Anacor Pharmaceuticals announced Monday results from two Phase 3 studies involving Crisaborole Topical Ointment, a non-steroidal topical medication for treating mild to moderate cases of atopic dermatitis in both children and adults, detailing the product as achieving statistically significant results to prove both efficacy and safety.
Atopic dermatitis is a chronic condition characterized by an inflamed rash and severe itching. Anacor believes that there are around 18 to 25 million people suffering from atopic dermatitis in the United States. Out of that number, 80 to 90 percent are dealing with mild to moderate severity of the disease. Adults can have atopic dermatitis but the condition is most commonly reported in children, with about 8 to 18 percent of the country's infants and children affected.
A number of treatments already exist to address atopic dermatitis but many are ineffective. Topical corticosteroids are one of these treatments but they cannot be utilized for long-term use because of certain side effects. Topical calcineurin inhibitors are approved as non-steroidal treatment but they too have to be used with caution because of the potential cancer risk they bring.
Paul L. Berns, CEO and chairman for Anacor, is pleased with the results of the Phase 3 studies, thankful to clinical investigators and patients and their families for making the studies possible.
"We believe there is a significant unmet medical need for a novel non-steroidal topical anti-inflammatory treatment option for the patients who are affected by mild-to-moderate atopic dermatitis," he said, adding that Anacor has plans of filing a New Drug Application in the early parts of 2016 for crisaborole.
The studies involved more than 750 patients each, all aged 2 years old and above and rated with Investigator Static Global Assessment (ISGA) scores of either 2 (mild) or 3 (moderate). Patients were randomly chosen to receive crisaborole or vehicle twice a day for a total of 28 days. Treatment is considered a success if on the 29th day a patient is gauged with an ISGA score of 0 (clear) or 1 (almost clear), with a minimum improvement of two points from baseline.
As for safety results, they were consistent with studies previously carried out. The most common side effects were pain in the application site and infections in the upper respiratory tract. Serious adverse events were also not reported in patients given crisaborole.
A long-term safety study is being conducted to further evaluate safety in intermittent use of the medication for up to a year. A minimum of 100 and 300 patients part of the Phase 3 studies are also participating in this study, enrolled for 12 and 6 months respectively. Results should be made available at the end of the year, according to Anacor.
Photo: Niels Olson | Flickr
