Late breaking news presentation slides
Coacillium is a multi-target botanical drug composed of Allium cepa,
Citrus limon, Theobroma cacao and Paullinia cupana.
Its multiple components have shown to act positively on both hair follicle cycling and endothelial cells activation, two relevant targets for alopecia areata, while sparing immunity.
Coacillium was granted several patents globally.
Coacillium efficacy and safety
Coacillium cutaneous solution is among the first drugs which benefit/risk profile supports use in moderate AA patients, allowing prevention of disease progression, in addition to severe alopecia areata, including children.
In a phase 2-3 registration study ( RAAINBOW) in moderate and severe alopecia areata in children and adolescents, Coacillium cutaneous solution was superior to placebo after 24 weeks of treatment, both in terms of clinical efficacy and improvement of quality of life.
Most Coacillium-responders experienced sustained improvement during the 24 weeks treatment-free follow-up period of the study, indicating a paradigm shift in the treatment of alopecia areata.
Coacillium was well tolerated, and no serious adverse event was reported
We believe that this drug is among the first to show sustained remission off-treatment in an autoimmune-mediated disease, without immune-altering side-effects.
In 2004, both the US FDA and the European Medicines Agency have put in place the Botanical Drug regulatory pathway, enabling the development of innovative drugs from one or several full-plants’ extracts.
The approval process of Botanical Drugs is similar to chemical drugs and they are required to meet equivalent efficacy and safety criteria.
Provided they are based on plants known to be safe for human use, Botanical Drugs represent optimal treatments of chronic conditions where patients need to be exposed for a long period to the drug substance.
Moreover, in contrast to mono-compound synthetic drugs, the multiple components of plants may address multiple biological targets simultaneously.
This is what Coacillium, the first-ever multi-plant botanical drug has achieved.
Legacy Healthcare is a pioneer of this promising field.
Coacillium is our first “New Botanical Entity” (NBE) a designation we have coined.
Our goal is to become a global leader for the development of NBEs, in collaboration with think-alike researchers and financing partners.
We intend to leverage the power of AI to turn phytopharmacology, biology, chemotaxonomy knowledge etc. into transformative botanical drugs for the treatment of autoimmune and inflammatory chronic diseases.