AOBiome Therapeutics has reported that its Phase IIb clinical trial of B244 for pruritus (itch) and appearance in atopic dermatitis (eczema) met all its primary and secondary endpoints.

The randomised, double-blind, multicentre, placebo-controlled, dose selection trial analysed the safety, efficacy and tolerability of B244 live biotherapeutic topical spray administered twice a day for 28 days to manage pruritus linked with atopic dermatitis.

Carried out at 56 sites in 25 states of the US, it enrolled 547 adult patients with a history of moderate-to-severe pruritus and mild-to-moderate atopic dermatitis (eczema). 

The mean change in Worst Itch Numeric Rating Scale (WI-NRS) from baseline to the fourth week was the trial’s primary endpoint while the proportion of participants with ≥4 point improvement in WI-NRS from baseline for the same time period was included as the secondary endpoint. 

The itch WI-NRS scale is a self-reported tool to determine the intensity of the itch. 

Furthermore, the trial also assessed Investigator Global Assessment (IGA) and Eczema Area and Severity Index (EASI) for atopic dermatitis as endpoints. 

Positive findings revealed

Findings demonstrated that B244 substantially lowered itch, cut down overall severity of the disease, boosted skin clearance and enhanced health-associated quality of life measures at four weeks versus placebo.  

In addition, the treatment with B244 lowered the mean WI-NRS score by 34.3% from a baseline WI-NRS score above eight.

Secondary endpoints linked to appearance also attained statistical significance. 

Subjects in the high and low dose arms of B244 attained EASI-75 success of 29.3% and 27.7%, respectively versus 15.8% in the placebo arm.

Nearly 26.2% and 21.7% of participants who received high and low doses of B244, respectively had IGA success compared to 12.3% in those treated with placebo.

In the trial, B244 was found to be safe and well-tolerated without any serious adverse event reported.

A patented, topical and intranasal formulation, the B244 platform generates nitric oxide on deployment. B244 is a signalling molecule that can aid in inflammation and vasodilation regulation. 

AOBiome president and CEO Todd Krueger said: “Topical biotherapeutic drug development is challenging, as traditional factors like PK/PD and animal models are not informative. 

“We were able to isolate the immunomodulation of B244 across Il-4, 5, 13 and 31 and then select a dose and design a delivery regimen that highlighted the benefits of B244 while minimising the high placebo rate that often plagues these types of studies.” 

In April 2018, the company started a Phase II trial analysing the safety, tolerability and efficacy of its Ammonia Oxidizing Bacteria product candidate to treat episodic migraine.