TIDMPRTC
PureTech Health PLC
10 December 2020
10 December 2020
PureTech Health plc
PureTech Initiates Phase 2a trial of LYT-100 (Deupirfenidone) in
Lymphedema
Study will further evaluate safety and tolerability of LYT-100
and explore clinical efficacy endpoints in patients with
breast-cancer related, upper limb secondary lymphedema
Previously announced results from multiple ascending dose and
food effect study in healthy volunteers demonstrated favorable
tolerability and pharmacokinetic proof-of-concept for LYT-100
A separate Phase 2 study evaluating LYT-100 in Long COVID
respiratory complications and related sequelae was recently
initiated
Registration-enabling studies are also being planned for LYT-100
in idiopathic pulmonary fibrosis (IPF)
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, today announced the initiation
of a Phase 2a proof-of-concept study of LYT-100 (deupirfenidone) in
patients with breast cancer-related, upper limb secondary
lymphedema, a chronic and progressive disorder for which there are
no FDA-approved drug therapies . LYT-100 is PureTech's wholly-owned
product candidate that is being advanced for the potential
treatment of conditions involving inflammation and fibrosis and
disorders of lymphatic flow.
LYT-100 is a deuterated, oral small molecule designed to
overcome the challenges associated with pirfenidone, an approved
and marketed anti-inflammatory and anti-fibrotic drug. LYT-100, a
new chemical entity, retains the pharmacology of pirfenidone but
has a differentiated pharmacokinetic (PK) profile, which is
designed to enable improved tolerability, less frequent dosing and
potentially increased efficacy. PureTech recently completed a Phase
1 multiple ascending dose and food effect study of LYT-100 in
healthy volunteers, which demonstrated a favorable tolerability and
PK profile for LYT-100. LYT-100 has also been evaluated in
preclinical lymphedema models, where it halted progression of
lymphedema and reduced swelling volume.
"Lymphedema is a debilitating condition that affects
approximately one million people in the U.S., and it is
particularly prevalent in women recovering from breast cancer . It
can restrict range of motion in the arms, cause significant pain
and lead to disfiguring swelling and recurring infections," said
Babak J. Mehrara, M.D., chief, plastic and reconstructive surgical
service at Memorial Sloan Kettering Cancer Center and an advisor to
PureTech. "There are no approved drugs to address lymphedema and
there's little relief that can be offered to patients other than
compression bandages, exercise and massage. We have a very real
need for a therapeutic that could effectively treat this condition,
which has been overlooked for far too long."
The randomized, placebo-controlled, Phase 2a proof-of-concept
study of LYT-100 is expected to enroll up to 50 patients with
breast cancer-related, upper limb secondary lymphedema. The primary
endpoints for this trial will be safety and tolerability, with
secondary clinical efficacy and biomarker endpoints. The study is
not powered to evaluate statistical significance compared to
placebo, but PureTech expects to use data emerging from the trial
to shape future clinical protocols, including selection of
potential future efficacy study endpoints. Results from this
proof-of-concept study are expected in the fourth quarter of
2021.
"Lymphedema is a condition that has drawn far too little
attention from the healthcare industry. That oversight means there
are, to date, no standardized clinical endpoints for the treatment
of lymphedema," said Michael Chen, Ph.D., head of innovation at
PureTech. "This proof-of-concept study will be extremely valuable
in helping us identify the most compelling clinical endpoints for
future studies."
About Lymphedema
Lymphedema is a chronic condition that afflicts approximately
one million people in the United States and is characterized by
severe swelling in parts of the body, typically the arms or legs,
due to the build-up of lymph fluid and inflammation, fibrosis and
adipose deposition. Secondary lymphedema is the most prevalent form
of lymphedema, and it can develop after surgery, infection or
trauma and is frequently caused by cancer or cancer treatments. A
chronic and progressive disorder, lymphedema can cause loss of
range of motion and function in the affected limb, disfigurement
and pain. Inflammation and fibrosis play important roles in the
pathophysiology of secondary lymphedema. Targeting fibrosis in
addition to inflammation may be a potentially effective way of
ameliorating lymphedema in patients. The current standard of care
for lymphedema is management, primarily by compression and physical
therapy to control swelling. There are no FDA-approved drug
therapies to treat lymphedema.
About LYT-100
LYT-100 is PureTech's most advanced wholly-owned product
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 and disorders of lymphatic flow, including lung
dysfunction conditions (e.g., IPF, unclassifiable interstitial lung
diseases (uILDs), Long COVID respiratory complications and related
sequelae) and lymphedema. PureTech completed a Phase 1 multiple
ascending dose and food effect trial 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 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
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 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 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 in patients with breast cancer-related, upper limb
secondary lymphedema, the expected timing of results from our Phase
2a proof-of-concept trial of LYT-100 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.
Contact:
Investors EU media US media
Allison Mead Talbot Ben Atwell, Rob Winder Adam Silverstein
+1 617 651 3156 +44 (0) 20 3727 1000 +1 917 697 9313
amt@puretechhealth.com ben.atwell@FTIconsulting.com adam@tenbridgecommunications.com
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