Anacor Completes End-of-Phase2 Meeting With FDA On AN2728 Ointment - Quick Facts

(RTTNews) - Anacor Pharmaceuticals (ANAC) announced Thursday that it has successfully completed an End-of-Phase 2 meeting with the United States Food and Drug Administration or 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% - 20% of infants and young children.

"We have reached agreement with the FDA on all major parameters for the Phase 3 trials, which we expect to initiate in the next 60 days," said David Perry, Chief Executive Officer.

"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," said David Perry.

Anacor said it will conduct two multi-center, 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 or ISGA score of 2 ("mild") or 3 ("moderate"). The ISGA is a 5-point scale from 0 ("clear") to 4 ("severe").

The company stated that 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.

The firm noted that it 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 3 trial will have the option to roll into the long-term safety trial until about 500 subjects are enrolled. 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.