AOBiome’s 547 subject Phase 2b trial for Treatment of Pruritus (Itch) Associated with Atopic Dermatitis (Eczema) successfully completes its recruitment goal
AOBiome’s 547 subject Phase 2b trial for Treatment of Pruritus (Itch) Associated with Atopic Dermatitis (Eczema) successfully completes its recruitment goal |
| [16-November-2021] |
| CAMBRIDGE, Mass., Nov. 16, 2021 /PRNewswire/ -- AOBiome, a leading clinical-stage biotechnology company focusing on inflammation, announced completion of enrollment in its Phase 2b clinical trial in pruritus (itch) associated with atopic dermatitis. This trial is based on previous positive clinical trial results related to the investigation of its lead product candidate, B244, a live topical biotherapeutic, in patients with atopic dermatitis (eczema) in a 122 subject Phase 2a clinical trial in adults as well as a 28 subject Phase 1b clinical trial in pediatric patients with 28 patients. The company believes that its current 547 subject study is the largest Clinical Trial ever run using a live topical biotherapeutic by a wide margin.
Based on its Phase 2a and 1b efficacy signals, a double blind, randomized, placebo controlled, multicenter, Phase 2b dose selection 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. 56 sites across 25 states enrolled patients in this trial. The primary endpoint for the study was mean change in Worst Itch Numeric Rating Scale (WI-NRS) from baseline to week 4. Secondary endpoints included the proportion of subjects with ≥ 4 point improvement in WI-NRS from baseline to week 4. The Itch NRS is a validated, self-reported instrument for measurement of itch intensity. Additionally, endpoints of Investigator Global Assessment (IGA) and Eczema Area and Severity Index (EASI) for Atopic Dermatitis were captured. Due to COVID-19, patient and site staff safety have been of paramount concern. AOBiome has implemented a comprehensive risk mitigation plan to ensure such safety. The trial enrolled enough patients to hit its original completer target despite the pandemic. The company expects top line data by 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” said 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 the age of 18 years suffer from eczema and associated pruritus.¹ Of these, approximately two thirds have mild to moderate cases. Patients with mild to moderate atopic dermatitis can exhibit moderate to severe pruritus which is inadequately addressed 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” said 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. About B244 About AOBiome Therapeutics, Inc. Contacts: ¹ Hanifin J, Reed M. A Population-Based Survey of Eczema Prevalence in the United States. Dermatitis. 2007;18(2):82-91. doi:10.2310/6620.2007.06034.
SOURCE AOBiome |
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