FOLLICA (Abrasion Induced Neogenesis)

(RAIN)

Immune System

TRIAL PHASE
AFFILIATEFOCUSPRTC
OWNERSHIP
PRECLINICALPHASE 1PHASE 2PHASE 3/
PIVOTAL
FILINGFDA CLEARED
Follica
Regenerative Biology Platform for Androgenetic Alopecia
77.9%

Immune System

Follica
Regenerative Biology Platform for Androgenetic Alopecia
77.9%
2
Enabling follicle neogenesis and skin rejuvenation through immune response to wounding

Founded by PureTech Health, Follica’s 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 and other aesthetic-related indications. Follica’s technology is the first, to PureTech’s knowledge, designed to create new follicles and hair through disruption of the skin, followed by treatment to enhance the effect. Follica completed three human clinical studies of patients with androgenetic alopecia to demonstrate hair growth and new hair follicle formation and has been optimizing its device and conducting tests in androgenetic alopecia and other aesthetic indications. 

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 are eligible for treatment in the U.S. alone.
    • Only two drugs, both with limited regrowth efficacy, are currently approved for the treatment of androgenetic alopecia. The most effective current approach for the treatment of hair loss is hair transplant surgery, comprising a range of invasive procedures.
    • As a result, Follica believes that there is significant unmet need for safe, effective, non-surgical treatments which grow new hair.
    • Follica’s regenerative biology platform has applications beyond hair growth to other aging-related conditions and wound healing.
  • Our Approach to Solving the Problem
    • Follica’s approach is based on generating an “embryonic window” in adults via a series of micro skin abrasions, creating new hair follicles from epithelial stem cells, and enhancing the effects through the application of specific compounds.
  • Intellectual Property
    • Follica’s regenerative biology program has broad worldwide intellectual property coverage, including ninety-two (92) patent applications, including thirty-three (33) issued patents, in ten (10) families of patent filings, which are company-owned or exclusively licensed.
    • The intellectual property covers composition of matter and methods of treatment including combination therapies employing disruption approaches and active agents, as well as devices to promote hair follicle regeneration.
  • Team
    • Follica is led by Jason Bhardwaj (previously Bain & Company) and team members Jonathan Bissett (previously NeoSync) and David Chastain (previously Cambridge Consultants and Continuum).
    • Key advisors include Dr. R Rox Anderson (Director of MGH Wellman Labs and Inventor of CoolSculpting by Zeltiq), Dr. George Cotsarelis (University of Pennsylvania Medical School and Founder of Kythera), and Dr. Ken Washenik (Bosley Medical Group and previously Aderans Research Institute).
  • Milestones Achieved
    • Follica 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). Follica is 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’s pivotal study in androgenetic alopecia is expected to begin in 2019 following the completion of an ongoing optimization study.

Follica has preclinical data which show the potential for next-generation proprietary compounds to further enhance the effect of new hair follicle formation. Follica completed its 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 preclinical testing are also ongoing towards the prioritization and development of next-generation, proprietary compounds based on Follica’s intellectual property. Follica’s pivotal study is expected to commence following the completion of the optimization study.


Skin disruption to create new hair follicle