AOBiome, a biotech focused on producing biologic, bacteria-based therapies, reports positive results for a Phase IIb trial of its lead topical therapy candidate for treating skin itching and atopic dermatitis or eczema.
The Cambridge, Massachusetts-based company has developed a therapy based on ammonia oxidizing bacteria, which is currently at Phase II for treatment of skin itching, eczema, acne and rosacea. These bacteria produce both nitric oxide and nitrite, which have anti-inflammatory, vasodilatory and anti-infective properties. Previous work has shown they can reduce levels of inflammatory cytokines IL-4, IL-5, IL-13, and IL-31.
Despite being a common problem, 7–12% of all adults and children in the U.S. suffer from eczema, available treatments to target symptoms such as intense itching are only of limited efficacy. AOBiome is aiming to apply the anti-inflammatory and anti-infective properties of its therapy to solve this problem.
In the current double blind, randomized, placebo controlled, Phase IIb trial, 547 patients with mild-to-moderate eczema and skin itching symptoms were enrolled. They used a spray containing the treatment, which is currently known as B244, or placebo, twice a day for 28 days.
The primary endpoint for the trial was a significant reduction in average Worst Itch Numeric Rating Scale (WI-NRS) score and the secondary endpoints included Investigator Global Assessment (IGA) of eczema symptoms and Eczema Area and Severity Index (EASI) score, as well as assessing the number of participants achieving an improvement of four points or more on the WI-NRS scale.
The trial, which was carried out across 56 sites in the U.S., met both primary and secondary endpoints. The average WI-NRS score was improved by 34.3% versus placebo. At the beginning of the study, the average score was 8 or more and this reduced by an average of 2.8 points in the treatment group versus 2.1 in the placebo group.
Two doses of the treatment were trialed, 27.7% of participants treated with a low dose and 29.3% of the high dose group achieved a 75% improvement in EASI score (EASI75) compared with 15.8% of the placebo group. Similarly, 26.2% and 21.7% of the high and low-dose groups, respectively, achieved ‘clear’ or ‘almost clear’ results with a two point or higher improvement in IGA score (indicating success) versus 12.3% of the placebo group.
The researchers observed no major side effects. Some minor adverse effects, such as an increase in itching on application, occurred in a few participants, but quickly resolved.
“Current therapies often do not work or come with significant side effect risks. The efficacy observed for this topical spray after only 4 weeks is exciting for both clinicians and patients. An effective non-steroidal, non-injectable therapy without black box warnings or laboratory monitoring is pretty much the holy grail of unmet need in dermatology,” said Jonathan Silverberg, Associate Professor of Dermatology at George Washington School of Medicine and Health Services.