Anacor Announces Positive Results From Trial In Psoriasis Patients
Anacor Pharmaceuticals announced results from a Phase 2a clinical trial of AN2728, an investigational topical anti-inflammatory drug, in patients with psoriasis. The study met its primary endpoint and all secondary endpoints.
In 69 percent of patients, the area treated with AN2728 scored better at the end of therapy than the area treated with the vehicle ointment, compared with six percent of patients in whom the vehicle-treated areas were superior. These results were statistically significant (p<0.001). No drug-related safety issues were reported.
"The results of this study suggest that AN2728 can effectively treat psoriasis in a clinical setting. In addition, plaques treated with AN2728 continued to improve over the course of the 28 days of therapy, suggesting longer-term treatment may have an even greater effect," said Karl R. Beutner, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Anacor. "These results are encouraging for both AN2728 and our entire anti-inflammatory program."
AN2728 is a novel boron-containing small molecule that inhibits the release of pro-inflammatory cytokines including TNF-alpha, IL-12, and IL-23, known mediators of the inflammation associated with psoriasis.
The randomized, double-blind, placebo-controlled trial was designed to evaluate the safety and efficacy of an ointment containing a 5% concentration of AN2728 with patient self-application. Patients with psoriasis commonly have similar areas of psoriasis on their left and right, or front and back sides. The study took advantage of this bilateral characteristic of psoriasis. In this trial, 35 patients treated one of their areas of psoriasis with AN2728 ointment, and a matching area on the opposite side with vehicle alone, twice a day for four weeks.
In addition to this Phase 2a study, two Phase 1b dose-ranging trials have investigated the effects of concentration and formulation on drug efficacy. These earlier trials demonstrated significant activity even at a 0.5% concentration of AN2728, the lowest concentration tested.