Demonstrated
44% improvement over baseline of visible (non-vellus) hair count, a
well-established hair growth measure (p value <
0.001)
Study met
primary endpoint and identified optimal frequency and number of
treatments with Follica’s proprietary device in combination with a
topical drug after three months of treatment
Phase 3
registration study initiation expected in first half of
2020
Follica, Inc. (“Follica”), a biotechnology company developing a
regenerative platform designed to treat androgenetic alopecia,
epithelial aging and other medical indications, today announced
topline results from its safety and efficacy optimization study to
treat hair loss in male androgenetic alopecia. The study was
designed to select the optimal treatment regimen using Follica’s
proprietary device in combination with a topical drug and
successfully met its primary endpoint. The selected treatment
regimen demonstrated a statistically significant 44% improvement of
visible (non-vellus) hair count after three months of treatment
compared to baseline (p < 0.001, n = 19). Across all three
treatment arms, the overall improvement of visible (non-vellus)
hair count after three months of treatment was 29% compared to
baseline (p < 0.001, n = 48), reflecting a clinical benefit
across the entire study population and a substantially improved
outcome seen with the optimal treatment regimen. Additionally, a
prespecified analysis comparing the 44% change in visible
(non-vellus) hair count to a 12% historical benchmark set by
approved pharmaceutical products1 established statistical
significance (p = 0.005). The initiation of a Phase 3 registration
study is expected in the first half of 2020.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20191218005795/en/
What is androgenetic alopecia? (Graphic:
Business Wire)
Follica’s proprietary in-office treatment regimen combines
targeted scalp disruption using the Follica Hair Follicle
Neogenesis (HFN) device, with a topical on-market drug to create
and grow new hair follicles. Based on clinical testing over several
years, Follica has optimized a range of important parameters to
enable the therapeutic effect. Specifically, Follica’s proprietary
HFN device is designed to create new hair follicles and hair on the
scalp for the treatment of androgenetic alopecia. In blinded
head-to-head bench testing, the Follica HFN device significantly
outperforms available skin disruption devices on key treatment
parameters important for hair follicle neogenesis. The topline
results from this clinical study, together with three previously
conducted clinical trials, provide important validation for
Follica’s proprietary approach for the treatment of androgenetic
alopecia.
“The topline results of this study represent an exciting
potential new treatment to address a persisting challenge in our
field: identifying a successful approach to growing new hair in
patients who have lost hair,” said Ken Washenik, MD, PhD, president
and medical director of Bosley Medical Group, clinical faculty of
dermatology at NYU School of Medicine and senior medical advisor to
Follica. “We believe Follica is the first to bring forward an
approach to grow new hair that is now supported by strong human
efficacy data. The compelling data generated by the company thus
far indicate that Follica’s approach could be a promising new
option for the approximately 90 million people who are eligible for
the treatment of androgenetic alopecia in the United States
alone.”
The study involved a less than five-minute in-office
experimental scalp procedure using the proprietary Follica HFN
device designed to stimulate hair follicle growth and evaluated the
optimal frequency and number of treatments across three arms.
Follica’s approach is based on generating an “embryonic window” in
adults via a series of skin disruptions, stimulating stem cells and
causing new hair follicles to grow. This process of hair follicle
neogenesis involves minimal daily interruption and is enhanced
through the application of a topical compound as part of the
treatment regimen following HFN.
“We are very pleased with the results of this study and are
especially excited to demonstrate the strength of Follica’s
proprietary device and treatment regimen,” said Jason Bhardwaj,
chief executive officer of Follica. “Our data show that clinical
results differ significantly based on the approach to disrupting
the skin and confirm Follica’s proprietary treatment paradigm is
optimized for new hair growth. We look forward to initiating the
pivotal trial.”
“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 Cotsarelis’ 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 safety and efficacy optimization study was an
endpoint-blinded, randomized, controlled study designed to
establish therapeutic parameters for Follica’s proprietary device
in combination with a topical drug. The study consisted of 48 men
aged 18-40 who had moderate grades of androgenetic alopecia
(Hamilton Norwood III-IV). The optimal frequency and number of
treatments was studied across three treatment arms. The regimen was
well tolerated across all treatment arms with no reported serious
adverse events. No adverse events were related to device treatment.
A single non-severe event (headache) was determined to be related
to use of the drug and is in line with minor side effects seen from
treatment with the approved drug alone.
In addition to the safety and efficacy 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.
About Androgenetic Alopecia Androgenetic alopecia
represents the most common form of hair loss in men and women, with
an estimated 90 million people who are eligible for treatment in
the United States alone. Only two drugs, both of which have
demonstrated a 12% increase of non-vellus hair count over baseline
for their primary endpoints, are currently approved for the
treatment of androgenetic alopecia1. The most effective current
approach for the treatment of hair loss is hair transplant surgery,
comprising a range of invasive, expensive procedures for a subset
of patients who have enough donor hair to be eligible. As a result,
there remains a significant need for safe, effective, non-surgical
treatments to grow new hair.
About Follica Follica is a biotechnology company
developing a regenerative platform designed to treat androgenetic
alopecia, epithelial aging and other medical indications. 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 experimental treatment
platform has been shown to stimulate the development of new hair
follicles and hair in three previously conducted clinical studies.
The company’s proprietary treatment is designed to induce an
embryonic window via a device with optimized parameters to 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 completed an
optimization trial and a Phase 3 registration study in androgenetic
alopecia is expected to begin in the first half of 2020. Follica’s
technology is based on work originating from the University of
Pennsylvania that has been further developed by Follica’s internal
program. Follica’s extensive IP portfolio includes IP exclusively
licensed from the University of Pennsylvania as well as
Follica-owned IP.
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.
1Olsen EA et al, J Am Acad Dermatol. 2002 Sep;47(3):377-85 Olsen
EA et al, J Am Acad Dermatol. 2007 Nov;57(5):767-74. Epub 2007 Aug
29 Price VH et al, J Am Acad Dermatol. 2002 Apr;46(4):517-23
Kaufman et al, J Am Acad Dermatol. 1998 Oct; 39(4):578-589
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191218005795/en/
Investors Allison Mead Talbot +1 617 651 3156
amt@puretechhealth.com
US media Tom Donovan +1 857 559 3397
tom@tenbridgecommunications.com
Puretech Health (LSE:PRTC)
Gráfica de Acción Histórica
De Mar 2024 a Abr 2024
Puretech Health (LSE:PRTC)
Gráfica de Acción Histórica
De Abr 2023 a Abr 2024