Follica Announces Progression to Pivotal Study Following Positive Interim Data in Male Androgenetic Alopecia

BOSTON--(BUSINESS WIRE)-- Follica, Inc. (“Follica”), a clinical-stage biotech developing a regenerative platform for hair growth, today announced positive interim data from an ongoing safety and optimization study to treat hair loss in male androgenetic alopecia. In addition to being well tolerated and informing key treatment parameters, analysis of 20 male study participants with androgenetic alopecia showed that Follica’s approach achieved a visible and statistically significant improvement in non-vellus (visible) hair count after three months of treatment, compared to baseline. Additionally, blinded head-to-head bench testing of the proprietary Follica device has shown significant therapeutic advantages in scalp treatment versus commercially available skin disruption devices. A pivotal study is expected to initiate at the end of 2019 subject to continued safety and efficacy in the optimization study.

Follica’s platform is designed to induce an “embryonic window” in adult skin via a proprietary form of micro-abrasion that initiates hair follicle neogenesis, the formation of new hair follicles from epithelial (skin) stem cells. This process of hair follicle neogenesis is enhanced through the application of a topical compound as part of the treatment regimen. In addition to the ongoing safety and optimization study, Follica has proof-of-concept data from prior clinical studies using prototype devices with different treatment parameters and therapeutic compounds. Follica’s translational work builds on an important basic discovery by George Cotsarelis, MD, Chair of the Department of Dermatology at the University of Pennsylvania, and a co-founder of Follica.

“Follica’s pioneering work in new hair formation has the potential to address a tremendous need,” said Ken Washenik, MD, PhD, president of Bosley Medical Group, clinical faculty of Dermatology at NYU school of medicine, and senior medical advisor to Follica. “The unique mechanism of action has been studied extensively and is truly differentiated from existing treatment options. The results I’ve reviewed in the interim analysis are exciting and very strong, and I look forward to the initiation of the pivotal study later this year.”

“Some of my past life was spent trying to stop hair from growing, but I’m equally enthusiastic to have been involved in helping advance and optimize George’s key discovery that shows promise for creating new hair,” said R. Rox Anderson, MD, PhD, professor of dermatology at Harvard Medical School, director of the Massachusetts General Hospital Laser Center, and scientific advisor to Follica, who conceived and developed many of the non-scarring treatments now widely used in medical and aesthetic care. These include laser treatments for birthmarks, microvascular and pigmented lesions, tattoo and permanent hair removal, as well as cryolipolysis (Coolsculpting®).

“The biology of wounding in humans is very complex, and our ability to translate its effects into new hair growth is sensitive to a range of treatment factors,” said Jason Bhardwaj, chief executive officer of Follica. “From years of clinical testing, we have optimized the dosing, frequency, and several other important parameters and translated these learnings into a unique and proprietary treatment. Based on this interim analysis and the results of three previously conducted studies, we are excited to move forward into a pivotal study at the end of 2019.”

The safety and optimization study is an endpoint-blinded, randomized, controlled study designed to evaluate Follica’s proprietary skin disruption device in men with androgenetic alopecia and to establish therapeutic parameters, including the optimal duration and frequency of treatment. The study will continue to enroll up to 60 men, ages 18-40, with moderate grades of androgenetic alopecia (Hamilton Norwood III-IV).

About Follica
Follica is a clinical-stage biotech developing a regenerative platform for hair growth. Founded by PureTech Health (LSE: PRTC), a co-inventor of the current platform, and a group of world-renowned experts in hair follicle biology and regenerative medicine, Follica’s device platform has been shown to stimulate the development of new hair follicles and hair in three previously conducted clinical studies. The company’s proprietary device is designed to induce an embryonic window via a device with optimized parameters to create micro-abrasions and initiate hair follicle neogenesis, the formation of new hair follicles from epithelial (skin) stem cells. This process is enhanced through the application of a topical compound. Follica is conducting an ongoing optimization trial, with a pivotal study in androgenetic alopecia expected to begin at the end of Q4 2019. Follica’s technology and strong IP is based on work exclusively licensed from the University of Pennsylvania that has been further enhanced and protected by Follica’s internal development work.

Forward Looking Statement
This press release contains statements that are or may be forward-looking statements, including statements that relate to the company’s future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

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