Anacor Pharmaceuticals (NASDAQ:ANAC) today announced positive results from its maximal use systemic exposure (MUSE) study of its boron-based phosphodiesterase-4 (PDE-4) inhibitor, AN2728, in pediatric and adolescent patients with atopic dermatitis. The results of this study demonstrate that AN2728 Ointment, 2% appears to be safe, well-tolerated, and efficacious when applied twice daily to patients, ages two to 18 years with atopic dermatitis affecting a very large percentage of their body surface area.
“The results of this study are very encouraging. Atopic dermatitis primarily affects children and has a big impact on the quality of life of patients and their families. Atopic dermatitis is primarily treated with topical agents, and physicians are constantly looking for alternatives to steroids. AN2728 has the potential to become a widely used treatment,” said Adelaide A. Hebert, M.D., Professor and Director of Pediatric Dermatology at the University of Texas Medical School at Houston.
“This was an important study as it represents the first time we have treated patients in the 2 – 11 year age group, an age range that encompasses most atopic dermatitis patients,” said David Perry, Chief Executive Officer of Anacor Pharmaceuticals. “We are pleased to see the efficacy and safety profile demonstrated in this study, as it represents the final significant hurdle before holding an End of Phase 2 meeting with the FDA.”
AN2728 MUSE Study
The multi-center, open label study enrolled 34 patients, ages two to 18 years with mild-to-moderate atopic dermatitis with a mean involvement of 48% of total 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 (or their caregivers) were instructed to apply AN2728 Ointment, 2% twice daily for 28 days.
Primary endpoints included 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 when AN2728 Ointment, 2% is applied under maximal use conditions to pediatric and adolescent patients with atopic dermatitis. Secondary endpoints included descriptive assessments of improvement in the severity and extent of disease based on the ISGA, signs and symptoms of atopic dermatitis and treatable percent of body surface area.