Anacor Pharmaceuticals' ($ANAC) topical treatment for eczema came through with positive results in a pair of Phase III trials, propelling the biotech's shares upward and setting the stage for an FDA application next year.
The treatment, crisaborole, succeeded in two studies on more than 1,500 patients in total, significantly beating out placebo in clearing up eczema after 29 days. In top-line efficacy data, both trials met their primary endpoint of significantly increasing the number of patients who were eczema-free or nearly so on the Investigator's Static Global Assessment scale, with a minimum improvement of two grades for about 32% of patients. And on a secondary goal, roughly half of volunteers treated with crisaborole in both studies were clear or almost clear regardless of where they started on the scale.
Anacor said the treatment's side effects were largely mild, with 4.4% of patients reporting pain at the site of application and 3% coming down with respiratory infections. None of the patients crisaborole experienced any serious adverse events, the company said.
Now Anacor is planning to file an FDA application for crisaborole in the first half of 2016, seeking approval to treat mild-to-moderate eczema in children and adults.
The Phase III success sent the Palo Alto, CA, company's shares up as much as 60% on Monday morning, as investors cheered crisaborole's efficacy and speculated that a larger drugmaker might swoop in and buy Anacor. With its latest clinical success, the biotech's market cap is around $3.7 billion.
Elsewhere in eczema, partners Regeneron ($REGN) and Sanofi ($SNY) are working through Phase III with the injected treatment dupilumab, which analysts say could be a blockbuster anti-inflammatory. And Celgene ($CELG) is in the midst of Phase II development in hopes of getting the oral Otezla, already approved for arthritis and psoriasis, cleared to treat eczema.
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