Results of Phase 1 Absorption Trial Released
PALO ALTO, Calif.--(BUSINESS WIRE)-- 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.
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.”
About Anacor Pharmaceuticals
Anacor is a biopharmaceutical company focused on discovering, developing and commercializing novel small-molecule therapeutics derived from its boron chemistry platform. Anacor has discovered and is developing five clinical compounds, including its three lead programs: AN2690, a topical antifungal for the treatment of onychomycosis; AN2728, a topical anti-inflammatory PDE-4 inhibitor for the treatment of psoriasis; and GSK 2251052, or GSK ‘052 (formerly referred to as AN3365), a systemic antibiotic for the treatment of infections caused by Gram-negative bacteria, which has been licensed to GlaxoSmithKline under the companies' research and development agreement. In addition, Anacor is developing AN2718 as a topical antifungal product candidate for the treatment of onychomycosis and skin fungal infections, and AN2898 as a topical anti-inflammatory product candidate for the treatment of psoriasis and atopic dermatitis. For more information visit http://www.anacor.com.
This press release may contain forward-looking statements that relate to future events including the development and commercialization of AN2728, and more specifically, the enrollment and conduct of the AN2728 Phase 2b and potential Phase 3 programs. These forward looking statements involve known and unknown risks, uncertainties and other factors that could cause actual levels of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements, including risks related to enrollment and successful completion of our trials, risk of unforeseen side effects and risks related to regulatory approval of new drug candidates. These statements reflect the views of Anacor as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this press release.
DeDe Sheel, 650-543-7575
Director, Investor Relations and Corporate Communications
KEYWORDS: United States North America California
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical Research Science