LYT-100 demonstrated ~50% improvement versus
pirfenidone in key adverse events at a comparable exposure level,
which may lead to better patient compliance and improved treatment
outcomes in IPF
LYT-100 also demonstrated favorable
tolerability at a 43% higher exposure level, supporting the
exploration of a higher dose for potentially enhanced efficacy in
IPF
Results informed dose selection for ongoing,
global Phase 2b ELEVATE IPF trial, with topline data expected in
2024
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company dedicated to
changing the lives of patients with devastating diseases, presented
clinical data supporting the differentiated profile of LYT-100
(deupirfenidone) at the CHEST Annual Meeting in Honolulu,
Hawaii.
The presentation expands on data from a completed trial of
LYT-100 in healthy older adults, which informed the two doses
selected for the ongoing, global Phase 2b dose-ranging trial of
LYT-100 (ELEVATE IPF) in patients with idiopathic pulmonary
fibrosis (IPF). In addition to supporting the improved tolerability
of LYT-100 versus the FDA-approved dose of pirfenidone, the data
provide insights into the selection of the higher dose of LYT-100
that is also being evaluated in ELEVATE IPF.
The trial showed that a 550 mg dose of LYT-100 given three times
daily (TID) provided bioequivalent drug exposure to the
FDA-approved dose of pirfenidone, 801 mg TID. LYT-100 also
demonstrated a 24% lower peak drug concentration than pirfenidone,
which is a key factor generally associated with tolerability. As
previously announced, this dose also achieved an approximately 50%
reduction in participants experiencing gastro-intestinal (GI) and
central nervous system (CNS)-related adverse events (AEs) compared
to those taking pirfenidone.
Additionally, the data showed that a higher dose of LYT-100 (824
mg TID), which achieved a 43% higher exposure level, was
well-tolerated with no additional incidence of GI or CNS AEs when
titrated up from LYT-100 550 mg TID in this trial, supporting the
potential to provide enhanced efficacy with favorable tolerability
in IPF. This hypothesis is supported by Phase 3 data with
pirfenidone that showed a dose-response effect on forced vital
capacity and survival in people with IPF.1 PureTech is therefore
investigating the efficacy and tolerability of LYT-100 at 550 mg
TID and 825 mg TID in the Phase 2b ELEVATE IPF trial.
“These data highlight the potential for LYT-100 to improve both
the treatment experience for people with IPF and – most importantly
– enable them to stay on treatment longer and at an efficacious
dose, which should improve their clinical outcomes,” said Julie
Krop, M.D., Chief Medical Officer of PureTech Health. “Our goal
with the ELEVATE IPF trial is to validate the ability of LYT-100 to
deliver a more tolerable treatment with equivalent efficacy to
pirfenidone at one dose while also exploring the potential for
enhanced efficacy at a higher dose.”
“Tolerability is a major challenge with the currently available
IPF treatments, and it often results in both temporary and
permanent dose reductions, premature discontinuation and a
reluctance for patients to even begin treatment,” said Dr. Toby
Maher, M.D., Ph.D., Professor of Medicine and Director of
Interstitial Lung Disease at Keck School of Medicine, University of
Southern California, Los Angeles, who is presenting the poster at
CHEST and is an investigator in the ELEVATE IPF trial. “The unique
profile of deupirfenidone may offer not only improved tolerability,
but it also provides us with the opportunity to assess whether a
higher dose is associated with improved efficacy – a strategy that
has not been possible to test with pirfenidone due to its poor
tolerability. This may benefit both patients currently taking
standard-of-care antifibrotic drugs as well as the 75% of people
with IPF in the US who are not on treatment. The IPF treatment
landscape is in desperate need of new therapeutic approaches that
can be used either as monotherapies or as the backbone for
combination therapy, and I look forward to the results of the
ELEVATE IPF trial.”
About Idiopathic Pulmonary Fibrosis (IPF) Idiopathic
pulmonary fibrosis (IPF) is a rare, progressive and fatal lung
disease with a median survival of 2-5 years.2 Pirfenidone is one of
only two drugs approved to treat IPF, and it has been shown to
improve survival by approximately three years compared to
supportive care alone.2 However, tolerability issues with both of
the standard-of-care drugs result in patients discontinuing
treatment or reducing their dose. As a result, nearly three out of
every four people with IPF forego treatment with these otherwise
efficacious medicines.3
About LYT-100 (Deupirfenidone) LYT-100 (deupirfenidone)
is being advanced for the treatment of conditions involving
inflammation and fibrosis, including idiopathic pulmonary fibrosis
(IPF). It is a deuterated form of pirfenidone that is designed to
retain the beneficial pharmacology and clinically-validated
efficacy of pirfenidone with a highly differentiated
pharmacokinetic (PK) profile. This PK profile has translated into
favorable tolerability as demonstrated across multiple clinical
studies in more than 400 individuals.
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 tolerability issues.
These tolerability issues result in treatment discontinuations
and/or dose reductions below the FDA-approved dose, thereby
limiting the effectiveness of these otherwise efficacious
medicines. With LYT-100, PureTech aims to deliver better outcomes
for patients by enabling individuals to maintain the same or higher
doses for longer. PureTech believes LYT-100 has the potential both
to supplant the current standard-of-care treatments and to serve a
larger market of patients who are unable to tolerate current
therapies.
For more information on the global, Phase 2b ELEVATE IPF trial,
visit clinicaltrials.gov (NCT05321420). Those in the United States
may also visit ELEVATEIPF.com.
About PureTech Health PureTech is a clinical-stage
biotherapeutics company dedicated to giving life to new classes of
medicine to change the lives of patients with devastating diseases.
The Company has created a broad and deep pipeline through its
experienced research and development team and its extensive network
of scientists, clinicians and industry leaders that is being
advanced both internally and through its Founded Entities.
PureTech's R&D engine has resulted in the development of 27
therapeutics and therapeutic candidates, including two (Plenity®
and EndeavorRx®) that have received both US FDA clearance and
European marketing authorization and a third (KarXT) that has been
filed for FDA approval. A number of these programs are being
advanced by PureTech or its Founded Entities in various indications
and stages of clinical development, including registration enabling
studies. 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.
For more information, visit www.puretechhealth.com or connect
with us on X, formerly known as Twitter, @puretechh.
Cautionary Note Regarding Forward-Looking Statements This
press release contains 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 without limitation those statements that
relate to our hypotheses and expectations around the treatment
potential associated with LYT-100, including potential tolerability
and efficacy benefits as compared to the current standard of care
for IPF patients, our product 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, 2022 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.
1 King, T. E., Bradford, W. Z., Castro-Bernardini, S., Fagan, E.
A., Glaspole, I., Glassberg, M. K., Gorina, E., Hopkins, P.,
Kardatzke, D., Lancaster, L., Lederer, D. J., Nathan, S. D., De
Castro Pereira, C. A., Sahn, S. A., Sussman, R., Swigris, J. J.,
& Noble, P. W. (2014). A Phase 3 Trial of Pirfenidone in
Patients with Idiopathic Pulmonary Fibrosis. The New England
Journal of Medicine, 370(22), 2083–2092.
https://doi.org/10.1056/nejmoa1402582 2 Fisher, M., Nathan, S. D.,
Hill, C., Marshall, J., Dejonckheere, F., Thuresson, P., &
Maher, T. M. (2017). Predicting Life Expectancy for Pirfenidone in
Idiopathic Pulmonary Fibrosis. Journal of Managed Care &
Specialty Pharmacy, 23(3-b Suppl), S17–S24.
https://doi.org/10.18553/jmcp.2017.23.3-b.s17 3 Dempsey, T., Payne,
S. C., Sangaralingham, L. R., Yao, X., Shah, N., & Limper, A.
H. (2021). Adoption of the Antifibrotic Medications Pirfenidone and
Nintedanib for Patients with Idiopathic Pulmonary Fibrosis. Annals
of the American Thoracic Society, 18(7), 1121–1128.
https://doi.org/10.1513/annalsats.202007-901oc
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