PALO ALTO, Calif., Nov. 9 /PRNewswire/ -- Anacor Pharmaceuticals, a privately held pharmaceutical company, announced today that it has begun dosing patients in its phase 2b study of AN0128, a novel topical anti-inflammatory drug candidate for atopic dermatitis (AD), a disease affecting approximately 15 million Americans. AD is characterized by a chronic rash with accompanying inflammation and infection. It is most common in children, with an estimated 20 percent affected by the condition.
“Because AN0128 effectively targets inflammation in a topical preparation, it is a promising treatment against AD,” said Dr. Karl Beutner, chief medical officer at Anacor. “This phase 2b study will give us important information about the safety and effectiveness of the treatment in children -- a group that is disproportionately affected by AD.”
The multi-center, randomized, placebo-controlled study plans to enroll 200 patients between the ages of 2 and 17 years with moderate atopic dermatitis, and researchers will assess efficacy using a six-point (clear, almost clear, mild, moderate, severe, very severe) investigator static global assessment (ISGA) scale. Patients will receive AN0128 or a placebo cream twice a day for 6 weeks.
Details of Discovery of AN0128 Published
Anacor also announced the publication of a journal article describing the discovery of AN0128. The paper, titled “Identification of a novel boron-containing antibacterial agent (AN0128) with anti-inflammatory activity, for the potential treatment of cutaneous diseases” has been e-published in Bioorganic & Medicinal Chemistry Letters. In the article, lead author Steven Baker and his team describe the process of identifying a compound using Anacor’s proprietary boron chemistry platform, modifying that compound and screening the 17 variations for their ability to kill bacteria. The researchers then assessed the four most potent compounds for its anti-inflammatory effects, eventually selecting AN0128 for additional clinical development.
About AN0128 Clinical Program
AN0128 inhibits the release of pro-inflammatory cytokines, including TNF- alpha, without affecting the normal immune response. It has demonstrated potent anti-inflammatory activity in pre-clinical models of inflammation. This activity gives the compound the potential to treat a number of diseases. Anacor has also conducted Phase 1/2 trials of AN0128 in acne and psoriasis and will evaluate further studies in these indications.
Past studies of AN0128 have shown promise, particularly in moderate AD. Results from a 103-patient Phase 2a study showed that 51 percent of patients with atopic dermatitis treated with AN0128 were judged to have skin that was “clear” or “almost clear,” as compared with 37 percent of patients treated with the vehicle treatment, and an analysis of patients with more severe disease found an even greater difference between AN0128 and the vehicle cream.
Atopic Dermatitis Treatment
Current AD treatments attempt to reduce inflammation and itchiness to restore normal appearance and function of the skin. Combinations of antibiotics, antihistamines, topical corticosteroids and topical immunomodulators (TIMs) such as picrolimus and tacrolimus are the current standard of care.
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 AN2690 in Phase 2 trials for onychomycosis, a fungal infection of nails and nailbeds. A second product candidate, AN0128, is in Phase 2 clinical trials for atopic dermatitis.
Anacor Pharmaceuticals
CONTACT: David Perry, Chief Executive Officer of Anacor Pharmaceuticals,+1-650-739-0700; or Brian Reid of WeissComm Partners, Inc.,+1-703-402-3626, or breid@weisscommpartners.com, for Anacor Pharmaceuticals
Web site: http://www.anacor.com//