Abrasion Induced Neogenesis

(RAIN)

Immune System

TRIAL PHASE
MECHANISMINDICATION(S)PRODUCT NAMEPreclinicalPhase 1Phase 2Phase 3
Abrasion Induced Neogenesis
Androgenetic Alopecia, Epithelial Aging
Follica
(RAIN)

Immune System

Abrasion Induced Neogenesis
INDICATION(S):Androgenetic Alopecia, Epithelial Aging
NAME:Follica (RAIN)
STAGE:Phase 2
Regenerative biology platform

Our regenerative biology program is based on seminal findings from the University of Pennsylvania which demonstrated the creation of mammalian skin organs in adult mammals after abrasion. This technology is initially being applied to treat androgenetic alopecia. Our technology is the first, to our knowledge, designed to create new follicles and hair through mild abrasion of the skin, followed by treatment to enhance the effect. We have completed three human clinical studies in people with androgenetic alopecia to demonstrate hair growth and new hair follicle formation. 

  • Patient Need & Market Potential
    • Androgenetic alopecia represents the most common form of hair loss in men and women, with an estimated 65 million people who warrant treatment in the U.S. alone 
    • Only two drugs, both with limited efficacy, are currently approved for the treatment of androgenetic alopecia. The most effective current approach for the treatment of hair loss is hair transplantation, comprising of a range of invasive procedures 
    • As a result, we believe that there is a significant unmet need for safe, effective, non-surgical treatments which grow new hair 
    • Our regenerative biology platform has applications beyond hair growth to other aging related conditions and wound healing
  • Our Approach to Solving the Problem
    • Our regenerative biology platform is based on generating an “embryonic window” in adult mammals via a series of slight injuries, creating new follicles from epithelial stem cells, and enhancing the effects through the application of specific compounds
  • Intellectual Property
    • Our regenerative biology program has broad worldwide intellectual property coverage, including exclusive rights to 38 issued patents and patent applications
    • The intellectual property covers the composition of matter, methods of use and design of disruption approaches and active agents to promote hair follicle regeneration 
  • Team
    • Key advisors include:

      Dr. R. Rox Anderson, a Professor of Dermatology, Harvard Medical School and Adjunct Professor of Health Sciences and Technology at MIT, and Inventor of CoolSculpting by Zeltiq;

      Dr. George Cotsarelis, Chair of Dermatology at University of Pennsylvania Medical School and Founder of Kythera; and

      Dr. Ken Washenik, President and Chief Medical Officer of Bosley Medical Group and Former Chief Executive Officer of Aderans Research Institute

    • The program is led by Jason Bhardwaj and team members Jonathan Bissett and David Chastain
  • Milestones Achieved
    • The product concept originated from groundbreaking science demonstrating new mammalian organ skin organ formation in adult mice following abrasion. The results were published in the prestigious journal, Nature Magazine 
    • We conducted three clinical studies of patients with androgenetic alopecia, which demonstrated hair follicle neogenesis via biopsy following skin disruption and hair growth through target area hair count. One of these studies demonstrated that skin disruption alone was safe and generates not only new hair follicles and but also terminal (visible, thick) hairs. We are further developing and testing compounds that enhance these effects
  • Expected Milestones and Timing
    • Our regenerative biology program is currently progressing into a pre-pivotal pilot optimization study expected to start in early 2018, with a pivotal trial expected to begin in the first half of 2018

We have preclinical and clinical data, which together with research from the University of Pennsylvania, serve as the foundational observations on which the technology is based. We are progressing our proprietary regenerative biology platform technology, and expect to initiate a pivotal trial in the first half of 2018.


Skin disruption to create new hair follicle


Presentation