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Key clinical point: A topical biotherapeutic spray containing live ammonia-oxidizing bacteria (B244) was safe and meaningfully improved pruritus at both high and low dose levels in patients with mild-to-moderate atopic dermatitis (AD) and moderate-to-severe pruritus.
Major finding: At week 4, treatment with low dose (optical density [OD] at 600 nm 5.0) and high dose (OD at 600 nm 20.0) spray vs vehicle showed a significant treatment effect (P = .015 and P = .014, respectively), with a 34% mean reduction in Worst Itch Numeric Rating Scale scores from baseline in both treatment groups. No serious adverse events were reported.
Study details: This multicenter phase 2b randomized controlled trial included 547 adult patients with mild-to-moderate AD and moderate-to-severe pruritus who were randomly assigned to receive low dose B244, high dose B244, or vehicle for 4 weeks.
Disclosures: This study was funded by AOBiome Therapeutics. Some authors reported ties with various organizations, including AOBiome. Six authors declared being current or former employees of or holding stock or stock options in AOBiome.
Source: Silverberg JI et al. Efficacy and safety of topically applied therapeutic ammonia oxidising bacteria in adults with mild-to-moderate atopic dermatitis and moderate-to-severe pruritus: A randomised, double-blind, placebo-controlled, dose-ranging, phase 2b trial. EClinicalMedicine. 2023 (May 16). doi:10.1016/j.eclinm.2023.102002
Key clinical point: A topical biotherapeutic spray containing live ammonia-oxidizing bacteria (B244) was safe and meaningfully improved pruritus at both high and low dose levels in patients with mild-to-moderate atopic dermatitis (AD) and moderate-to-severe pruritus.
Major finding: At week 4, treatment with low dose (optical density [OD] at 600 nm 5.0) and high dose (OD at 600 nm 20.0) spray vs vehicle showed a significant treatment effect (P = .015 and P = .014, respectively), with a 34% mean reduction in Worst Itch Numeric Rating Scale scores from baseline in both treatment groups. No serious adverse events were reported.
Study details: This multicenter phase 2b randomized controlled trial included 547 adult patients with mild-to-moderate AD and moderate-to-severe pruritus who were randomly assigned to receive low dose B244, high dose B244, or vehicle for 4 weeks.
Disclosures: This study was funded by AOBiome Therapeutics. Some authors reported ties with various organizations, including AOBiome. Six authors declared being current or former employees of or holding stock or stock options in AOBiome.
Source: Silverberg JI et al. Efficacy and safety of topically applied therapeutic ammonia oxidising bacteria in adults with mild-to-moderate atopic dermatitis and moderate-to-severe pruritus: A randomised, double-blind, placebo-controlled, dose-ranging, phase 2b trial. EClinicalMedicine. 2023 (May 16). doi:10.1016/j.eclinm.2023.102002
Key clinical point: A topical biotherapeutic spray containing live ammonia-oxidizing bacteria (B244) was safe and meaningfully improved pruritus at both high and low dose levels in patients with mild-to-moderate atopic dermatitis (AD) and moderate-to-severe pruritus.
Major finding: At week 4, treatment with low dose (optical density [OD] at 600 nm 5.0) and high dose (OD at 600 nm 20.0) spray vs vehicle showed a significant treatment effect (P = .015 and P = .014, respectively), with a 34% mean reduction in Worst Itch Numeric Rating Scale scores from baseline in both treatment groups. No serious adverse events were reported.
Study details: This multicenter phase 2b randomized controlled trial included 547 adult patients with mild-to-moderate AD and moderate-to-severe pruritus who were randomly assigned to receive low dose B244, high dose B244, or vehicle for 4 weeks.
Disclosures: This study was funded by AOBiome Therapeutics. Some authors reported ties with various organizations, including AOBiome. Six authors declared being current or former employees of or holding stock or stock options in AOBiome.
Source: Silverberg JI et al. Efficacy and safety of topically applied therapeutic ammonia oxidising bacteria in adults with mild-to-moderate atopic dermatitis and moderate-to-severe pruritus: A randomised, double-blind, placebo-controlled, dose-ranging, phase 2b trial. EClinicalMedicine. 2023 (May 16). doi:10.1016/j.eclinm.2023.102002