LYT-100 was well-tolerated compared to
pirfenidone in a healthy older adult crossover trial, informing
dose selection for recently initiated trial in IPF
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company dedicated to
changing the treatment paradigm for devastating diseases, today
announced a poster presentation describing the rationale and design
for the Phase 2 trial of LYT-100 in patients with IPF at the
European Respiratory Society (ERS) International Congress. The
poster also reviews the results from a Phase 1 crossover trial of
LYT-100 in healthy older adults, which supports the dose selection
for the Phase 2 trial. LYT-100 is a therapeutic candidate in
PureTech’s Wholly Owned Pipeline and is being advanced for the
treatment of conditions involving inflammation and fibrosis,
including IPF.
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PureTech announced a poster presentation
describing the rationale and design for the Phase 2 trial of
LYT-100 in patients with IPF at the European Respiratory Society
(ERS) International Congress. The poster also reviews the results
from a Phase 1 crossover trial of LYT-100 in healthy older adults,
which supports the dose selection for the Phase 2 trial. (Graphic:
Business Wire)
The data from the Phase 1 trial demonstrated that LYT-100 showed
a lower incidence of adverse events (AEs) compared to pirfenidone
at comparable exposure levels. Key outcomes of this trial that are
supportive of the observed improved tolerability of LYT-100 were
reported in January 2022. Additionally, this trial supports the
dosages that were selected for the Phase 2 trial of LYT-100, which
began in June 2022.
“These Phase 1 data provide additional evidence of LYT-100’s
tolerability compared to pirfenidone and further support testing a
higher dose of LYT-100 in our dose-ranging clinical trial in
patients with IPF,” said Julie Krop, M.D., Chief Medical Officer at
PureTech. “Pirfenidone’s tolerability profile impacts patient
adherence to an otherwise efficacious IPF treatment, resulting in
dose adjustments, discontinuations and ultimately poorer patient
outcomes. We’re encouraged by the data we’ve seen thus far and we
look forward to progressing our Phase 2 trial in patients living
with IPF.”
LYT-100 is a selectively deuterated form of pirfenidone that is
designed to retain the potent and clinically validated
anti-fibrotic and anti-inflammatory activity of pirfenidone with a
differentiated pharmacokinetic (PK) profile that has translated
into favorable safety and tolerability, as demonstrated by data
from more than 400 subjects. Pirfenidone is one of the two standard
of care treatments approved for IPF, along with nintedanib, both of
which are efficacious but associated with significant GI-related
tolerability issues. The tolerability issues associated with
pirfenidone result in treatment discontinuations and/or dose
reductions below the FDA-approved dose of 801 mg three times a day
(TID), thereby limiting its effectiveness in patients.
"For a devastating and progressive disease like IPF, more
tolerable and effective treatment options are critical to curbing
premature discontinuation or sub-optimal dosing," said Toby Maher,
M.D., Ph.D., Professor of Medicine at Keck Medicine of USC Academic
Medical Center at the University of Southern California who is
presenting the poster at ERS and is an investigator in the
dose-ranging trial. "The tolerability advantage of LYT-100 over
pirfenidone may enable better patient compliance and potentially
lead to improved outcomes, both for those currently taking standard
of care drugs and – perhaps more importantly – for the
approximately 75% of patients with IPF who are not currently on any
approved therapies, often due to tolerability issues.”
Phase 1 safety results in healthy older adults
The Phase 1 trial was a double-blind, randomized, two-period
crossover trial of LYT-100 conducted in healthy older adults in the
fed state to determine the safety, tolerability and PK parameters
of LYT-100 administered TID for three days compared to pirfenidone
administered TID for three days under fed conditions. Subjects were
randomized to one of two treatment sequences.
Results from the Phase 1 trial were announced in January 2022.
The expanded analysis details the safety, tolerability and
favorable PK profile of LYT-100 at the 550 mg TID dose in fed
healthy volunteers. LYT-100 550 mg TID administration substantially
reduced incidence of GI (50% reduction) and nervous system (45%
reduction) related treatment-emergent adverse events (TEAEs)
compared to pirfenidone in this crossover trial, consistent with a
lower Cmax. The demonstrated tolerability supports testing a higher
dose of LYT-100 in the IPF trial.
Dose-ranging trial (ELEVATE) design
The scientific poster also reviews the design of PureTech’s
dose-ranging trial of LYT-100 in patients with IPF. The clinical
trial’s primary objective will be focused on obtaining clinical
data establishing the efficacy, tolerability, safety and dosing
regimen of LYT-100 compared to placebo in order to determine the
dose for a potential Phase 3 trial. The primary efficacy endpoint
is the rate of decline in Forced Vital Capacity (FVC) over 26
weeks. The secondary endpoints include change in FVC percentage
predicted from baseline to week 26, time to hospitalization or
mortality due to respiratory cause through 26 weeks and time to IPF
progression through 26 weeks, as defined by a decline in FVC
percentage of greater than or equal to five percent. Both doses of
LYT-100 will be compared to placebo and pirfenidone with respect to
safety and efficacy during the 26-week trial.
The global IPF ELEVATE trial has initiated and is enrolling
patients. Visit clinicaltrial.gov (NCT05321420) for more
details.
About Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis is a terminal, 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 leave patients and physicians needing new
treatment options.
About LYT-100
LYT-100 is one of seven therapeutic candidates within PureTech's
Wholly Owned Pipeline. It is a selectively deuterated form of
pirfenidone that is designed to retain the potent and
clinically-validated anti-fibrotic and anti-inflammatory activity
of pirfenidone but has a highly differentiated PK profile that has
translated into improved tolerability, as supported by data from
multiple human clinical studies. LYT-100 is being advanced for the
potential treatment of conditions involving inflammation and
fibrosis, including IPF. PureTech is also exploring the potential
evaluation of LYT-100 in other inflammatory and fibrotic conditions
such as myocardial and other organ system fibrosis, radiation
induced fibrosis, and lymphedema based on the strength of existing
clinical data around the use of pirfenidone in these
indications.
About PureTech Health
PureTech is a biotherapeutics company dedicated to changing the
treatment paradigm for devastating diseases. 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 and a third that
will soon be filed for FDA approval, as of the date of PureTech's
most recently filed Half-Year 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 trial of LYT-100 for the treatment of
idiopathic pulmonary fibrosis, the treatment potential of LYT-100
for patients with idiopathic pulmonary fibrosis, 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, 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
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