Novel boron-based ointment safe in treating atopic dermatitis in children

AN2728 ointment 2%, a novel boron-based small-molecule ointment, might be effective for the treatment of patients ages 2 years and older with mild-to-moderate atopic dermatitis, according to research presented during a late-breaking research session.

Researcher Zoe Diana Draelos, MD, and colleagues evaluated systemic exposure, pharmacokinetics and safety of AN2728 ointment 2% twice a day for 28 days in 34 children and adolescents with mild-to-moderate atopic dermatitis.

Patient age and minimum percent treatable body surface areas (%BSA) affected were used to define three patient cohorts, including 2 years to 5 years, 6 years to 11 years and 12 years to 17 years. Investigator’s Static Global Assessment (ISGA), signs/symptoms score and %BSA affected were used to measure disease severity.

Sixty-five percent of patients reached ISGA scores of clear or almost clear at day 29, with 47% of the patients having scores of clear of almost clear, including a 2-grade improvement from baseline.

AD symptoms, including pruritus, erythema, lichenification, excoriation and exudation showed marked reduction from baseline. As early as day 5, patients showed up to 60% improvement in mean pruritus scores. After 4 weeks, mean %BSA affected declined by an average of 78%.

Application site reactions, generally mild or moderate in severity, were the most common treatment-related adverse events and resolved spontaneously. Draelos reported that one patient, aged 2 years, was withdrawn at day 13 because of application site pain.

Low AN2728 blood levels were displayed in pharmacokinetic results.

“The application of AN2728 topical ointment 2% to larger body surface areas did produce a higher plasma exposure level but did not correlate with greater adverse events,” Draelos said. “Thus, the study was effective in demonstrating safety of the product.”

“These results confirm the safety of AN2728 and as a result, this project will move forward and may provide eventually another useful drug, a molecule for dermatologists to use in atopic dermatitis,” she concluded.

For more information:

Draelos, ZD. F037: Late‐breaking Research: Pediatrics & Clinical/Therapy. Presented at: American Academy of Dermatology Annual Meeting; March 20-24, 2015, San Francisco.

Disclosure: Draelos reports financial ties with Abbott Laboratories, AGI Dermatics, Allergan, Altana, Amgen, Amneal Pharmaceuticals, Anacor Pharmaceuticals, Anterios, AstraZeneca, Avon Products, Bayer, Bayer Consumer Healthcare Pharmaceuticals, Beiersdorf, Boots, Botaneco, Colgate-Palmolive, Dial, DSE Pharmaceuticals, Elizabeth Arden, Galderma Laboratories, GlaxoSmithKline, Glenmark Generics, Guthy-Renker, Helix-BioMedix, Johnson & Johnson Consumer Products Company, Kao Brands, Kimberly Clark, L’Oreal USA, La Roche-Posay, Laboratoire Pharmatceutique, Lexington International, Living Proof, MakuCell, Maruho, Medicis, Merck & Co., Merz Pharmaceuticals, Neocutis, Neutrogena, Niadyne, Novartis Pharmaceuticals, Nuskin, Nycomed Amersham, Otsuka Pharmaceutical Co., Pacific Biosciences, Paddock, Perrigo Company, Pfizer, Pharmaderm, Procter & Gamble, Promius Pharma, Quinnova Pharmaceuticals, Ranbaxy Laboratories Limited, Reckitt Benckiser (España), Signum Biosciences, SkinMedica, Stiefel, Symrise, Syneron, Taro Pharm, Teva Pharmaceuticals USA, Tolmar, TriaBeauty, Valeant Pharmaceuticals International, Vichy Laboratories and XOMA.