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Anacor Pharmaceuticals Announces Positive Results From Phase 2 Trial of AN2728

Anacor Pharmaceuticals (NASDAQ: ANAC) today announced positive results from a Phase 2 safety, pharmacokinetics (PK), and efficacy trial of its boron-based phosphodiesterase-4 (PDE-4) inhibitor, AN2728, in adolescents (ages 12 – 17) with mild-to-moderate atopic dermatitis, a chronic rash characterized by inflammation and itching.

“Data from our first study of AN2728 in adolescents with atopic dermatitis are promising, with 35% of patients achieving an ISGA score of ‘clear' or ‘almost clear' with a minimum 2-grade improvement. This is the first study in which we have evaluated the effect of treating all of a patient's atopic dermatitis and measured the improvement using the ISGA scale, the same scale used by the FDA to evaluate the most recently approved topical treatments for atopic dermatitis,” said David Perry, Anacor's Chief Executive Officer. “In addition, AN2728 demonstrated a promising safety profile in a younger patient population, which is essential given that this disease primarily affects children.”

The Phase 2 open-label study enrolled 23 adolescent patients, with mild-to-moderate atopic dermatitis involving 10-35% of treatable body surface area (BSA). Mild-to-moderate atopic dermatitis was defined as an Investigator Static Global Assessment (ISGA) score of 2 (“mild”) or 3 (“moderate”). The ISGA is a 5-point scale from 0 (“clear”) to 4 (“severe”). Patients were instructed to apply AN2728, 2% ointment twice daily for 28 days. The primary endpoints were an assessment of safety and tolerability based on the frequency and severity of systemic and local adverse events (AE's) as well as the pharmacokinetic profile. Secondary endpoints included assessment of change in ISGA score as well as individual signs and symptoms of atopic dermatitis.

Efficacy

74% of patients achieved an ISGA score of 0 (“clear”) or 1 (“almost clear”) after four weeks of treatment. 35% of patients achieved an ISGA score of 0 (“clear”) or 1 (“almost clear”) with a minimum 2-grade improvement after four weeks of treatment. In addition to the improvement in ISGA score, treatment with AN2728 also led to improvement in all of the individual signs and symptoms of atopic dermatitis. Safety and Tolerability

AN2728 was generally safe and well-tolerated with the most common AE's being application site reactions. Pharmacokinetic Profile

Overall blood levels in adolescents were low and were similar to those previously observed in adults after adjusting for percent BSA treated. Development Plan for AN2728 in Atopic Dermatitis

We are currently conducting a Phase 2 dose-ranging study in adolescents with atopic dermatitis and expect results from this study in the first half of 2013. We plan to initiate a Phase 2 study in children under the age of 12 in the first half of 2013. We plan to initiate Phase 3 studies in atopic dermatitis pending the results of the two Phase 2 studies described above. About Atopic Dermatitis and Current Treatment Options

Posted-In: News FDA

 

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