialization of GSK ‘052. Anacor is eligible to receive future development milestones up to $69 million, commercial milestones up to $175 million, and double-digit tiered royalties with the potential to reach the mid-teens on annual net sales.

The Phase 2b trial in cUTI is a multi-center, randomized, double-blind, multi-dose study of the safety, tolerability, and efficacy of GSK ‘052 in the treatment of adult subjects with febrile lower cUTI and acute pyelonephritis. GSK ‘052 will be compared to imipenem-cilastatin, an antibiotic commonly used to treat serious cUTI. GSK anticipates enrolling approximately 200 patients.

The Phase 2b trial in cIAI is a multi-center, randomized, double-blind, multi-dose study of the safety, tolerability and efficacy of GSK ‘052 in the treatment of cIAI in adults. GSK ‘052 will be compared to meropenem, an IV therapy that is approved for use in the treatment of subjects with cIAI. GSK anticipates enrolling approximately 200 patients.

About Anacor Pharmaceuticals

Anacor is a biopharmaceutical company focused on discovering, developing and commercializing novel small-molecule therapeutics derived from its boron chemistry platform. Anacor has five compounds in clinical development, all of which have been internally discovered, including its three lead programs: AN2690, a topical antifungal for the treatment of onychomycosis; AN2728, a topical anti-inflammatory PDE-4 inhibitor for the treatment of psoriasis and atopic dermatitis; and GSK 2251052, or GSK ‘052 (formerly referred to as AN3365), a systemic antibiotic for the treatment of infections caused by Gram-negative bacteria, which has been licensed to GlaxoSmithKline under the companies' research and development agreement. In addition, Anacor is developing AN2718 as a topical antifungal product candidate for the treatment of onychomycosis and skin fungal infections, and AN2898 as a topical anti-inflammatory product candidate for the treatment of psoriasis and atopic dermatitis. For more information visit http://www.anacor.com.

Forward-Looking Statements

This press release may contain forward-looking statements that relate to future events including the development and commercialization of GSK ‘052, and more specifically, the enrollment and conduct of the Phase 2b trials. These forward looking statements involve known and unknown risks, uncertainties and other factors that could cause actual levels of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements, including risks related to enrollment and successful completion of our trials, risk of unforeseen side effects and risks related to regulatory approval of new drug candidates. These statements reflect the views of Anacor as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this press release.



CONTACT:

Anacor Pharmaceuticals
DeDe Sheel, 650-543-7575
Investor Relations and Corporate Communications
[email protected]

KEYWORDS:   United States  North America  California

INDUSTRY KEYWORDS:   Health  Biotechnology  Clinical Trials  Pharmaceutical  Research  Science

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