TIDMPRTC
PureTech Health PLC
11 October 2023
October 11, 2023
PureTech Health plc
PureTech Presents Data from LYT-100 (Deupirfenidone) Trial in
Healthy Older Adults at CHEST Annual Meeting
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(R) and EndeavorRx(R)) 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.
Contact:
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
[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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