Feb 4 2011
Anacor Pharmaceuticals (NASDAQ:ANAC) announced today that the first patient has been dosed in a Phase 2b trial of AN2728, a topical anti-inflammatory product candidate for the treatment of psoriasis. Psoriasis is a chronic inflammatory skin disease that affects approximately 7.5 million people in the United States and over 100 million people worldwide. AN2728 is a boron-based small-molecule compound which inhibits the activity of phosphodiesterase-4 (PDE4), thereby reducing the production of TNF-alpha, IL-12, IL-23 and other pro-inflammatory cytokines that are the precursors of the inflammation associated with psoriasis.
“With the encouraging results from the Phase 1 absorption trial and the timely dosing of the first patient in this Phase 2b trial, we are on track with our plan to develop a novel, safe and effective topical therapy for the millions of patients who suffer from psoriasis.”
The Phase 2b trial is designed to evaluate the safety and efficacy of AN2728 in patients with mild to moderate plaque-type psoriasis and will be conducted under anticipated Phase 3 conditions. This double-blind, randomized, vehicle-controlled trial plans to enroll 60 patients with mild to moderate plaque-type psoriasis who will be randomized to 2% AN2728 topical ointment or vehicle in a 2:1 ratio. Patients will apply the ointment twice daily for 12 weeks. Results are anticipated in the second half of 2011. Given its size, the trial is not designed to demonstrate statistical differentiation of AN2728 from vehicle, but to inform the size and design of the two planned pivotal Phase 3 trials for AN2728.
Anacor also announced today the results of its Phase 1 absorption trial for AN2728 which evaluated the topical pharmacokinetics, systemic safety, and local tolerability in 16 healthy volunteers. In this double-blind trial, 2% AN2728 ointment or vehicle ointment was applied twice daily for seven days to 10% body surface area (BSA) in one cohort and 35% BSA in another. No serious or severe adverse events were observed and no clinically meaningful laboratory or ECG abnormalities were found. Pharmacokinetic profiles showed very low systemic exposure. In summary, the trial demonstrated that 2% AN2728 topical ointment was well-tolerated and provided a substantial margin of safety for both acute and chronic effects when applied twice daily to healthy volunteers.
"AN2728 has reached its key endpoints in the seven clinical trials we have conducted thus far," said David Perry, Chief Executive Officer of Anacor Pharmaceuticals. "With the encouraging results from the Phase 1 absorption trial and the timely dosing of the first patient in this Phase 2b trial, we are on track with our plan to develop a novel, safe and effective topical therapy for the millions of patients who suffer from psoriasis."
SOURCE Anacor Pharmaceuticals
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