Three presentations inform clinical, commercial
and patient engagement strategies for LYT-100 for the treatment of
idiopathic pulmonary fibrosis (IPF)
Topline data from the Phase 2b ELEVATE IPF
trial of LYT-100 expected by the end of 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, today
announced its onsite presence at the CHEST 2024 Annual Meeting in
Boston, Massachusetts, from October 6-9. The Company will deliver
two oral presentations and one poster relating to LYT-100
(deupirfenidone) for the treatment of idiopathic pulmonary fibrosis
(IPF) as well as the Company’s research surrounding the experiences
of patients with IPF.
The data to be presented have informed the clinical and
commercial strategies supporting LYT-100 as well as advocacy and
patient engagement work around the management and treatment of
people with IPF. Topline results from the Phase 2b ELEVATE IPF
trial are expected by the end of 2024. A streamlined development
program for LYT-100 is planned using the same endpoints that have
supported past IPF product approvals. Pending positive clinical
outcomes from the Phase 2b trial and regulatory feedback, the
program is expected to advance into a Phase 3 trial. PureTech
believes the results of the Phase 2b trial, together with a
successful Phase 3 trial, could serve as the basis for registration
in the U.S. and other geographies.
Presentation Details
Presentation Title: Comparing experiences at interstitial
lung disease (ILD) centers and community practices (CP) from the
perspective of people with idiopathic pulmonary fibrosis (IPF)
Session: Oral presentation Date and Time: October 8,
2024 | 10:20-11:05am EDT
Presentation Title: Ongoing burden of idiopathic
pulmonary fibrosis (IPF) in the era of antifibrotics
Session: Poster presentation Date and Time: October
8, 2024 | 1:45-2:30pm EDT
Presentation Title: Bayesian approach for ELEVATE IPF:
Randomized, double-blind, placebo-controlled trial to evaluate
efficacy, safety, and dose response of deupirfenidone (LYT-100) in
IPF Session: Oral presentation Date and Time: October
8, 2024 | 1:45-2:30pm EDT
About Idiopathic Pulmonary Fibrosis (IPF)
IPF is a rare, progressive and fatal lung disease with a median
survival of 2-5 years.1 Pirfenidone is one of only two drugs
approved to treat IPF, and for those patients able to tolerate
treatment, it has been shown to improve survival by approximately
2.5 years compared to supportive care alone.1 However, tolerability
issues with both of the standard-of-care drugs result in patients
discontinuing treatment or reducing their dose. This contributes to
nearly three out of every four people with IPF choosing to forego
treatment with these otherwise efficacious medicines.2
About LYT-100 (Deupirfenidone)
LYT-100 (deupirfenidone) is being advanced for the treatment of
conditions involving inflammation and fibrosis, including 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 PK profile. LYT-100 has
also demonstrated favorable tolerability 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
pirfenidone-equivalent 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. Topline data for the global Phase 2
ELEVATE IPF trial are expected by the end of 2024.
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 29 therapeutics and therapeutic candidates,
including three that have been approved by the U.S. Food and Drug
Administration. 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 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
without limitation those related to the LYT-100 development program
and development plans, its potential benefits to patients, the
timing for results from the Phase 2b clinical trial of LYT-100, the
advancement of the program into a Phase 3 trial, 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, 2023, 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 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
2 Dempsey TM, Payne S, Sangaralingham L, Yao X, Shah ND, Limper
AH. Adoption of the Antifibrotic Medications Pirfenidone and
Nintedanib for Patients with Idiopathic Pulmonary Fibrosis. Ann Am
Thorac Soc. 2021 Jul;18(7):1121-1128
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PureTech Public Relations
publicrelations@puretechhealth.com Investor Relations UK/EU
Media Ben Atwell, Rob Winder +44 (0) 20 3727 1000
puretech@fticonsulting.com US Media Nichole Bobbyn +1 774
278 8273 nichole@tenbridgecommunications.com
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