TIDMPRTC
PureTech Health PLC
28 May 2020
28 May 2020
PureTech Health plc
PureTech Advances LYT-100 (Deupirfenidone) for Treatment of
Serious Respiratory Complications that Persist Following Resolution
of COVID-19 Infection
Emerging data suggest many of the millions infected with
COVID-19 may be at risk for long-term pulmonary dysfunction,
including fibrosis
LYT-100 is an orally administered anti-inflammatory and
anti-fibrotic with the potential to treat a range of lung
complications, including those resulting from COVID-19
Global, randomised, placebo-controlled trial of LYT-100 in
patients with COVID-19 is expected to begin in Q3 2020
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 plans to advance its
wholly-owned clinical-stage product candidate LYT-100
(deupirfenidone) as a potential treatment for serious respiratory
complications, including inflammation and fibrosis, that persist
following the resolution of SARS-CoV-2 (COVID-19) infection.
LYT-100 employs a multimodal mechanism of action to potentially
reduce, delay or prevent the lung dysfunction that has recently
been documented in COVID-19 patients, including those who have
recovered from the infection. The global, randomised,
placebo-controlled trial is expected to begin in Q3 2020 and will
evaluate LYT-100 in non-critical COVID-19 patients with respiratory
complications. Patients will continue treatment for up to three
months.
"Hundreds of clinical trials are underway to combat COVID-19,
but the vast majority are focused on vaccines or the acute
treatment of severe patients," said Dennis Ausiello, MD, former
chief of medicine at Massachusetts General Hospital and a member of
the PureTech R&D Committee. "As we learn more about the full
impact of COVID-19 on the body, we're seeing post-recovery,
longer-term pulmonary dysfunction similar to that observed
following infection with other coronaviruses, including SARS and
MERS. In fact, emerging data suggest that a high proportion of
COVID-19 patients are at risk of impaired lung function and
fibrosis after recovery, as well as during acute infection. With
more than five million documented infections to date worldwide,
there is a clear and urgent need for therapeutics to address the
longer-term sequalae of COVID-19."
LYT-100 is an oral anti-fibrotic and anti-inflammatory small
molecule. It is a deuterated analogue of pirfenidone. Oral
pirfenidone is approved for the treatment of idiopathic pulmonary
fibrosis (IPF) in the United States, European Union, Japan and a
number of other countries and has received Breakthrough Therapy
designation from the FDA for unclassifiable interstitial lung
disease. In prior Phase 1, healthy volunteer studies, LYT-100 has
shown a differentiated and superior pharmacokinetic profile
compared to pirfenidone, suggesting improved efficacy, tolerability
and safety, while retaining the same intrinsic pharmacology of
pirfenidone. Preclinical research also shows that LYT-100 potently
inhibits a range of pro-inflammatory cytokines including IL6, TNF
alpha and TGF-beta.
"Many interstitial lung diseases (ILDs) are characterised by
inflammation and fibrosis, which can result in impaired lung
function and progressive pulmonary fibrosis. Interstitial pneumonia
and ILD are manifestations of some viral infections in a subgroup
of patients in the short term and may persist for months or years
in another subgroup of patients who survive following severe acute
respiratory syndrome (SARS) associated with coronavirus, " said
Ganesh Raghu, MD, professor of medicine and adjunct professor of
laboratory medicine at the University of Washington (UW) and
director of the Center for Interstitial Lung Disease at UW
Medicine. "Certain pathobiological features of COVID-19 are similar
to features of interstitial pneumonia and acute exacerbations of
fibrotic lung diseases. Therapeutic strategies targeting pathways
of immune dysregulation, innate immunity, inflammation and fibrosis
are appropriate to consider as potential treatments of COVID-19 and
fibrotic ILD in the context of clinical trials."
"PureTech has always been driven to help patients through
innovation in medicine, and our LYT-100 programme in COVID-19
represents another example of this commitment," said Eric Elenko,
PhD, chief innovation officer at PureTech. "The unique
anti-fibrotic and anti-inflammatory properties of LYT-100 may have
therapeutic potential in a range of conditions, including other
interstitial lung diseases as well as lymphoedema, for which a
trial is planned to begin in 2020."
PureTech expects to initiate a global, multi-centre, randomised,
double-blinded, placebo-controlled trial in Q3 2020 to evaluate the
efficacy, safety and tolerability of LYT-100 in non-critical
COVID-19 patients with respiratory complications. Patients will
continue treatment for up to three months. The trial is expected to
enrol approximately 150 patients, with a primary endpoint measuring
pulmonary function testing. The trial will also assess exploratory
endpoints including pharmacokinetics, acute inflammatory
biomarkers, hospitalisation events, imaging and patient-reported
outcomes. PureTech expects to announce topline results in
mid-2021.
As previously announced, in March 2020 PureTech initiated a
Phase 1 trial of LYT-100 evaluating its safety, tolerability and
the pharmacokinetic profile of multiple doses in healthy
participants. Results from this trial are anticipated later this
year, and a subsequent proof-of-concept trial in people with breast
cancer-related, upper limb secondary lymphoedema is expected to
begin in 2020, with topline results expected in 2021. PureTech is
also evaluating additional inflammatory and fibrotic conditions
that could potentially be addressed with LYT-100.
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
developed for the potential treatment of a range of conditions
involving fibrosis, inflammation and impaired lymphatic flow,
including lymphoedema, idiopathic pulmonary fibrosis (IPF),
interstitial pneumonias, unclassifiable interstitial lung disease
(uILD) and other interstitial lung disease (ILD), radiation-induced
fibrosis and focal segmental glomerulosclerosis (FSGS). LYT-100 is
currently being evaluated in a Phase 1 multiple ascending dose and
food effect trial in healthy volunteers with a subsequent
assessment in patients with breast cancer-related, upper limb
secondary lymphoedema expected to begin in 2020. PureTech also
plans to initiate a trial in Q3 2020 evaluating LYT-100 as a
potential treatment for serious respiratory complications,
including inflammation and fibrosis, that persist following the
resolution of SARS-CoV-2 (COVID-19).
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 Founded Entities,
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.
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to, those risks and uncertainties described in the risk factors
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neither the company nor any other party intends to update or revise
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Contact:
Investors EU media US media
Allison Mead Talbot Ben Atwell, Rob Winder Stephanie Simon
+1 617 651 3156 +44 (0) 20 3727 1000 +1 617 581 9333
amt@puretechhealth.com ben.atwell@FTIconsulting.com stephanie@tenbridgecommunications.com
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END
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