AOBiome Therapeutics, Inc. is initiating a Phase 2b clinical trial of its lead product candidate, B244, in pruritus associated with atopic dermatitis.

B244 is a first-in-class, topical formulation of beneficial ammonia oxidizing bacteria that is delivered as a spray twice daily for 28 days.  AOBiome's AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB. Once deployed, AOB produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

The Phase 2b dose selection study will enroll 576 adults with a history of mild-to-moderate atopic dermatitis.  Patient enrollment has begun, with approximately 50 US sites across 27 states participating in this trial.  Primary efficacy endpoint and key secondary efficacy endpoint will include mean change in Worst Itch Numeric Rating Scale (WI-NRS) from baseline to week 4 and proportion of subjects with ≥4 point improvement in WI-NRS from baseline to week 4, respectively.   Additionally, endpoints of Investigator Global Assessment (IGA) and Eczema Area and Severity Index (EASI) for Atopic Dermatitis will be captured. 

The new study is based on positive results in a Phase 2a clinical trial in adults, as well as a Phase 1b clinical trial in pediatric patients.

The adult trial was a double-blind, placebo-controlled, multicenter, Phase 2a study designed to assess safety and efficacy in 122 patients 18 years and older with mild-to-moderate pruritus associated with atopic dermatitis.  Patients receiving the investigational drug achieved a statistically significant improvement in their pruritus compared with patients receiving placebo (p value = 0.01) after two weeks.  In addition, 23 percent of patients receiving the drug achieved at least a 4-point improvement (out of 10) utilizing the visual analog scale (VAS) for pruritus, versus 6 percent of patients receiving placebo. B244 was very well tolerated and side effects of the active were equal to that of the placebo.  This was consistent with all previous trials the company has completed with this drug.  Typical itch drugs take significantly longer to show improvement, the Company notes.

The pediatric trial was an open-label, single-dose level, multicenter, Phase 1b study of the B244 topical formulation, administered twice daily and was designed to assess its safety and tolerability in 28 pediatric patients aged 2 to 17 years with mild-to-moderate atopic dermatitis over a 28-day period.  The drug was very well tolerated.  Fully 28 percent of patients achieved at least a two-point (out of 5) improvement on the ITCHMAN pruritus scale at week four and 64 percent achieved at least a 1-point improvement.

"There is a significant medical need for new therapies to treat both adults and children with itch associated with atopic dermatitis.  In younger populations, itch can be the primary complaint and can exacerbate the severity of disease through an itch-scratch-lesion worsening cycle.  Our safety profile and rapid onset of efficacy has led us to focus on pruritus as the lead indication in our next clinical trial," says President & CEO, Todd Krueger, in a news release. "We look forward to announcing results from this study in 2021."  

"The potential beneficial effect of B244 on atopic dermatitis and its associated pruritus is multi-pronged.  Pruritus relief may be mediated through an immunomodulatory mechanism of action.  Pre-clinical results have shown that the bacteria exert an anti-inflammatory effect on certain markers associated with itch.  Company studies have also shown the potential antimicrobial mechanism of action that contribute to the reduction of pathogenic bacteria infecting the established skin lesions," adds Board of Director, Dr. Annalisa Jenkins, MBBS MRCP. "Furthermore, current therapies for pruritus can cause local side effects such as stinging, burning, and thinning of skin, especially in pediatric patients. B244's innovative nature represents a novel therapeutic opportunity to safely address the medical needs of patients.”