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.

To evaluate potential disease relapse, patients were followed for a period of 6 months after treatment discontinuation. Almost all patients whose alopecia areata improved during the 6-months treatment with Coacillium kept improving after treatment discontinuation, suggestive of a direct long-term action of Coacillium on the physiopathological process causing alopecia areata.

No serious adverse events (AEs) were reported. One adverse event was considered as definitely related to Coacillium (acute scalp and face eczema), and three probably or possibly related. All AEs were cutaneous, mild or moderate, and transient. The excellent safety of the drug observed in the trial was consistent with observations from previous studies.  Coacillium is also being evaluated in persistent chemotherapy induced alopecia.

“Thanks to its excellent safety profile, Coacillium is – to our knowledge – the first drug candidate to be developed first in children, for a disease which also affects adults. With these new data, we observe that not only Coacillium treatment works in most patients who use it, but its benefit is maintained after treatment discontinuation – at least during the period of observation of 6 months. This would represent a significant change in treatment paradigm, for patients, physicians and stakeholders” said Saad Harti, Chief Executive Officer of Legacy Healthcare. “We look forward to bringing this potential new treatment to the ones who suffer from alopecia areata, and people who care for them”.

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