AOBiome Therapeutics, a clinical stage biotech company focused on topical therapies for systemic inflammatory conditions, announced pivotal positive results in the Phase 2b trial of its B244 trial for both pruritus (itch) and the appearance of atopic dermatitis (eczema).
B244 is a patented topical formulation incorporating a single strain of beneficial ammonia oxidizing bacteria (AOB), Nitrosomonas eutropha D23. According to the company, it is designed to repopulate the skin microbiome with AOBs normally found on the body but frequently stripped away by most soaps.
The trial enrolled 547 patients with mild to moderate-appearing atopic dermatitis and moderate to severe itch. According to the company, the trial met all primary and secondary endpoints, showing B244 significantly reduced itch, reduced overall disease severity, improved skin clearance and improved health-related quality of life measures at four weeks compared with the placebo.
More specifically, B244 reduced patients' mean Worst Itch Numeric Rating Scale score by 34.3% from the baseline, and improved secondary endpoints related to appearance versus the placebo group. B244 was well-tolerated with no serious adverse events; treatment-related adverse events were low in incidence, mild in severity and transient. The most common event was application site pruritus (0.8%).
"The favorable profile demonstrated in this study for safety and efficacy on both skin lesions and itch fills important unmet needs for first line therapies in atopic dermatitis," said Jonathan Silverberg, M.D., Ph.D., associate professor of dermatology at George Washington School of Medicine and Health Services. "Current therapies often do not work or come with significant side effect risks.
"The efficacy observed for this topical spray after only four 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."
"Topical biotherapeutic drug development is challenging, as traditional factors like PK/PD and animal models are not informative," said Todd Krueger, AOBiome's president and CEO. "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 B24 while minimizing the high placebo rate that often plagues these types of studies. We are excited about moving toward a Phase 3 trial."