TIDMPRTC
PureTech Health PLC
03 December 2020
3 December 2020
PureTech Health plc
PureTech Initiates Phase 2 trial of LYT-100 (Deupirfenidone) in
Long COVID Respiratory Complications and Related Sequelae
COVID-19 survivors may be at risk for persistent complications,
a condition referred to as Long COVID or Long Haul COVID
LYT-100, an anti-fibrotic and anti-inflammatory agent, holds
potential for treating inflammation and fibrosis implicated in a
range of respiratory conditions, including those associated with
COVID-19
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 its global, Phase 2 trial of LYT-100 (deupirfenidone) in Long
COVID respiratory complications and related sequelae. 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. The initiation
follows the completion of a Phase 1 multiple ascending dose and
food effect study for LYT-100, which demonstrated favorable
proof-of-concept for LYT-100's tolerability and pharmacokinetic
(PK) profile.
Fibrosis and inflammation are common mechanisms across several
lung diseases, and there is increasing data that respiratory
complications of SARS-CoV-2 (COVID-19), including shortness of
breath, begin during the acute phase of illness and may persist as
lung fibrosis develops. Similar respiratory complications caused by
Severe Acute Respiratory Syndrome (SARS) lasted for years in many
survivors. According to a research letter published in the Journal
of the American Medical Association (JAMA), more than 40 percent of
COVID-19 survivors assessed in an Italian study still reported
shortness of breath an average of 60 days following symptom
onset.[1] These data suggest that a significant percentage of
COVID-19 survivors may be at risk for respiratory complications and
other sequelae, which is a condition that is now colloquially
referred to as "Long COVID."
"COVID-19 is a global public health crisis with severe and
long-lasting effects. Patients around the world have reported
persistent suffering, including serious respiratory complications
that can last for months after the acute infection resolves, and -
even with vaccines - there is great a need for treatment options
for Long COVID , " said Toby Maher, M.D., Ph.D., professor of
clinical medicine and director of interstitial lung disease at Keck
School of Medicine of the University of Southern California and the
principal investigator on PureTech's Long COVID Phase 2 trial .
"The anti-fibrotic and anti-inflammatory properties of LYT-100 hold
potential for treating a range of respiratory conditions, including
the long-lasting health burden associated with post-acute COVID-19
. I am encouraged by the data generated with LYT-100 to date, and I
am excited to be involved in this trial addressing a critically
important public health need in the current COVID-19 pandemic."
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. Pirfenidone
is currently approved for the treatment of idiopathic pulmonary
fibrosis (IPF), but it is associated with significant tolerability
issues and dose-limiting toxicities. LYT-100, a new chemical
entity, retains the pharmacology of pirfenidone but has a
differentiated PK profile, which is designed to enable improved
tolerability, less frequent dosing and potentially increased
efficacy.
PureTech's global, randomized, double-blind, placebo-controlled
Phase 2 trial is designed to evaluate the efficacy, safety and
tolerability of LYT-100 in adults with post-acute COVID-19
respiratory complications. The primary endpoint of the trial will
be the six-minute walk test distance. Secondary endpoints,
including pharmacokinetics, inflammatory biomarkers, imaging and
patient-reported outcomes including dyspnea and the 36-Item Short
Form Health Survey, will also be evaluated. The study has initiated
in both the United States and Europe, and results are expected in
the second half of 2021.
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 has initiated a Phase 2 trial evaluating LYT-100 as a
potential treatment for Long COVID respiratory complications and
related sequelae. PureTech also intends to initiate a Phase 2a
proof-of-concept study evaluating LYT-100 in patients with breast
cancer-related, upper limb secondary lymphedema in Q4 2020.
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, the expected timing of results from our Phase 2 trial
of LYT-100, our plans and timing for a Phase 2a proof-of-concept
study evaluating LYT-100 in patients with breast cancer-related,
upper limb secondary lymphedema 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
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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
[1] Carfì, A., Bernabei, R., & Landi, F. (2020). Persistent
Symptoms in Patients After Acute COVID-19. Jama, 324(6), 603.
doi:10.1001/jama.2020.12603
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