Anacor Pharmaceuticals 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.
SOURCE Anacor Pharmaceuticals