AOBiome Therapeutics, a leading clinical-stage biotechnology company focused on inflammation, announced the completion of enrollment in its Phase 2b clinical trial of pruritus (itching) associated with atopic dermatitis. This study builds on previous positive clinical trial results associated with the evaluation of its lead product candidate B244, a topical biotherapeutic, in patients with atopic dermatitis (eczema) in a 122-subject Phase 2a clinical trial in adults and a 28-subject Phase 1b clinical trial in pediatric patients with 28 patients. The Company believes that its current study, with 547 subjects, is by far the largest clinical trial ever conducted with a topical biotherapeutic.
Based on phase 2a and 1b efficacy signals, a double-blind, randomized, placebo-controlled, multicenter phase 2b dose-finding study was initiated to evaluate the efficacy, safety, and tolerability of B244 live topical spray twice daily for 28 days for the treatment of pruritus in 547 adults with a history of mild to moderate atopic dermatitis. Patients were enrolled in this study at 56 sites in 25 states. The primary endpoint of the study was the mean change on the Worst Itch Numeric Rating Scale (WI-NRS) from baseline to week 4. Secondary endpoints included the proportion of subjects with an improvement of ≥ 4 points on WI-NRS from baseline to week 4. The Itch NRS is a validated instrument for measuring itch intensity. In addition, the Investigator Global Assessment (IGA) and Eczema Area and Severity Index (EASI) endpoints for atopic dermatitis were recorded. Due to COVID -19, patient and site personnel safety was of paramount importance. AOBiome implemented a comprehensive risk mitigation plan to ensure this safety. Despite the pandemic, sufficient patients were enrolled in the study to meet the original target for completion. The company expects the first data in early February 2022.
“Itch remains the primary unmet medical need for patients with atopic dermatitis. Itch therapies tend to work slowly and B244’s rapid onset could prove very helpful to patients who need faster relief. Recent findings have shown that injectables are not as safe as originally hoped and now require black box warnings. A solution with this sort of safety profile positions B244 as a first-in-line therapy for itch which could be a big win for patients” commented President & CEO, Todd Krueger. “We look forward to announcing results from this study early in 2022.”
In the United States, 7% of adults and 12% of children under 18 years of age suffer from eczema and associated pruritus.¹ Of these, about two-thirds suffer from mild to moderate cases. Patients with mild to moderate atopic dermatitis may present with moderate to severe pruritus that is inadequately treated by available therapies.
“B244’s downregulation of multiple cytokines such as IL-4, 5, 13, and 31 supports real hope that there will be an effective solution to help stop the itch-scratch cycle in both adult and younger populations” stated Klaus Dugi, non-executive Director of AOBiome and Adjunct Professor of Medicine at Heidelberg University in Germany. “Current therapies for atopic dermatitis focus on appearance, while pruritus is the primary complaint patients would like to see resolved. B244’s innovative nature represents a potential novel therapeutic opportunity to safely address the medical needs of these patient populations.”
Additional information regarding this and AOBiome’s other clinical programs may be found at www.clinicaltrials.gov.
