SAN FRANCISCO and PALO ALTO, Calif., March 3 /PRNewswire/ -- Anacor Pharmaceuticals, a privately-held pharmaceutical company developing novel agents for inflammatory and infectious diseases, today presented positive data from Phase 1 clinical and preclinical studies of AN0128, the company's novel topical compound currently in Phase 2 clinical trials for atopic dermatitis (AD). These studies demonstrated that AN0128 was well tolerated at the site of application and indicated that further study was warranted.
"While atopic dermatitis is fundamentally a disease of the immune system, one of the primary triggers for the disease is the presence of Staph aureus on the skin," said Dr. Karl Beutner, chief medical officer at Anacor. "Therefore, physicians often treat AD with a combination of antibiotics and anti-inflammatories. AN0128 holds the promise of treating both components of the disease with a single compound."
Anacor scientists and collaborators presented six posters detailing the preclinical and clinical studies of AN0128 at the American Academy of Dermatology Annual Meeting. The following highlights the conclusions of these posters:
-- In in vitro assays, AN0128 was shown to be active against microorganisms commonly found colonizing the skin that may be involved in the pathology of atopic dermatitis, including bacteria that are resistant to other antibiotics; -- AN0128 inhibits the release of pro-inflammatory cytokines without affecting the normal immune response. This activity results in potent activity in pre-clinical models of inflammation. AN0128 can prevent the release of IL-1beta and TNFalpha, pro-inflammatory cytokines implicated in the progression of atopic dermatitis, without altering the innate immune response; -- Systemic exposure after topical administration of AN0128 is minimal; -- No systemic toxicity has been observed with AN0128 at any dose tested; and -- The most common side effect observed in the Phase 1 trial was transient irritation at the application site.
"AN0128 is a single molecule that has both antibacterial and anti-inflammatory properties," said Dr. Jacob Plattner, senior vice president of Anacor. "Unlike other classes of antibiotics, some of which are thought to have mild anti-inflammatory action, AN0128 exhibits potent anti-inflammatory activity through the inhibition of pro-inflammatory cytokines, including TNFalpha. This combination gives the compound the potential to treat a number of diseases."
AN0128 Phase 2 Program
Anacor is currently enrolling patients in a double-blind, placebo-controlled Phase 2 study of AN0128 for the treatment of atopic dermatitis. The study will evaluate 100 patients at multiple U.S. centers. Anacor also has conducted Phase 1/2 trials of AN0128 in acne and psoriasis, and will evaluate further studies in these indications after atopic dermatitis Phase 2 data becomes available later this year.
About Atopic Dermatitis
Atopic Dermatitis (AD) is a chronic rash characterized by inflammation and itchiness. The disease, which affects approximately 15 million patients in the U.S., most commonly appears in children (20% of U.S. children are affected) and can persist into adulthood. Patients with atopic dermatitis frequently have problems with heavy colonization and infection with bacteria, most commonly Staph aureus, because of defects in their innate immunity. Colonization with staph may fuel the inflammatory response in their skin. Current AD treatments attempt to reduce inflammation and itchiness to maintain the protective integrity of the skin. Combinations of antibiotics, antihistamines, topical corticosteroids and topical immunomodulators (TIMs) such as picrolimus and tacrolimus are the current standard of care.
However, the current standard of care has limited utility because of lack of efficacy and/or side effects. At least 80% of AD patients are colonized with Staph aureus against which AN0128 has potent activity. Traditionally these infections can be treated with oral antibiotics. However in recent years bacterial antibiotic resistance has become a growing problem. AN0128, with both anti-bacterial and anti-inflammatory activity, could provide a dual approach to treat atopic dermatitis.
About Anacor Pharmaceuticals.
Anacor, a privately held, clinical-stage pharmaceutical company, is developing novel product candidates for inflammatory and infectious diseases based on its proprietary, small-molecule, boron-based chemistry. Initially, Anacor is focusing development efforts on dermatological disorders with a product candidate in Phase 2 clinical trials for atopic dermatitis and another in Phase 2 trials for onychomycosis, a fungal infection of fingernails and toenails that affects as much as 14% of the general U.S. population.
Anacor PharmaceuticalsCONTACT: David Perry, Chief Executive Officer of Anacor Pharmaceuticals,+1-650-739-0700; or Daryl Messinger of WeissComm Partners, Inc.,+1-415-999-2361, or daryl@weisscommpartners.com, for Anacor Pharmaceuticals
Web site: http://www.anacor.com/
