TIDMPRTC
PureTech Health PLC
19 December 2019
19 December 2019
PureTech Health plc
PureTech Health Affiliate Follica Announces Positive Topline
Data from Clinical Study in Male Androgenetic Alopecia
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
PureTech Health plc (LSE: PRTC) ("PureTech") is pleased to note
that its affiliate Follica today announced topline results from its
safety and efficacy optimisation 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 products(1) established statistical
significance (p = 0.005). The initiation of a Phase 3 registration
study is expected in the first half of 2020.
Joseph Bolen, PhD, chief scientific officer at PureTech, said:
"Currently, there are only two approved drugs on the market for the
treatment of androgenetic alopecia, both of which have only
demonstrated a 12% increase of non-vellus hair count over baseline.
There remains a significant need for safe, effective, non-surgical
treatments to grow new hair, and we believe the Follica data
demonstrate strong promise as a potential new standard of care for
the millions of people hoping to address their androgenetic
alopecia."
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. 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 full text of the announcement from Follica is as
follows:
Follica Announces Positive Topline Data from Clinical Study in
Male Androgenetic Alopecia
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
BOSTON, Dec. 19, 2019 - 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 optimisation 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 products(1) established statistical
significance (p = 0.005). The initiation of a Phase 3 registration
study is expected in the first half of 2020.
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 optimised 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
optimised 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 optimise 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(R)).
The safety and efficacy optimisation study was an
endpoint-blinded, randomised, 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 optimisation 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 alopecia(1) . 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 optimised 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 optimisation 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.
About PureTech Health
PureTech is a clinical stage biotechnology company dedicated to
discovering, developing and commercialising highly differentiated
medicines for devastating diseases, including intractable cancers,
lymphatic and gastrointestinal diseases, central nervous system
disorders, and inflammatory and immunological diseases, among
others. The Company has created a broad and deep pipeline through
the expertise of its experienced research and development team and
its extensive network of scientists, clinicians and industry
leaders. This pipeline, which is being advanced both internally and
through PureTech's affiliates, is comprised of 23 product
candidates and one product that has been cleared by the US Food and
Drug Administration (FDA). All of the underlying programmes and
platforms that resulted in this pipeline of product candidates were
initially identified or discovered and then advanced by the
PureTech team through key validation points based on the Company's
unique insights into the biology of the brain, immune, and gut, or
BIG, systems and the interface between those systems, referred to
as the BIG Axis.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
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forward-looking statements are based on current expectations and
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to, those risks and uncertainties described in the risk factors
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Contact:
Investors EU media US media
Allison Mead Talbot Ben Atwell, Rob Winder Tom Donovan
+1 617 651 3156 +44 (0) 20 3727 1000 +1 857 559 3397
amt@puretechhealth.com ben.atwell@FTIconsulting.com tom@tenbridgecommunications.com
(1) Olsen 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
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END
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