Treatment with Follica’s proprietary Hair
Follicle Neogenesis stimulation product promoted hair growth
Results of the pilot study are encouraging and
warrant larger studies in women
PureTech Health plc (LSE: PRTC, Nasdaq: PRTC) (“PureTech” or the
“Company”), a clinical-stage biotherapeutics company dedicated to
discovering, developing and commercializing highly differentiated
medicines for devastating diseases, is pleased to note that its
Founded Entity, Follica, today announced the publication of a pilot
study evaluating scalp skin disruption to promote hair growth in
female pattern hair loss (FPHL) in International Journal of Women’s
Dermatology. The treatment promoted hair growth over a four-month
course of treatment.
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An MGH pilot study evaluating scalp skin
disruption using Follica’s proprietary Hair Follicle Neogenesis
stimulation product was published in International Journal of
Women’s Dermatology, demonstrating the treatment promoted hair
growth in female pattern hair loss. The study endpoints included
photographs, patient-reported improvement and physician-documented
Sinclair score.
The pilot study, led by Maryanne M. Senna, M.D., an assistant
professor of dermatology at Harvard Medical School, enrolled 11
women with mild to moderate FPHL who had been on stable existing
treatments for six or more months. Patients underwent six
treatments with the Follica proprietary Hair Follicle Neogenesis
(HFN) device and application of a topical on-market drug on
non-treatment days. The scalp treatments with the HFN device, which
last just a few minutes, stimulate stem cells and enable the growth
of new hair follicles. A topical drug is then applied to enhance
efficacy by thickening new hair follicles and hair on the scalp.
The study endpoints included photographs, physician-documented
Sinclair score and patient-reported improvement.
The full text of the announcement from Follica is as
follows:
Follica Announces Pilot Study for Female
Pattern Hair Loss Published in International Journal of Women’s
Dermatology
Treatment based on proprietary scalp skin
disruption promoted hair growth
Results of the pilot study are encouraging and
warrant larger studies in women
BOSTON, December 9, 2020 – Follica, Inc. (“Follica”), a
biotechnology company developing a regenerative platform designed
to treat androgenetic alopecia, epithelial aging and other related
conditions, today announced the publication of a pilot study
evaluating scalp skin disruption to promote hair growth in female
pattern hair loss (FPHL) in International Journal of Women’s
Dermatology. The treatment promoted hair growth over a four-month
course of treatment.
The pilot study, led by Maryanne M. Senna, M.D., an assistant
professor of dermatology at Harvard Medical School, enrolled 11
women with mild to moderate FPHL who had been on stable existing
treatments for six or more months. Patients underwent six
treatments with the Follica proprietary Hair Follicle Neogenesis
(HFN) device and application of a topical on-market drug on
non-treatment days. The scalp treatments with the HFN device, which
last just a few minutes, stimulate stem cells and enable the growth
of new hair follicles. A topical drug is then applied to enhance
efficacy by thickening new hair follicles and hair on the scalp.
The study endpoints included photographs, physician-documented
Sinclair score and patient-reported improvement.
At the end of the study, 10 out of the 11 patients reported
perceived improvement in hair growth and all 11 improved on their
physician-graded Sinclair scores. Average improvement on the
Sinclair scale, which runs from stage 1 to stage 5, was one full
stage. The adverse events reported were mild and self-resolving,
and all women completed the course of treatment. Although the
sample size was limited, the study’s authors called the results
encouraging and called for larger studies.
“Around 40 percent of women show signs of hair loss by age 50,
and for many this starts at an earlier age. Although many women
struggle with this condition, there are very few effective
treatment options available, and all too often, investigational
therapies are tested primarily in men,” said Dr. Senna, who directs
the hair loss clinic at Massachusetts General Hospital. “This pilot
study was small but encouraging, as almost all of the patients
reported meaningful improvements. This was especially welcome since
many of these women had tried other treatments without success.
There’s a significant treatment gap for women in this field, and
it’s terrific to see new approaches with the potential to close
that gap. I look forward to additional research on how the Follica
device could address female pattern hair loss.”
“This study demonstrates the potential of our regenerative
approach at Follica, which is intended to create an embryonic
window in adult skin, essentially allowing new follicles and new
hair to form from epithelial stem cells. It confirms that, while
our treatment may not yet be optimized for females, the mechanism
of action has the potential to address both male and female
androgenetic alopecia and makes clear that the device works well
with longer hair as well as shorter hair,” said Jason Bhardwaj, CEO
of Follica. “We’re excited to continue advancing our technology as
we work to bring effective new treatment options to both men and
women.”
Follica plans to advance its lead program into Phase 3
development in 2021, following a successful safety and efficacy
optimization study for the treatment of hair loss in male
androgenetic alopecia and a successful meeting with the Food and
Drug Administration at the conclusion of the Phase 2 study. The
optimization study in male androgenetic alopecia 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 percent improvement of non-vellus
(visible) hair count after three months of treatment compared to
baseline (p < 0.001, n = 19).
About Follica Follica is a biotechnology company
developing a regenerative platform designed to treat androgenetic
alopecia, epithelial aging and other related conditions. Founded by
PureTech (LSE: PRTC, Nasdaq: 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 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 a safety and efficacy optimization
study in 2019, and its Phase 3 registration program in male
androgenetic alopecia is expected to begin in 2021. 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
biotherapeutics company dedicated to discovering, developing and
commercializing 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
Founded Entities, is comprised of 24 products and product
candidates, including two that have received U.S. Food and Drug
Administration (FDA) clearance and European marketing
authorization. All of the underlying programs 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.
Cautionary Note Regarding Forward-Looking Statements This
press release contains statements that are or may be
forward-looking statements, including statements that relate to our
product candidates and approach towards addressing major diseases,
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, our
expectations regarding the potential therapeutic benefits of the
Follica proprietary Hair Follicle Neogenesis (HFN) Device,
expectations regarding the timing and results from Follica’s
planned Phase 3 study of its lead program and 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/20201209005233/en/
Investors Allison Mead Talbot +1 617 651 3156
amt@puretechhealth.com
EU media Ben Atwell, Rob Winder +44 (0) 20 3727 1000
ben.atwell@FTIconsulting.com
U.S. media Adam Silverstein +1 917 697 9313
adam@tenbridgecommunications.com
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