B244 was tested in a very large 547 patient Phase 2b study looking at both appearance and itch associated with atopic dermatitis. The company focused on mild to moderate disease (appearance) but moderate to severe itch. These patients are typical difficult to treat and have poor outcomes (see paper). These clinical trial results where also published in the Lancet (see paper).
The results of this study showed a clinically meaningful and statistically relevants effect after 4 short weeks (most competitive drugs were tested for 8 to 16 weeks) for both appearance and for itch.
The ability to treat moderate to severe itch quickly without needing moderate to severe drugs, which are either expensive or have a risky safety profile, presents B-244 with a unique market opportunity.
These benefits were provided by a topical biologic spray with an extremely advantageous safety profile. Less than 1% of ANY adverse event was seen and there were not serious adverse events at all. B244 had roughly the same safety as the placebo which was essentially saltwater (PBS). This is a huge benefit given that most treatments have safety profiles that require either black box warnings, excessive site pain, high incidences of folliculitis. This make B244 an ideal first line treatment option so patients don’t escalate to more costly or risky solutions.
The company plans on enrolling patients in 2025 in its Phase 3 trials with results reading out in 2027.