Follica Announces Progression to Pivotal Study Following Positive Interim Data in Male Androgenetic Alopecia
13 June 2019 - 4:00PM
Business Wire
Pivotal study expected to begin in late
2019
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 FollicaFollica 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 StatementThis 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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version on businesswire.com: https://www.businesswire.com/news/home/20190612005883/en/
InvestorsAllison Mead Talbot+1 617 651
3156amt@puretechhealth.comUS mediaTom Donovan+1 857 559
3397tom@tenbridgecommunications.com
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