Anacor Pharmaceuticals (NASDAQ:ANAC) announced today that the first patient has been enrolled in the Phase 3 trial of AN2728, a novel boron-based phosphodiesterase-4 (PDE-4) inhibitor, for the topical treatment of mild-to-moderate atopic dermatitis. Atopic dermatitis is a chronic rash characterized by inflammation and itch and affects approximately 10% - 20% of infants and young children. The Phase 3 trial consists of two multi-center, double-blind, vehicle-controlled studies which will enroll approximately 750 subjects per study who will be randomized 2:1 (active:vehicle). Both studies will be conducted at multiple sites and enroll subjects ages two years and older with mild-to-moderate atopic dermatitis, defined as an Investigator Static Global Assessment (ISGA) score of 2 (“mild”) or 3 (“moderate”). The ISGA is a 5-point scale from 0 (“clear”) to 4 (“severe”). AN2728 Ointment, 2% will be applied twice daily for 28 days. The primary efficacy endpoint will be treatment success at Day 29, defined as an ISGA of “Clear” or “Almost Clear” with at least a 2-grade improvement from baseline. Secondary endpoints will include an ISGA of “Clear” or “Almost Clear” at Day 29 as well as time to treatment success. Safety evaluation will include reported adverse events, safety laboratory tests, and vital signs. Subjects who complete either Phase 3 study will have the option to enroll in a long-term safety trial to evaluate the safety of intermittent use of AN2728 Ointment, 2% for up to 12 months. At least 100 subjects will be enrolled for 12 months and at least 300 subjects will be enrolled for 6 months, during which time subjects will be treated as needed under the direction of the investigator. 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 discovered eight compounds that are currently in development. Its two lead product candidates are topically administered dermatologic compounds — Kerydin (tavaborole), an antifungal for the treatment of onychomycosis, and AN2728, an anti-inflammatory PDE-4 inhibitor for the treatment of atopic dermatitis and psoriasis. In addition to its two lead programs, Anacor has discovered three other wholly-owned clinical product candidates — AN2718 and AN2898, which are backup compounds to Kerydin and AN2728, respectively, and AN3365, an antibiotic for the treatment of infections caused by Gram-negative bacteria. Anacor has also discovered three other compounds that have been out-licensed for further development — one is licensed to Eli Lilly and Company for the treatment of an animal health indication, the second compound, AN5568, also referred to as SCYX-7158, is licensed to Drugs for Neglected Diseases initiative, or DNDi, for human African trypanosomiasis (HAT, or sleeping sickness) and the third compound is licensed to GlaxoSmithKline, LLC for development in tuberculosis. Anacor also has a pipeline of other internally discovered topical and systemic boron-based compounds in development. For more information, visit http://www.anacor.com. Forward-Looking Statements This release contains forward-looking statements, including statements regarding our Phase 3 clinical development of AN2728. 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 clinical trials, risks of unforeseen side effects and risks related to regulatory approval of new drug candidates. Reference should be made to Anacor's Annual Report on Form 10-K for the year ended December 31, 2013 filed with the Securities and Exchange Commission under the heading "Risk Factors". 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.
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