TIDMPRTC
PureTech Health PLC
04 June 2020
4 June 2020
PureTech Health plc
PureTech Founded Entity Follica Announces Positive Feedback from
FDA as it Prepares to Advance its Lead Programme in Male
Androgenetic Alopecia into Phase 3 Development
Follica plans to initiate its Phase 3 programme this year
PureTech Health plc (LSE: PRTC) ("PureTech"), a clinical-stage
biotherapeutics company dedicated to discovering, developing and
commercialising highly differentiated medicines for devastating
diseases, is pleased to note that its Founded Entity, Follica,
today announced positive feedback from an End of Phase 2 meeting
with the US Food and Drug Administration (FDA) for its lead
programme to treat male androgenetic alopecia. The company plans to
advance the programme into Phase 3 development this year following
the successful safety and efficacy optimisation study announced in
December 2019.
Bharatt Chowrira, JD, PhD, president and chief of business and
strategy at PureTech, said: "This positive feedback from FDA
enables Follica to move forward with its pivotal trial this year.
Current treatments for the progressive hair loss caused by
androgenetic alopecia are inadequate, and we are pleased with
Follica's progress towards Phase 3 development, bringing us another
step closer to a potential new treatment for the millions of people
seeking safe, effective, non-surgical treatments to grow new
hair."
The full text of the announcement from Follica is as
follows:
Follica Announces Positive Feedback from End of Phase 2 Meeting
with FDA for its Lead Programme to Treat Male Androgenetic
Alopecia
Company plans to initiate its Phase 3 programme this year
BOSTON, June 4, 2020 -- Follica, Inc. ("Follica"), a
biotechnology company developing a regenerative platform designed
to treat androgenetic alopecia, epithelial ageing and other related
conditions, today announced positive feedback from a meeting with
the US Food and Drug Administration (FDA) as the company prepares
to advance its lead programme into Phase 3 development following a
successful safety and efficacy optimisation study for the treatment
of hair loss in male androgenetic alopecia announced in December
2019.
Follica plans to launch its Phase 3 programme this year.
Overall, approximately 280 patients will be enroled, with efficacy
assessed against two co-primary endpoints: visible (non-vellus)
hair count and patient-reported outcomes on a pre-established
scale. The randomised, controlled, double-blinded studies will be
conducted in multiple centers across the US. A maximal use study to
further understand the pharmacokinetics of the treatment will be
conducted in parallel. The trial design is consistent with feedback
from the FDA during the End of Phase 2 meeting.
"In the US alone, 47 million men are affected by progressive
hair loss caused by androgenetic alopecia, a condition that is
largely unresolved today, leaving many dissatisfied with the
current available treatments and looking for a new alternative. Our
recent safety and optimisation study points to a new level of
effect, enabled by our proprietary approach, which stimulates the
growth of new follicles and new hair," said Jason Bhardwaj, chief
executive officer of Follica. "We're grateful to the FDA for their
guidance as we prepare for our pivotal programme, and we look
forward to advancing the development of our treatment regimen,
which has demonstrated strong potential to address the current need
for those who seek treatment for androgenetic alopecia."
Follica's approach is based on generating an "embryonic window"
in adult scalp cells via a series of short office-based treatments
with its proprietary Hair Follicle Neogenesis (HFN) device. The
scalp treatments, 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 growing and thickening new
hair follicles and hair on the scalp.
Follica reported topline results from its safety and
optimisation study in December 2019. That trial was designed to
select the optimal treatment regimen using Follica's proprietary
HFN 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 trial population
and a substantially improved outcome 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 established
statistical significance (p = 0.005).
In addition to the safety and optimisation study, Follica has
validated its approach in prior clinical studies using prototype
HFN devices with different treatment parameters and therapeutic
compounds. Follica's translational work builds on research by
George Cotsarelis, MD, who isolated and characterised the
expression pattern of stem cells from a critical region of the
follicle. An expert in epithelial stem cell biology, Dr Cotsarelis
is 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 ageing
and other related conditions. Founded by PureTech (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 a safety and efficacy optimisation
study in 2019, and its Phase 3 programme in male androgenetic
alopecia is expected to begin in 2020. Follica's technology is
based on work originating from the University of Pennsylvania that
has been further developed by Follica's internal programme.
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 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 Founded Entities,
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, 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
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forward-looking statement speaks only as at the date of this press
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neither the company nor any other party intends to update or revise
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Contact:
Investors EU media US media
Allison Mead Talbot Ben Atwell, Rob Winder Stephanie Simon
+1 617 651 3156 +44 (0) 20 3727 1000 +1 617 581 9333
amt@puretechhealth.com ben.atwell@FTIconsulting.com stephanie@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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