DISEASES

Anacor Pharmaceuticals Announces GSK Has Initiated Two Phase 2 Trials Of GSK '052 In Complicated Ur

Author: Dr. Lee
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Time: 2011/6/24 16:48:49

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 complicatedurinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

GSK '052 is a novel boron-based, systemic antibioticbeing 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.

Source:
Anacor Pharmaceuticals

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