Alopecia areata is a chronic autoimmune disease where your immune system mistakenly attacks hair follicles, creating random, disfiguring, hair loss. While the disease is not life-threatening, it is documented to have negative impact on mental health, such as causing depression, anxiety, and social phobia. Celebrities such as Rickie Lake and Jada Pinkett have been open about their struggles with alopecia and how it has affected their lives. “The more conversations and awareness about this disease, the better, so people do not feel as alone,” says Saad Harti, CEO and founder of Legacy Healthcare, a pharmaceutical company on a mission to develop a drug for alopecia areata, safe enough to be taken early in the disease, both in terms of severity and age, both to prevent disease progression to a severe stage, and chronicity.
Great advance has been achieved with the recent approval of two oral Janus Kinase inhibitors (which most commonly go by “JAK Inhibitors”) for the treatment of alopecia in adults and adolescents. However, they are restricted to patients with the most severe form of the disease because of their safety profile. JAK Inhibitors come indeed with black box warnings from the FDA, which is the most stringent safety warning for marketed drugs. In addition, their discontinuation causes rapid disease relapse, requiring life-long treatment, notwithstanding the safety warnings.
“In most patients, the disease starts with a moderate form, so it is essential to address the disease early, to prevent its progression to a more severe stage, which becomes more difficult to treat,” says Harti. “Also, alopecia is a complex auto-immune disease, so targeting it with multiple molecules could give a better chance to treat it. The multiple secondary metabolites full-plant extracts precisely offer that chance, provided you discover the proper plants combination.” says Harti.
By using plants known safe for human use, and which chemical composition could potentially address several druggable target of the disease, Legacy Healthcare may have discovered a safe and efficacious drug, which can be used in the long run.
Patients also prefer botanical drug to address chronic diseases. In a recent survey conducted by Harris Poll on behalf of Legacy Healthcare, American adults mentioned they would prefer a botanical drug over a synthetic/biologic prescription drug to treat a chronic illness, assuming both are considered effective and equally priced. “For the treatment of chronic diseases, and there are many, the botanical drug pathway looks promising” says Harti.
Legacy Healthcare’s RAAINBOW study, a Phase 2/3 clinical trial, was conducted in children and adolescents with moderate to severe alopecia areata. The trial had positive top line results which were announced earlier this year and shared with the medical community this month in a late breaking news presentation at the annual congress of the EADV, in Berlin.
“We couldn’t be more excited about what was presented,” says Harti. “Coacillium was superior to placebo and well tolerated, with no drug-related serious adverse events.”
The presentation at the EADV Congress highlighted a unique and game-changing finding from the RAAINBOW study. Coacillium showed sustained remission after treatment discontinuation. “To our knowledge, Coacillium is among the first drug to show sustainable remission off-treatment in an autoimmune disease, along with a clean safety profile” says Harti.
Legacy Healthcare is determined to bring to patients and physicians the first cutaneous drug to treat alopecia areata. The marketing authorization application for Coacillium has been filed through the European Medicines Agency. Based on early observations, Legacy Healthcare is exploring the extension of topical and oral Coacillium to other immuno-dermatology and inflammatory diseases.
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