Further data from Phase 1 study in healthy
older adults demonstrate improved tolerability profile of LYT-100
compared to pirfenidone
Data support the planned LYT-100 dose-ranging
registration-enabling studies in idiopathic pulmonary fibrosis,
with topline results expected in 2023
PureTech Health plc (Nasdaq: PRTC, LSE: 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
presentation of additional data for PureTech’s LYT-100
(deupirfenidone) at the American Thoracic Society 2022
International Conference. The data were shared in a scientific
poster session and detailed the outcomes of a study in healthy
older adults showing that LYT-100 demonstrated a lower incidence of
adverse events (AEs) compared to pirfenidone at comparable exposure
levels. Key outcomes of this study that are supportive of the
observed improved tolerability of LYT-100 were reported in January
2022. The data support the upcoming registration-enabling studies
in which PureTech plans to investigate LYT-100 in patients with
idiopathic pulmonary fibrosis (IPF) at the planned 550 mg three
times daily dose (TID) as well as a dose with a higher total drug
exposure than the currently approved dose of pirfenidone to
evaluate if higher exposure could translate into improved
efficacy.
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PureTech today announced the presentation
of additional data for PureTech's LYT-100 (deupirfenidone) at the
American Thoracic Society 2022 International Conference. The data
were shared in a scientific poster session and detailed the
outcomes of a study in healthy older adults showing that LYT-100
demonstrated a lower incidence of adverse events (AEs) compared to
pirfenidone at comparable exposure levels. (Graphic: Business
Wire)
Pirfenidone is approved by the U.S. Food and Drug Administration
(FDA) for the treatment of IPF but is associated with significant
tolerability issues that LYT-100, as a deuterated form of
pirfenidone, is intended to reduce. PureTech intends to advance
LYT-100 into late-stage clinical development for the treatment of
IPF using a 505(b)(2) development path, beginning with a
dose-ranging study evaluating six months of treatment with LYT-100
with topline results expected by the end of 2023.
“Although approved antifibrotics for the treatment of IPF delay
the progression of lung fibrosis and increase life expectancy, a
large proportion of patients are unable to tolerate these
treatments, leading to premature discontinuation or sub-optimal
dosing,” said Michael Chen, Ph.D., Head of Innovation at PureTech
Health. “These data further support the favorable tolerability
profile of LYT-100, which has been studied in over 400 patients and
healthy volunteers to date. LYT-100 is designed to retain the
pharmacological activity of pirfenidone, but has a differentiated
pharmacokinetic profile which enables a lower peak systemic
concentration (Cmax), while still retaining AUC bioequivalence
compared with the standard dosing of pirfenidone. We believe the
lower Cmax we demonstrated at the 550 mg TID dose accounted for the
lower incidence of adverse events we observed in the study.”
The double-blind, randomized, crossover Phase 1 study evaluated
the tolerability of LYT-100 550 mg TID versus pirfenidone 801 mg
TID in 49 healthy older adults aged 60-79, an age group consistent
with that of the IPF patient population. As previously announced,
the study was supportive of an improved tolerability profile for
LYT-100 with 38% fewer subjects treated with LYT-100 experiencing
any AEs compared with those treated with pirfenidone (30.4% vs.
48.9%). The poster presented today details the incidence of AEs in
the study population including the reduction in incidence of AEs in
LYT-100 vs. pirfenidone administration in both fed and fasted
subjects. Notably, LYT-100 at 550 mg TID (fed state) dose met the
criteria for bioequivalence for exposure compared to the
FDA-approved dosage of pirfenidone – 801 mg TID – but with a lower
Cmax. Higher dosages of LYT-100 may provide enhanced antifibrotic
and anti-inflammatory activity.
The scientific poster presented today is available at
https://puretechhealth.com/LYT-100-ATS2022-poster.
About LYT-100
LYT-100 is PureTech's most advanced therapeutic candidate from
within its Wholly Owned Pipeline. 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, including lung disease (IPF and
post-acute COVID respiratory complications and related sequelae)
and disorders of lymphatic flow, such as lymphedema. PureTech is
also exploring the potential evaluation of LYT-100 in other
inflammatory and fibrotic conditions such as radiation induced
fibrosis, myocardial fibrosis and other organ system fibrosis based
on the strength of existing clinical data around the use of
pirfenidone in these indications.
In the fourth quarter of 2020, PureTech initiated a Phase 2
study evaluating LYT-100 as a potential treatment for post-acute
COVID respiratory complications and related sequelae and a Phase 2a
proof-of-concept study evaluating LYT-100 in patients with breast
cancer-related, upper limb secondary lymphedema. Enrollment in the
post-acute COVID respiratory complications study is complete, and
topline results are anticipated in the first half of 2022. Topline
results from the Phase 2a proof-of-concept breast cancer-related,
upper limb secondary lymphedema study are anticipated in 2022.
PureTech also expects to initiate registration-enabling studies of
LYT-100 in patients with IPF in the first half of 2022.
About Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis (IPF) is an orphan condition that
is progressive and characterized by irreversible scarring of the
lungs that worsens over time and makes it difficult to breathe. The
prognosis of IPF is poor, with the median survival after diagnosis
generally estimated at two to five years. Currently available
treatment options are associated with significant tolerability
issues and dose-limiting toxicities, which can hamper treatment
compliance and leaves patients and physicians needing new treatment
options.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercializing highly
differentiated medicines for devastating diseases, including
inflammatory, fibrotic and immunological conditions, intractable
cancers, lymphatic and gastrointestinal diseases and neurological
and neuropsychological disorders, 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 27
therapeutics and therapeutic candidates, including two that have
received both U.S. FDA clearance and European marketing
authorization, as of the date of PureTech's most recently filed
Annual Report and corresponding Form 6-K. All of the underlying
programs and platforms that resulted in this pipeline of
therapeutic candidates were initially identified or discovered and
then advanced by the PureTech team through key validation points
based on unique insights in immunology and drug development.
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 within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements contained
in this press release that do not relate to matters of historical
fact should be considered forward-looking statements, including
those related to our initiation of registration-enabling studies
with LYT-100 for the treatment of IPF with a streamlined 505(b)(2)
development path and the design and timing for the initiation of
the dose-ranging and Phase 3 studies supporting the clinical
development of LYT-100 for IPF in accordance with our development
plan, our belief that the results of these studies could serve as
the basis for registration of LYT-100 in the United States, the
treatment potential of LYT-100, including its ability to address a
significant unmet need for patients with IPF and certain
shortcomings with respect to current standards of care,
expectations regarding the potential of clinical data to support
clinical development of LYT-100 for indications beyond IPF, the
timing for topline results from our current Phase 2 post-acute
COVID respiratory and 2a proof-of-concept breast cancer-related,
upper limb secondary lymphedema studies of LYT-100, our therapeutic
candidates and approach towards addressing major diseases, and our
future prospects, developments and strategies. The forward-looking
statements are based on current expectations and are subject to
known and unknown risks, uncertainties and other important factors
that could cause actual results, performance and achievements to
differ materially from current expectations, including, but not
limited to, those risks, uncertainties and other important factors
described under the caption "Risk Factors" in our Annual Report on
Form 20-F for the year ended December 31, 2021 filed with the SEC
and in our other regulatory filings. 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, we disclaim any
obligation to update or revise these forward-looking statements,
whether as a result of new information, future events or
otherwise.
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PureTech Public Relations
publicrelations@puretechhealth.com Investor Relations
IR@puretechhealth.com
EU Media Ben Atwell, Rob Winder +44 (0) 20 3727 1000
ben.atwell@FTIconsulting.com
U.S. Media Nichole Sarkis +1 774 278 8273
nichole@tenbridgecommunications.com
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