Follica Announces Pilot Study for Female Pattern Hair Loss Published in International Journal of Women’s Dermatology
December 09 2020 - 12:42PM
Business Wire
Treatment based on proprietary scalp skin
disruption promoted hair growth
Results of the pilot study are encouraging and
warrant larger studies in women
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.
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Investors Allison Mead Talbot +1 617 651 3156
amt@puretechhealth.com U.S. media Adam Silverstein +1
917-697-9313 adam@tenbridgecommunications.com
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