Legacy Healthcare Gets PMDA Green Light for Phase 3 Trial of Cinainu in Japan

Legacy Healthcare Gets PMDA Green Light for Phase 3 Trial of Cinainu in Japan

By, Admin 6 August 2025

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

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