Legacy Healthcare Announces Completion of Enrollment of RAAINBOW Phase 2/3 Trial for the Treatment of Pediatric Alopecia Areata (AA)

EPALINGES, Switzerland, Oct. 6, 2021 /PRNewswire/ -- Legacy Healthcare, a clinical-stage biopharmaceutical company focused on developing novel drugs for autoimmune and inflammatory diseases, today announced that it has completed the enrollment of a Phase 2/3 trial of Coacillium (LH-8), an investigational drug for the treatment of moderate to severe scalp alopecia areata (i.e., baldness of 25% and above) in pediatric population.  As of today, there is no treatment approved for this autoimmune disease, with psychologically devastating consequences, especially for children.

The RAAINBOW study is an interventional Phase 2/3, double-blind, vehicle-controlled, randomized, multi-center trial, evaluating the efficacy and safety of Coacillium cutaneous solution in children and adolescents with moderate (25% to 50% baldness) to severe (>50% baldness) Alopecia Areata. The primary endpoint is the relative change in scalp alopecia areata severity score (SALT) from baseline value, to be assessed after 24 weeks of treatment. The treatment period is followed by 24-weeks treatment-free evaluation period in order to evaluate, among other endpoints, the potential persistence of the effect obtained with the investigational drug after treatment interruption.

"Alopecia Areata being a progressive disease in many cases, it is paramount to treat patients as early as possible. However, all drugs in late-stage development are restricted to patients with over 50% baldness only; children, who suffer severely from the disease, are also excluded. Coacillium is the only drug-candidate which can be administered to all patients, including the ones who are still early in the disease, before baldness spreads and becomes difficult to treat; in addition, its excellent safety profile makes it today the only option in late-stage development for children," said Saad Harti, CEO.

Primary endpoint is expected in Q1 2022 and full-trial data in Q3 2022. An initial blinded analysis was published on November 2020 (DOI: 10.1016/j.jisp.2020.04.009)

About Coacillium (LH-8)

Coacillium (LH-8) is an investigational topical drug. Among the actives present in Coacillium, various flavonoids, polyphenols and methylxanthines have been associated, enabling a pleiotropic mechanism (i.e., multiple targets), to simultaneously reverse immuno-inflammatory reactions and their deleterious consequences on hair follicles and adjacent dermal tissues.

About Legacy Healthcare

Legacy Healthcare is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates with unparallel safety to address the needs of fragile patients (children, cancer patients, chronic condition sufferers, the elderly) with autoimmune and inflammatory diseases who lack satisfactory treatment options. The company has a multi-staged portfolio of drug candidates. For additional information, please visit www.legacyhealthcare.ch

Disclaimer

This press release contains forward-looking statements which are based on current assumptions and forecasts of Legacy Healthcare management. Known and unknown risks, uncertainties, and other factors could lead to material differences between the forward-looking statements made here and the actual development, in particular Legacy Healthcare's results, financial situation, and performance. Readers are cautioned not to put undue reliance on forward-looking statements, which speak only of the date of this communication. Legacy Healthcare disclaims any intention or obligation to update and revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Legacy Healthcare Contact

Saad HARTI; [email protected]

SOURCE LEGACY HEALTHCARE