Anacor Pharmaceuticals today announced positive clinical trial results for its lead phosphodiesterase-4 (PDE4) inhibitor, AN2728, a novel topical anti-inflammatory compound derived from Anacor's boron chemistry platform. These results were obtained from a multi-center, Phase 2b, randomized, double-blind, dose-ranging, bilateral trial comparing AN2728 ointment, 0.5% and 2.0%, applied once or twice daily, to vehicle in 145 patients with mild-to-moderate plaque-type psoriasis. Compared to those treated with vehicle, psoriasis plaques treated with AN2728 achieved greater improvement in the Overall Target Plaque Severity Score (OTPSS) in a significantly higher proportion of patients after six weeks in the 2.0% AN2728 twice daily dosing group (P <0.001), which was the primary endpoint of the trial. A dose-response was also observed across the four dosing groups for this outcome. Additionally, of those plaques treated for 12 weeks with 2.0% AN2728 twice daily, 54 percent achieved complete or near complete clearance with at least a two-grade improvement from their baseline severity score.
“We believe that the safety and efficacy results observed in all three trials allow us to differentiate AN2728 from the topical corticosteroids and vitamin D analogs which are limited by their long-term safety and/or their tolerability profile. We look forward to initiating a Phase 3 study for AN2728 in mid-2011.”
"This is the third Phase 2 trial that we have completed with AN2728 and we are pleased that the results are consistent with the statistically significant efficacy that we've seen in each of the previous trials," said David Perry, Chief Executive Officer of Anacor. "We believe that the safety and efficacy results observed in all three trials allow us to differentiate AN2728 from the topical corticosteroids and vitamin D analogs which are limited by their long-term safety and/or their tolerability profile. We look forward to initiating a Phase 3 study for AN2728 in mid-2011."
The randomized, double-blind, vehicle-controlled, multicenter, dose-ranging trial evaluated the safety and efficacy of AN2728 ointment, 0.5% and 2.0%, applied once or twice daily for 12 weeks for the treatment of mild-to-moderate plaque-type psoriasis. Taking advantage of the characteristically symmetric location of psoriasis plaques on the body, the trial was designed to have each of the 145 patients randomly assigned to apply AN2728 ointment, 0.5% or 2.0%, once or twice daily to one target plaque and the vehicle ointment to a similar target plaque usually on the opposite side of the body. Treatments were generally well tolerated with no serious adverse events reported. Anacor intends to present full results from this Phase 2b trial at an appropriate future scientific meeting.
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