FOLLICA (Abrasion Induced Neogenesis)

(RAIN)

Immune System

TRIAL PHASE
AFFILIATEFOCUSPRTC
OWNERSHIP
PRECLINICALPHASE 1PHASE 2PHASE 3/
PIVOTAL
FILING
Follica
Regenerative Biology Platform for Androgenetic Alopecia
55.6%

Immune System

Follica
Regenerative Biology Platform for Androgenetic Alopecia
55.6%
2
Regenerative biology platform

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

We have preclinical data which show the potential for next-generation proprietary compounds to further enhance the effect of new hair follicle formation. We completed our clinical-stage development of a next-generation device and drug combination product for androgenetic alopecia, which is currently in an optimization study. Further phases of pre-clinical testing are also ongoing towards the prioritization and development of next-generation, proprietary compounds based on our intellectual property. Our RAIN pivotal study is expected to commence following the completion of the optimization study.

  • 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 a range of invasive procedures.
    • As a result, we believe that there is 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 approach is based on generating an “embryonic window” in adults via a series of micro 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
    • Follica is led by Jason Bhardwaj and team members Jonathan Bissett and David Chastain.
    • Key advisors include Dr. R. Rox Anderson (MIT and Inventor of CoolSculpting by Zeltiq). Dr. George Cotsarelis (University of Pennsylvania Medical School and Founder of Kythera), Dr. Ken Washenik (Bosley Medical Group and formerly Aderans Research Institute).
  • Milestones Achieved
    • 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 but also terminal (visible, thick hairs). We are further developing and testing compounds that enhance these effects.
    • The product concept originated from ground-breaking science demonstrating new mammalian skin formation in adult mice following abrasion. The results were published in the top tier medical science journal, Nature.
  • Expected Milestones and Timing
    • Follica expects to initiate the pivotal study in androgenetic alopecia following completion of an ongoing optimization study in the first half of 2019. 

We have preclinical data which show the potential for next-generation proprietary compounds to further enhance the effect of new hair follicle formation. We completed our clinical-stage development of a next-generation device and drug combination product for androgenetic alopecia, which is currently in an optimization study. Further phases of pre-clinical testing are also ongoing towards the prioritization and development of next-generation, proprietary compounds based on our intellectual property. Our RAIN pivotal study is expected to commence following the completion of the optimization study.


Skin disruption to create new hair follicle