TIDMPRTC
PureTech Health PLC
03 March 2020
3 March 2020
PureTech Health plc
PureTech Announces First Participant Dosed in Clinical Trial of
Wholly-Owned Lymphoedema Candidate LYT-100
Multiple ascending dose and food effect study will be a
follow-up to a previously conducted single ascending dose clinical
trial of LYT-100
Proof-of-concept study in patients with breast cancer-related
lymphoedema also expected to begin this year
PureTech Health plc (LSE: PRTC) ("PureTech," or the "Company"),
a clinical stage biotherapeutics company dedicated to discovering,
developing and commercialising highly differentiated medicines for
devastating diseases, today announced that the first participant
has been dosed in a clinical study of LYT-100, PureTech's
wholly-owned product candidate for the potential treatment of
lymphoedema and other fibrotic conditions. There are currently no
FDA-approved drugs to treat lymphoedema, which is a painful,
progressive, and chronic condition that affects approximately one
million individuals in the US alone, including about 500,000 breast
cancer survivors.
The Phase 1, multiple ascending dose and food effect study is
designed to evaluate the safety, tolerability and pharmacokinetic
(PK) profile of LYT-100 in healthy participants. This is a
follow-up to the single ascending dose clinical trial of LYT-100 in
healthy individuals that was conducted by Auspex. Results from the
multiple ascending dose study are expected this year and will
enable the initiation of a proof-of-concept study in people with
breast cancer-related, upper limb secondary lymphoedema later in
2020.
"Lymphatic diseases cause significant disability and pain, yet
there are few meaningful treatment options, most of which involve
compression and physical therapy to control swelling," said Babak
Mehrara, MD, chief, plastic and reconstructive surgical service,
the Peter G. Cordeiro endowed chair in plastic and reconstructive
surgery at Memorial Sloan Kettering Cancer Center and an advisor to
PureTech. "LYT-100 is designed to address the underlying cause of
lymphoedema by reducing fibrosis and inflammation and restoring
lymphatic function, and I believe it holds tremendous potential as
a therapeutic candidate for the treatment of lymphoedema."
LYT-100 is an oral, small molecule drug candidate known as
deupirfenidone, which has demonstrated preclinical anti-fibrotic
and anti-inflammatory activity. It has previously been studied in
healthy volunteers as part of a Phase 1, single-dose study and was
observed to be well-tolerated with a favourable pharmacokinetic
profile that could support twice daily oral dosing.
LYT-100 is the first clinical programme in PureTech's Wholly
Owned Pipeline, which is focused on harnessing the lymphatic system
and related immunology mechanisms for the treatment of cancer,
immunological, lymphatic and central nervous system (CNS)-related
disorders.
"Our model at PureTech has always been to identify, invent and
advance novel therapeutics. We work with the world's leading
experts in a discovery process that breaks down specific diseases
and comprehensively reviews and empirically tests unpublished
scientific discoveries in a modality agnostic and unbiased way.
This approach has enabled us to rapidly convert findings into
valuable therapeutic product candidates, which historically have
been housed in subsidiaries," said Daphne Zohar, co-founder and
chief executive officer of PureTech. "The advancement of LYT-100 is
another example of executing on our strategy to develop a
therapeutic solution for significant need, though this time the
product candidate will continue to be wholly owned by
PureTech."
About Lymphoedema
Lymphoedema is a chronic condition that afflicts approximately
one million people in the United States and is characterised 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 lymphoedema is the most prevalent
form of lymphoedema, and it can develop after surgery, infection or
trauma and is frequently caused by cancer or cancer treatments. A
chronic and progressive disorder, lymphoedema can cause loss of
range of motion and function in the affected limb, disfigurement
and pain. The standard of care is management, primarily by
compression and physical therapy to control swelling. There are no
FDA-approved drug therapies to treat lymphoedema.
About LYT-100
LYT-100 is one of PureTech's wholly-owned product candidates. It
is an oral, small molecule drug candidate known as deupirfenidone,
which is in development for the potential treatment of lymphoedema
and other lymphatic and fibrotic disorders. LYT-100 has
demonstrated preclinical anti-fibrotic and anti-inflammatory
activity and has shown greater activity when compared to a
functional analogue drug. LYT-100 is currently being evaluated in a
Phase 1 multiple ascending dose and food effect study in healthy
volunteers with subsequent exploration planned in people with
breast cancer-related, upper limb secondary lymphoedema. PureTech
also plans to evaluate the potential application of LYT-100 in
other conditions characterised by impaired lymphatic flow,
including fibrotic diseases of the kidney, liver and other
organs.
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 affiliates, 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.
Forward Looking Statement
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, 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 Tom Donovan
+1 617 651 3156 +44 (0) 20 3727 1000 +1 857 559 3397
amt@puretechhealth.com ben.atwell@FTIconsulting.com tom@tenbridgecommunications.com
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
NRAEAEDDELEEEEA
(END) Dow Jones Newswires
March 03, 2020 02:00 ET (07:00 GMT)
Puretech Health (LSE:PRTC)
Historical Stock Chart
From Jun 2024 to Jul 2024
Puretech Health (LSE:PRTC)
Historical Stock Chart
From Jul 2023 to Jul 2024