Leading experts in the field will advise on
clinical development of PureTech’s lead, wholly-owned product
candidate, LYT-100, in idiopathic pulmonary fibrosis and other
progressive fibrosing interstitial lung diseases
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the
“Company”), a clinical-stage biotherapeutics company dedicated to
discovering, developing and commercializing highly differentiated
medicines for devastating diseases, today announced the formation
of its Clinical Advisory Board for idiopathic pulmonary fibrosis
(IPF) and other progressive fibrosing interstitial lung diseases
(PF-ILDs). Comprised of physicians and researchers with deep
expertise in the clinical development of novel therapies in
PF-ILDs, the advisory group will work closely with PureTech as it
advances LYT-100 (deupirfenidone).
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PureTech today announced the formation of
its Clinical Advisory Board comprised of leading experts in the
development of novel therapies for IPF and related lung disease.
The advisory group will work closely with PureTech as it advances
LYT-100 (deupirfenidone). (Graphic: Business Wire)
“We are proud to have assembled some of the world’s leading
experts in fibrosing lung diseases. These dedicated individuals
have pioneered the research and development of the current
standards of care for the treatment of fibrosing lung diseases, and
they share our commitment to bringing novel therapeutics to these
patients with significant medical needs,” said Daphne Zohar,
Founder and Chief Executive Officer of PureTech. “Progressive
fibrosing interstitial lung diseases impact approximately 200,000
patients in the United States alone, yet currently available
treatment options have significant tolerability issues and
dose-limiting toxicities. We believe LYT-100 has the potential to
treat a wide array of these conditions, including IPF, and the
advisory board’s guidance will help us advance LYT-100.”
Members of the Clinical Advisory Board include:
- Bill Bradford, M.D., Ph.D., is a biopharma advisor with
broad expertise in drug development. Dr. Bradford, formerly Senior
Vice President, Clinical Development at InterMune, successfully
developed pirfenidone for the treatment of IPF.
- Vincent Cottin, M.D., is a Professor of Respiratory
Medicine at Université Claude Bernard Lyon and Coordinator of the
National Coordinating Reference Center for Rare Pulmonary Diseases
at Louis Pradel Hospital, Hospices Civils de Lyon, Lyon, France.
Dr. Cottin is a pioneer in the clinical care and research of
patients with rare and orphan lung diseases and is currently the
Section Editor of the European Respiratory Journal for interstitial
lung diseases (ILDs).
- Kevin Flaherty, M.D., is a Professor at the University
of Michigan specializing in IPF and other ILDs. Dr. Flaherty is the
lead author of a study published in the New England Journal of
Medicine titled, “Nintedanib in Progressive Fibrosing Interstitial
Lung Diseases,” which was a Phase 3 trial of nintedanib in patients
with fibrosing lung disease.
- Toby Maher, M.D., Ph.D., is a Professor of Clinical
Medicine and Director of Interstitial Lung Disease at Keck School
of Medicine of the University of Southern California. Dr. Maher is
the principal investigator of PureTech’s LYT-100 study in Long
COVID and was the lead author of research published in Lancet
Respiratory Medicine discussing results of the Phase 2 trial of
pirfenidone in patients with unclassifiable PF-ILDs.
- Paul Noble, M.D., is Chair of the Department of Medicine
at Cedars-Sinai Medical Center and a noted researcher in lung
inflammation and fibrosis. Dr. Noble is the lead author of a study
in The Lancet analyzing the results of two late-stage studies
evaluating the effect of pirfenidone on lung deterioration in
patients with IPF.
- Marlies Wijsenbeek, M.D., Ph.D., is a pulmonary
physician at the Erasmus Medical Center in Rotterdam, Netherlands,
and Chair of the center’s multidisciplinary programs in ILDs. Dr.
Wijsenbeek is the lead investigator on an international
observational study to identify disease progression and evaluate
the efficacy of home monitoring in patients with newly diagnosed
fibrosing ILDs.
IPF is a fatal disease characterized by a progressive and
irreversible decline in lung function. There are only two
FDA-approved agents indicated to treat IPF: pirfenidone (Esbriet®)
and nintedanib (Ofev®). While clinically effective, pirfenidone is
associated with significant tolerability complications that hamper
treatment compliance in approximately 50 percent of patients who
begin therapy, resulting in sub-optimal disease management1.
LYT-100 is a selectively deuterated form of pirfenidone that has
been shown to maintain the anti-inflammatory and anti-fibrotic
properties of the parent compound while demonstrating a favorable
pharmacokinetic (PK) profile. Accordingly, PureTech is developing
LYT-100 to offer a differentiated safety profile compared to
current standard of care drugs, which may support improved patient
compliance while retaining or exceeding efficacy. PureTech is
currently planning registration-enabling studies with LYT-100 in
IPF and related PF-ILDs.
"IPF causes irreversible scarring of the lungs, which worsens
over time and makes it difficult for patients to breathe. Despite
the currently available treatments, the prognosis for IPF remains
poor, and there is a substantial need for therapeutics that can
make a meaningful difference for patients,” said Dr. Maher.
“LYT-100 has a desirable tolerability and PK profile and has shown
promising potential for this underserved patient population. I look
forward to helping to advance LYT-100 as a member of PureTech’s
Clinical Advisory Board.”
In addition to developing LYT-100 for the treatment of PF-ILDs,
PureTech has commenced two clinical trials evaluating this
therapeutic candidate in other indications. These include: 1) a
global Phase 2 trial in adults with Long COVID respiratory
complications and related sequelae and 2) a Phase 2a
proof-of-concept study in patients with breast-cancer related,
upper limb secondary lymphedema.
About LYT-100
LYT-100 is PureTech’s most advanced wholly-owned therapeutic
candidate. A deuterated form of pirfenidone, an approved
anti-inflammatory and anti-fibrotic drug, LYT-100 is being advanced
for the potential treatment of conditions involving inflammation
and fibrosis, including lung disease (e.g., IPF and potentially
other PF-ILDs and Long COVID respiratory complications and related
sequelae), and disorders of lymphatic flow, such as lymphedema.
PureTech completed a Phase 1 multiple ascending dose and food
effect study evaluating LYT-100 in healthy volunteers and found it
to be well-tolerated at all doses tested. PureTech is evaluating
LYT-100 in a Phase 2 trial as a potential treatment for Long COVID
respiratory complications and related sequelae as well as in a
Phase 2a proof-of-concept study in patients with breast
cancer-related, upper limb secondary lymphedema. PureTech is also
advancing LYT-100 for the treatment of IPF and potentially other
PF-ILDs and is planning registration-enabling studies.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercializing highly
differentiated medicines for devastating diseases, including
inflammatory, fibrotic and immunological conditions, intractable
cancers, lymphatic and gastrointestinal diseases and neurological
and neuropsychological disorders, 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 26 therapeutics and therapeutic
candidates, including two that have received FDA clearance and
European marketing authorization, as of the date of PureTech’s most
recently filed Annual Report on Form 20-F. All of the underlying
programs and platforms that resulted in this pipeline of
therapeutic 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 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, our expectations regarding the potential therapeutic benefits
of LYT-100 including its comparative advantages over and potential
to replace the current standard of care for IPF, our expectations
regarding the development, design and advancement of LYT-100, our
expectations regarding the formation of our new Clinical Advisory
Board 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.
Esbriet® is a registered trademark of Genentech, Inc. and Ofev®
is a registered trademark of Boehringer Ingelheim International
GmbH. Neither is owned by or affiliated with PureTech Health.
1 Cottin, V., Koschel, D., Günther, et al. (2018). Long-term
safety of pirfenidone: Results of the prospective, observational
PASSPORT study. ERJ Open Research, 4(4), 00084-2018.
doi:10.1183/23120541.00084-2018
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Investors Allison Mead Talbot +1 617 651 3156
amt@puretechhealth.com U.S. media Stephanie Simon +1 617 581
9333 stephanie@tenbridgecommunications.com
PureTech Health (NASDAQ:PRTC)
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