TIDMPRTC
PureTech Health PLC
17 July 2019
17 July 2019
PureTech Health plc
PureTech Acquires New Clinical-Stage Programme LYT-100 to Treat
Lymphedema
Wholly owned programme adds to Company's growing internal
pipeline focused on lymphatic targeting and tissue-selective
immunomodulation
Clinical proof-of-concept study in adults with secondary
lymphedema planned for 2020
PureTech Health plc (LSE: PRTC) ("PureTech"), an advanced
biopharmaceutical company developing novel medicines for
dysfunctions of the Brain-Immune-Gut (BIG) axis, today announced it
has acquired and plans to develop a clinical-stage product
candidate for the potential treatment of lymphatic and
immunofibrotic diseases, including lymphedema. In preclinical
studies, the oral, small molecule candidate, LYT-100, demonstrated
anti-fibrotic and anti-inflammatory mechanisms, and in a Phase 1
clinical trial in healthy volunteers, LYT-100 was observed to be
well tolerated with a favourable pharmacokinetic profile to support
twice daily oral dosing. LYT-100 expands PureTech's internal
R&D pipeline and continues its progress in developing new
medicines based on insights into the lymphatic system and local
modulation of the immune system for the treatment of immune and
central nervous system disorders, lymphatic conditions, and
cancers.
"Lymphedema is a chronic and incurable secondary disease
affecting millions of people, and there has been far too little
progress made toward the development of meaningful treatments,"
said Joe Bolen, Ph.D., chief scientific officer of PureTech. "There
are no approved drug therapies on the market that can treat
lymphedema. PureTech is working to address this need by pioneering
an approach designed to target the underlying fibrosis and
inflammation affecting the lymphatics to potentially improve
lymphatic function and decrease the symptoms of lymphedema. We look
forward to advancing clinical studies and continuing to progress
the development of this candidate."
Lymphedema is one of the most common lymphatic diseases. It is a
chronic condition that afflicts millions of people and is
characterised by severe swelling in parts of the body - usually in
the arms or legs - due to the build-up of lymph fluid and
inflammation, fibrosis, and adipose deposition. The most prevalent
form of the condition, secondary lymphedema, is frequently caused
by cancer treatments or infections resulting in damage to or the
removal of lymph nodes. For example, of the more than 250,000
Americans diagnosed with breast cancer each year, up to one in five
who receive surgery will develop secondary lymphedema. The current
standards of care for lymphedema - compression and physical therapy
- are cumbersome and non-curative approaches that cannot correct
immune cell infiltration or regenerate the dysregulated lymphatics.
If left untreated, lymphedema can lead to disfigurement, severe
pain, disability, infection, and fibrosis. PureTech's product
candidate, LYT-100, has the potential to fulfil a widespread need
for an effective approach that can treat secondary lymphedema
without surgery.
"PureTech is committed to developing a long-awaited treatment
for the millions of people living with lymphedema, " said Daphne
Zohar, co-founder and chief executive officer of PureTech. "LYT-100
was identified for our internal pipeline through our expertise in
the lymphatic system, and it is the first clinical candidate to
advance from an ongoing sourcing effort that builds on insights
from our team and our network of collaborators and key opinion
leaders in the field. We also expect to advance other candidates in
pilot clinical studies, and we will progress the ones with the most
favourable clinical profile."
LYT-100, an oral small molecule with well-established
preclinical anti-fibrotic activity, has been previously studied in
healthy volunteers as part of a Phase 1, single ascending dose
study. PureTech will continue clinical development in healthy
volunteers, looking at additional safety and pharmacokinetics of
LYT-100 prior to initiating a human biomarker and proof-of-concept
study expected in 2020. LYT-100 was acquired from a large
pharmaceutical company where it was originally being developed in
another indication.
About Lymphedema
Lymphedema is a chronic condition characterised by severe
swelling of the limbs or other tissues due to the build-up of fluid
that would normally be drained by the lymphatic system. The most
prevalent form of the condition, secondary lymphedema, is
frequently caused by cancer treatments or infections resulting in
damage to or the removal of lymph nodes. Millions of Americans are
affected by the condition, which typically progresses through
multiple stages marked by increased fibrosis, limb volume, and
tissue changes, ultimately resulting in disfigurement, severe pain,
disability, and infection. The current standard of care for
lymphedema include compression, physical therapy, and surgery to
help reduce symptoms, but none address the underlying condition.
There are currently no FDA-approved therapeutics to treat
lymphedema, suggesting a major need for millions of patients.
About PureTech
PureTech (LSE: PRTC) is an advanced biopharmaceutical company
developing highly differentiated medicines for dysfunctions of the
Brain-Immune-Gut (BIG) axis. The company has gained deep insights
into the connection between these systems and the resulting role in
diseases that have been resistant to established therapeutic
approaches. By harnessing this emerging field of human biology,
PureTech is developing new categories of medicines with the
potential to have great impact on people with serious
disorders.
PureTech is advancing a rich pipeline of innovative therapies
with an unbiased, nimble, and capital efficient R&D model
across its affiliates and its internal R&D pipeline. PureTech's
pipeline comprises more than two dozen product candidates,
including several clinical-stage programmes, one product that has
been cleared by the US Food and Drug Administration (FDA), and a
second product candidate that has been filed with the FDA for
review. The PureTech pipeline includes ground-breaking platforms
and therapeutic candidates that were developed in collaboration
with some of the world's leading experts.
PureTech's internal pipeline is centred on lymphatic targeting
and tissue-selective immunomodulation for the potential treatment
of immune and central nervous system disorders, lymphatic
conditions, and cancers. The company is advancing multiple
platforms to enable oral administration of therapies directly into
the lymphatic system, regulate lymphatic flow and function, and
target immunosuppressive mechanisms in oncology. 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
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END
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July 17, 2019 02:00 ET (06:00 GMT)
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