RCS - PureTech Health PLC - PRTC LYT-100 Ph2b in IPF Enrolled; Results Q4 2024

Puretech HealthAnnouncement

16/04/2024 12:00

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RNS Number : 7281K  PureTech Health PLC  16 April 2024

16 April 2024

PureTech Health plc

 

PureTech Announces Completion of Enrollment in Phase 2b ELEVATE IPF Trial of
LYT-100 (Deupirfenidone) in Idiopathic Pulmonary Fibrosis

 

Topline results are expected in Q4 2024

 

PureTech Health plc (https://puretechhealth.com/)  (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
(https://news.puretechhealth.com/news-releases/news-release-details/puretech-presents-data-lyt-100-deupirfenidone-trial-healthy)
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.

 

Contact:

PureTech

Public Relations

publicrelations@puretechhealth.com (mailto:publicrelations@puretechhealth.com)

Investor Relations

IR@puretechhealth.com (mailto:IR@puretechhealth.com)

 

UK/EU Media

Ben Atwell, Rob Winder

+44 (0) 20 3727 1000

puretech@fticonsulting.com (mailto:puretech@fticonsulting.com)

 

U.S. Media

Nichole Bobbyn

+1 774 278 8273

nichole@tenbridgecommunications.com
(mailto:nichole@tenbridgecommunications.com)

 

 

 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
(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
(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
(https://doi.org/10.18553/jmcp.2017.23.3-b.s17)

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