Topline results are expected in Q4 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 that enrollment has been completed in the ELEVATE IPF
Phase 2b clinical trial evaluating LYT-100 (deupirfenidone) in
patients with idiopathic pulmonary fibrosis (IPF).
LYT-100 is a deuterated form of pirfenidone, which is one of the
two standard-of-care treatments, along with nintedanib, approved to
treat IPF. Both pirfenidone and nintedanib are efficacious but
associated with significant tolerability issues, contributing to
approximately 75 percent of people with IPF in the U.S. choosing to
forego treatment.1 LYT-100 is designed to address this unmet need
by retaining the beneficial pharmacology and clinically-validated
efficacy of pirfenidone with a highly differentiated
pharmacokinetic (PK) profile. This PK profile and the resulting
favorable tolerability have been demonstrated across multiple
clinical trials in more than 400 individuals.
“Despite the severity and progressive nature of IPF, there has
been a dearth of successful therapeutic innovation since the
approvals of pirfenidone and nintedanib nearly a decade ago,” said
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, and an investigator in the
ELEVATE IPF trial. “LYT-100 builds on the established efficacy of
pirfenidone, and data generated to date suggest it may address key
tolerability issues that prevent patients from starting or
continuing treatment. LYT-100 has the potential to have a profound
impact on the way IPF is managed by allowing patients to start,
continue and fully benefit from treatment, both as monotherapy and
in combination settings with other antifibrotic therapies. This
milestone in the ELEVATE IPF trial is very exciting, and I look
forward to the full results as a potential step forward for the
large, underserved IPF patient community.”
The Phase 2b ELEVATE IPF trial is a randomized, double-blind,
placebo-controlled, dose-finding study designed to evaluate the
efficacy, tolerability, safety and dosing regimen of LYT-100 in
patients with IPF compared to placebo. The trial will also assess
the relative efficacy of two doses of LYT-100. Participants have
been randomized in a ratio of 1:1:1:1 to receive either 550 mg of
LYT-100, 825 mg of LYT-100, pirfenidone or placebo three times a
day (TID) for up to 26 weeks and includes an optional open-label
extension. The primary endpoint is the rate of decline in Forced
Vital Capacity (FVC) for the combined LYT-100 arms versus placebo
over the 26-week treatment period using a prespecified Bayesian
approach. Other key endpoints include tolerability measures,
biomarkers and patient-reported outcomes. Both doses of LYT-100
will be compared to pirfenidone, though the trial is not powered to
show a statistical difference in efficacy between LYT-100 and
pirfenidone. Topline results are expected in the fourth quarter of
2024.
PureTech has previously shared data from a crossover trial
showing that a 550 mg dose of LYT-100 provided bioequivalent drug
exposure to the FDA-approved dose of pirfenidone, 801 mg. This dose
also achieved an approximately 50 percent 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 percent higher drug
exposure level, was well-tolerated with no additional incidence of
GI or CNS AEs when titrated up from LYT-100 550 mg TID. These
results reinforce the potential for LYT-100 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.2 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.
PureTech plans to pursue a streamlined development program for
LYT-100 in IPF and is using the same validated endpoints that have
supported past antifibrotic approvals. PureTech believes the
results of the Phase 2b trial, together with an additional Phase 3
trial, could serve as the basis for registration in the U.S. and
other geographies.
PureTech would like to extend its gratitude to those
participating in the ELEVATE IPF trial, especially the people
living with IPF and their caregivers, the clinical trial sites,
investigators and advocacy groups.
About Idiopathic Pulmonary Fibrosis (IPF) IPF is a rare,
progressive and fatal lung disease with a median survival of 2-5
years.3 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.3 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.1
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. 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
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.
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 28
therapeutics and therapeutic candidates, including two that have
received both U.S. 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 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 and the timing for results from ongoing
clinical trials of LYT-100, 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 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 2 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
3 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
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