No treatment effect observed in this patient
population; substantial improvement in 6-minute walk test seen in
both placebo and active groups
Study adds to growing body of data supporting
strong safety and tolerability profile of LYT-100
(deupirfenidone)
Company will drive LYT-100 forward in other
indications, with a focus on IPF where human clinical efficacy has
been previously shown with pirfenidone
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 results from a
Phase 2 study of LYT-100-COV (deupirfenidone) in patients with
post-acute “Long” COVID with respiratory complications. There was
no treatment effect observed in this indication with LYT-100,
though the strong safety and tolerability profile of LYT-100 seen
in previous studies was reaffirmed. Based on these data, PureTech
will not pursue further studies in this patient population and
remains on track to initiate registration-enabling studies of
LYT-100 in idiopathic pulmonary fibrosis (IPF) later this month.
LYT-100 is a selectively deuterated form of pirfenidone.
Pirfenidone has been proven effective in IPF, a devastating
condition where the tolerability, safety and potentially higher
exposure of LYT-100 could have an important impact on patient
adherence and outcomes.
“Early in the COVID-19 pandemic, we identified a potential
application for LYT-100 given the hypothesis that inflammation and
fibrosis may play a role in prolonging respiratory symptoms
experienced by many patients. We undertook this exploratory study,
guided by a desire to address this emerging need, while further
expanding the safety and tolerability data for our LYT-100
development program at large,” said Daphne Zohar, Founder and Chief
Executive Officer of PureTech. “Although we had hoped to offer a
treatment to Long COVID patients, these data further strengthen our
confidence that LYT-100 has the potential to offer improved
tolerability and therefore potentially improved treatment adherence
and patient outcomes in IPF, a devastating condition that has been
well-studied and where pirfenidone has proven efficacy. We are very
grateful to the participants and researchers who were involved in
this study, and we believe this additional tolerability and safety
data will help to support our registration-enabling program in IPF,
which we plan to initiate later this month.”
The global, double-blind, randomized, placebo-controlled study
is one of few to complete in patients with post-acute COVID. The
study enrolled 177 patients averaging 55 years of age who
experienced continued respiratory complications following
hospitalization for acute COVID-19 infection that required
treatment with supplemental oxygen. The primary efficacy endpoint
was a three-month change from baseline compared to placebo on the
six-minute walk test (6MWT) distance. The 6MWT determines how far a
patient can walk in six minutes and is a commonly used measure of
functional capacity in a variety of cardio-pulmonary diseases.
Individuals in both the treatment and placebo arms meaningfully
improved walking distance on the 6MWT as compared to baseline, and
no statistically significant differences between treatment groups
were observed.
"This was a well-executed study that sought to understand
whether survivors of severe COVID-19 pneumonia might benefit from
treatment with an anti-fibrotic therapy following discharge from
hospital. Importantly, the study demonstrated that – in contrast to
patients with IPF who inevitably decline – the majority of the
COVID-19 patients studied experienced meaningful functional
improvements over time, independent of treatment arm,” said Toby
Maher, M.D., Ph.D., Professor Clinical Medicine and Director of
Interstitial Lung Disease at Keck School of Medicine of the
University of Southern California and Principal Investigator of the
study. “To me, a key takeaway from the study was the strong safety
and tolerability profile of LYT-100. This, coupled with the
established efficacy of pirfenidone, encourages me to believe that
LYT-100 has the potential to be an important treatment option for
patients with idiopathic pulmonary fibrosis, a progressive and life
shortening disorder of the lungs that is quite distinct from the
acute lung injury seen with COVID-19.”
LYT-100 was well-tolerated in this relatively sick patient
population with multiple comorbidities and concomitant medications.
There were no drug-related serious adverse events (SAEs) or deaths.
Nausea was the only AE judged to be at least possibly related to
LYT-100 with an incidence ≥5% (8.7% vs 2.4% with placebo). Other
AEs that have been commonly associated with pirfenidone and were
considered to be at least possibly related to LYT-100 treatment
included headache (4.3% vs. 1.2% with placebo), dizziness (3.3% vs.
1.2% with placebo), fatigue (2.2% vs. 0% with placebo), and rash
(3.3% vs. 1.2% with placebo). Discontinuation rates due to AEs that
were considered at least possibly related to LYT-100 were low in
both arms (8.6% with LYT-100 vs. 2.4% with placebo) and the
majority of discontinuations in the LYT-100 arm were due to
idiosyncratic events and not AEs commonly associated with
pirfenidone.
These results are consistent with the previously demonstrated
safety and tolerability profile of LYT-100, including the recently
announced results of a crossover study in healthy older adults,
which showed that approximately 50% fewer subjects experienced
gastrointestinal-related AEs with LYT-100 compared with pirfenidone
(17.4% vs. 34.0%) and that substantially fewer subjects experienced
AEs with LYT-100 vs. pirfenidone. PureTech has also recently shown
that LYT-100 can be safely dosed with a higher total drug exposure
than the currently approved dose of pirfenidone, which could
translate into improved efficacy over pirfenidone. The safety and
tolerability data generated to date with LYT-100, along with the
established efficacy of pirfenidone in IPF, support the advancement
of registration-enabling studies of LYT-100 in IPF.
“Our limited understanding of post-acute COVID-19 makes this
therapeutic area particularly challenging for a variety of reasons,
yet this trial yielded some important insights into this patient
population and the natural recovery process of patients,” said
Robert A. Wise, M.D., Chair of the Data and Safety Monitoring
Board. “The disease course in patients with acute COVID-19 is
mostly self-limiting and differs significantly from that of a
chronic, progressive disease like IPF, where patients do not
improve over time without intervention. I am particularly pleased
to see how well-tolerated LYT-100 was in this relatively sick
patient population, which suggests that it will also be
well-tolerated in IPF.”
PureTech intends to share these data with clinicians to further
the understanding of the natural history of post-acute COVID-19.
These data will also be included in future filings to support the
safety and tolerability of LYT-100.
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 with a differentiated
pharmacokinetic profile that has translated into favorable
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
idiopathic pulmonary fibrosis and breast cancer-related, upper limb
secondary lymphedema. PureTech is also exploring the potential
evaluation of LYT-100 in other inflammatory and fibrotic conditions
such as myocardial and other organ system fibrosis based on the
strength of existing clinical data around the use of pirfenidone in
these indications.
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, the treatment potential of
LYT-100, including its ability to address a significant unmet need
for patients with IPF, its potential to have improved tolerability
as compared to pirfenidone and to have an impact on patient
adherence and outcomes, our intention to conduct no further studies
in patients experiencing Post-Acute “Long” COVID with Respiratory
Complications 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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U.S. Media Nichole Sarkis +1 774 278 8273
nichole@tenbridgecommunications.com
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