Swiss biopharma Legacy Healthcare has received regulatory guidance from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to conduct a single Phase 3 trial of its botanical drug candidate Cinainu for alopecia areata.
Key Takeaways from PMDA Feedback
- Single Phase 3 Trial Approved: PMDA confirmed that one well-designed Phase 3 trial will suffice to support regulatory approval in Japan—if successful.
- Inclusive Patient Population: The trial will include children, adolescents, and adults with moderate to severe alopecia areata.
- Justification: Although Japanese patients were not part of the prior RAAINBOW Phase 2/3 study, the agency accepted a new Japanese cohort for this pivotal trial.
Cinainu: What the Data Says
Published Results from the RAAINBOW Phase 2/3 Trial (British Journal of Dermatology, July 16, 2025):
- Promoted significant hair regrowth
- Improved quality of life scores
- Sustained therapeutic effects even after discontinuation
- No immunosuppression-related adverse events
- Well-tolerated across age groups, including children and adolescents
“Beyond its efficacy in regrowing scalp hair, Cinainu treats this autoimmune disease without immunosuppression-related side effects—this is a first,”
- Saad Harti, Founder & CEO, Legacy Healthcare.
Addressing a Critical Unmet Need in Alopecia Areata
Alopecia Areata (AA): An Autoimmune Burden
- Characterized by non-scarring hair loss
- Caused by immune dysregulation, including JAK/IL-8 signaling
- Significantly impacts patients' psychological and social wellbeing
Limitations of Current AA Treatments:
- Existing oral JAK inhibitors (3 approved) are only suitable for severe cases in adults and adolescents
- Many patients relapse upon treatment discontinuation
- Lack of safe options for children and moderate-stage patients
About Cinainu
A First-in-Class Botanical Drug for AA
- Form: Topical solution
- Mechanism:
- Reduces IL-8 and adhesion molecules (E-selectin, ICAM-1)
- Restores anti-apoptotic protein Bcl-2 levels
- Increases scalp collagen and Langerhans cell density - Safety:
- No immunosuppressive effects
- Safe across trials with 700+ patients up to 12 months - Patent Protection: Valid through 2043
- Also Studied In:
- Androgenetic alopecia
- Chemotherapy-induced alopecia
About Legacy Healthcare
- Location: Switzerland
- Focus: Prescription botanical drugs derived from plants known safe for human use
- Therapeutic Area: Chronic diseases with high unmet need and long-term safety requirements
- Flagship Candidate: Cinainu, offers durable efficacy, high tolerability, and disease-modifying potential
