Crisaborole topical ointment, 2%, a novel non-steroidal topical anti-inflammatory PDE-4 inhibitor, is our lead product development candidate for the potential treatment of mild-to-moderate atopic dermatitis and psoriasis.
About Atopic Dermatitis
Atopic dermatitis is a chronic rash characterized by inflammation and itching. Based on available sources, we believe approximately 18 to 25 million people in the United States suffer from this condition, including between 8 and 18% of infants and children.
Current Atopic Dermatitis Therapies
Current atopic dermatitis treatments attempt to reduce inflammation and itchiness to maintain the protective integrity of the skin. Combinations of antibiotics, antihistamines, topical corticosteroids and topical immunomodulators are the current standard of care. While not approved by the FDA for treatment of atopic dermatitis, ultraviolet light has also been used to treat this disease.
Our Product Candidate: Crisaborole
Crisaborole topical ointment, 2%, is an investigational non-steroidal topical anti-inflammatory PDE-4 inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis. Crisaborole is a novel boron-containing small molecule and, although the specific mechanism of action is not yet completely defined, we believe that crisaborole inhibits PDE-4 in target cells, which reduces the production of pro-inflammatory cytokines thought to cause the signs and symptoms of atopic dermatitis.
In July 2015, we announced top-line results from our two Phase 3 pivotal studies of crisaborole in patients with mild-to-moderate atopic dermatitis. In each of the two Phase 3 pivotal studies, crisaborole achieved statistically significant results on all primary and secondary endpoints and demonstrated a safety profile consistent with previous studies. In October 2015, we announced top-line results from our long-term safety study of crisaborole in patients with mild-to-moderate atopic dermatitis. In the long-term safety study, crisaborole was found to be well-tolerated and demonstrated a safety profile consistent with that seen in the Phase 3 pivotal studies when used intermittently for up to 12 months. In March 2016, the U.S. Food and Drug Administration accepted for review Anacor’s New Drug Application seeking approval of crisaborole for the potential treatment of mild-to-moderate atopic dermatitis in children and adults. The Prescription Drug User Fee Act goal date for the completion of the FDA’s review is January 7, 2017.
For more information about our clinical trials for crisaborole, follow this link: http://www.clinicaltrials.gov/ct2/results?term=an2728.