Anacor Pharma completes end-of-phase II meeting with US FDA for treatment of mild-to-moderate atopic dermatitis with AN2728

California Saturday, March 01, 2014, 15:00 Hrs  [IST]

Anacor Pharmaceuticals has successfully completed an End-of-Phase II meeting with the United States Food and Drug Administration (FDA) for the topical treatment of mild-to-moderate atopic dermatitis with AN2728 Ointment, 2%, a novel boron-based phosphodiesterase-4 (PDE-4) inhibitor. Atopic dermatitis is a chronic rash characterized by inflammation and itch and affects 10 to 20 per cent of infants and young children. "We have reached agreement with the FDA on all major parameters for the phase III trials, which we expect to initiate in the next 60 days," said David Perry, chief executive officer of Anacor Pharmaceuticals. "Based on the clinical studies conducted to date, we believe AN2728 has the potential to offer patients and physicians a safe and effective topical treatment option for mild-to-moderate atopic dermatitis, providing a potential alternative to treating with topical corticosteroids or topical calcineurin inhibitors." Anacor will conduct two multi-centre, double-blind, placebo-controlled trials with approximately 750 subjects per trial randomized 2:1 (active:vehicle). Both studies will be conducted at multiple sites and enroll subjects ages two years and up with mild-to-moderate atopic dermatitis. Mild-to-moderate atopic dermatitis is 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. Anacor will also initiate a long-term safety trial to evaluate the safety of intermittent use of AN2728 Ointment, 2% for up to 12 months. Subjects who complete either phase III trial will have the option to roll into the long-term safety trial until approximately 500 subjects are enrolled. At least 100 subjects will be enrolled for 12 months and at least 300 subjects will be enrolled for six months, during which time subjects will be treated as needed under the direction of the investigator. The following four clinical studies of AN2728 in mild-to-moderate atopic dermatitis support the basis for our phase III study design: AD-202 - a double-blind, bilateral, vehicle-controlled study in 25 adults in which 52% of AN2728-treated lesions achieved total or partial clearance, defined as an Atopic Dermatitis Severity Index (ADSI) score &#60 2 versus 16% for vehicle after 28 days of twice-daily treatment. The ADSI score is the sum of the severity scores of five clinical features (erythema, pruritus, exudation, excoriation and lichenification) from 0 (none) to 3 (severe) for each feature, for a total score of 0 to 15. Anacor originally reported the results of this study on December 12, 2011. AD-203 - an open-label, whole-body study in 23 adolescents in which 74% of patients achieved an ISGA score of 0 ("clear") or 1 ("almost clear") after four weeks of twice-daily treatment. 35% of patients achieved an ISGA score of 0 ("clear") or 1 ("almost clear") with a minimum 2-grade improvement after four weeks of twice-daily treatment. Anacor originally reported the results of this study on December 10, 2012. AD-204 - a double-blind, bilateral, dose-ranging study in 86 adolescents in which twice daily treatment with AN2728 Ointment, 2% demonstrated the greatest improvement in treating atopic dermatitis lesions. 62% of lesions in this treatment group achieved total or partial clearance, as defined by the ADSI. Anacor originally reported the results of this study on March 21, 2013. AD-102 - a maximal use systemic exposure (MUSE) study in patients, ages two to 17 years with atopic dermatitis affecting a large percentage of their body surface area. 47% of patients achieved an ISGA score of 0 ("clear") or 1 ("almost clear") with a minimum 2-grade improvement after four weeks of twice-daily treatment with AN2728 Ointment, 2%. 65% of patients achieved an ISGA score of 0 ("clear") or 1 ("almost clear") after four weeks of twice-daily treatment with AN2728 Ointment, 2%. Anacor originally reported results of this study on November 12, 2013. In addition to these four studies, AN2728 has demonstrated safety and efficacy in 14 other phase I and phase II studies. In all studies, AN2728 was generally considered safe and well-tolerated. Most adverse events were mild and largely unrelated to study drug. Anacor is a biopharmaceutical company focused on discovering, developing and commercializing novel small-molecule therapeutics derived from its boron chemistry platform.