Legacy Healthcare, a clinical-stage biopharmaceutical company today announced positive results from the RAAINBOW phase 2/3 randomized placebo-controlled trial evaluating Coacillium 22.25% cutaneous solution in children and adolescents with moderate and severe alopecia areata, a debilitating autoimmune condition causing disfiguring scalp hair loss. Coacillium achieved the primary efficacy endpoint of the study, as well as key secondary endpoints. After 6 months treatment, Coacillium was statistically significantly superior compared to placebo in relative change in Severity of Alopecia Tool (SALT) score. The proportion of subjects achieving at least a 40% relative reduction in SALT score was statistically significantly superior in the drug group.
With one oral drug recently approved for severe alopecia areata in adults, and more in progress, interest and understanding of the disease and its impact have increased. Among key learnings is the need for treatments that can be used early enough in the course of the disease, while it is still Moderate, to prevent, delay, or reverse the progression to a Severe stage, as well as treatments that are safer and better tolerated, and treatments which discontinuation does not result in rapid disease relapse.
Coacillium is the first and only drug candidate for alopecia areata in children and adolescents with both moderate and severe forms of the disease. RAAINBOW phase 2/3 trial data showed that patients presenting moderate alopecia areata improved under Coacillium treatment, while the control group of patients receiving placebo worsened to a more severe stage of the disease.