RCS - PureTech Health PLC - PRTC: New IPF Data Show Benefit in Older Patients

Puretech HealthAnnouncement

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RNS Number : 2917E  PureTech Health PLC  22 October 2025

22 October 2025

PureTech Health plc

 

PureTech Presents New Phase 2b Analyses Demonstrating Consistent Safety and
Efficacy of Deupirfenidone in Older Patients with Idiopathic Pulmonary
Fibrosis (IPF), a Historically Undertreated Group

 

Data presented at the CHEST 2025 Annual Meeting highlight deupirfenidone's
differentiated profile and potential to address unmet needs across age groups

 

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"),
a hub-and-spoke biotherapeutics company dedicated to giving life to science
and transforming innovation into value, today announced the presentation of
new analyses from the Phase 2b ELEVATE IPF trial of deupirfenidone (LYT-100)
for the treatment of idiopathic pulmonary fibrosis (IPF). The data show that
the favorable safety and efficacy profile of deupirfenidone was consistent
across age groups, including in patients aged 75 years and older. These
findings, presented at the American College of Chest Physicians (CHEST) 2025
Annual Meeting, suggest that deupirfenidone may address a key gap in the
treatment of IPF, as older patients have historically been less likely to be
treated, largely due to tolerability challenges. 1  (#_ftn1) (, 2  (#_ftn2) )
These data further reinforce deupirfenidone's differentiated profile and
support its potential to meaningfully improve care for this vulnerable
population.

 

"These data are a welcome indication that age does not necessarily translate
to a poorer treatment experience in IPF, which is generally a disease of older
people," said Tejaswini Kulkarni, MD, MPH, Associate Professor of Pulmonary,
Allergy and Critical Care Medicine at the University of Alabama at Birmingham,
who presented the data at CHEST 2025. "Older people with IPF have historically
been undertreated and underrepresented in clinical trials because antifibrotic
medications can be especially difficult to tolerate for this demographic.
Demonstrating consistent safety and efficacy, particularly in this population,
reinforces the differentiated profile of deupirfenidone and its potential to
benefit a broad range of patients living with IPF."

 

ELEVATE IPF was a randomized, double-blind, active- and placebo-controlled
Phase 2b trial evaluating deupirfenidone 825 mg TID and deupirfenidone 550 mg
TID compared to placebo and pirfenidone 801 mg TID in patients with IPF. This
sub-analysis primarily focused on safety and tolerability in patients aged
≥75 years (n=91) compared with those aged <75 years (n=166), as
tolerability challenges are a primary barrier to treatment in older
populations. Treatment emergent adverse events, including gastrointestinal
events, were similar for both age groups, indicating that older patients
tolerated deupirfenidone comparably to younger patients. For example, the
rates of nausea in patients aged ≥75 years vs. <75 years were 18.2% vs.
21.4% for deupirfenidone 825 mg TID; 14.3% vs. 18.2% for deupirfenidone 550 mg
TID; 25.9% vs. 27.8% for pirfenidone 801 mg TID; and 9.5% vs. 6.8% for
placebo. Efficacy also remained consistent with previously reported
(https://news.puretechhealth.com/news-releases/news-release-details/puretechs-deupirfenidone-lyt-100-demonstrates-strong-and-durable)
results, providing additional support for deupirfenidone's differentiated
profile in this patient population.

 

"Older patients represent a large and growing segment of the IPF population,
yet they've historically been less likely to receive treatment due to concerns
around tolerability," said Camilla Graham, MD, MPH, Senior Vice President of
Medical Affairs at PureTech. "These findings highlight deupirfenidone's
potential to be an attractive treatment option for a broader range of
patients, including those who have often been underserved, while maintaining
the strong efficacy profile demonstrated in the Phase 2b trial."

 

About Deupirfenidone (LYT-100)

Deupirfenidone (LYT-100) is in development as a potential new standard of care
for the treatment of idiopathic pulmonary fibrosis (IPF). It is a next
generation antifibrotic and a deuterated form of pirfenidone, one of three
FDA-approved therapies for IPF. The uptake and adherence to approved
antifibrotics has historically been limited by a tradeoff between modest
efficacy and tolerability, and only ~25% of people with IPF in the U.S. had
ever received treatment as of2019. 3  (#_ftn3)

 

Deupirfenidone may overcome these limitations. In the global Phase 2b ELEVATE
IPF trial, deupirfenidone demonstrated the potential to stabilize lung
function decline over at least 26 weeks as a monotherapy while maintaining a
favorable safety and tolerability profile. Initial data from an ongoing
open-label extension study suggest this effect may be sustained through at
least 52 weeks. These findings support the potential for deupirfenidone to
offer a meaningful advance for people living with this progressive and deadly
disease. Beyond IPF, deupirfenidone may also address multiple underserved
fibrotic conditions, including progressive fibrosing interstitial lung
diseases.

 

About Idiopathic Pulmonary Fibrosis (IPF)

Idiopathic pulmonary fibrosis (IPF) is a rare, progressive, and fatal lung
disease characterized by irreversible scarring of lung tissue that leads to a
steady decline in lung function. Median survival following diagnosis is
estimated to be two to five years, and currently there is no cure. 4  (#_ftn4)

 

About Celea Therapeutics

Celea Therapeutics is dedicated to advancing transformative treatments for
people with serious respiratory diseases. Drawn from the Latin word for "sky,"
the name reflects the company's mission to rise above the status quo and
deliver therapies that change lives. The company's lead program,
deupirfenidone (LYT-100), is a Phase 3-ready therapeutic candidate with the
potential to set a new standard of care for idiopathic pulmonary fibrosis
(IPF) and other fibrotic lung diseases.

 

Celea was founded by PureTech Health plc (Nasdaq: PRTC, LSE: PRTC), a
biotherapeutics company dedicated to giving life to science. PureTech's
innovative R&D model drives the creation of Founded Entities like Celea,
enabling the advancement of highly promising medicines to patients in a
capital-efficient manner. For more information, please visit www.celeatx.com
and www.puretechhealth.com.

 

About PureTech Health

PureTech Health is a hub-and-spoke biotherapeutics company dedicated to giving
life to science and transforming innovation into value. We do this through a
proven, capital-efficient R&D model focused on opportunities with
validated pharmacology and untapped potential to address significant patient
needs. This strategy has produced dozens of therapeutic candidates, including
three that have received U.S. FDA approval. By identifying, shaping, and
de-risking these high-conviction assets, and scaling them through dedicated
structures backed by external capital, we accelerate their path to patients
while creating sustainable value for shareholders.

 

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 statements that relate to continued development
of and regulatory interactions related to deupirfenidone, the potential of
deupirfenidone in IPF and other indications, our expectations around our
therapeutic candidates and approach towards addressing major diseases, our
plans to advance our programs and deliver on our milestones, our future plans,
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, 2024 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.

 

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)

US Media
Justin Chen
jchen@tenbridgecommunications.com (mailto:jchen@tenbridgecommunications.com)

 

 

 1  (#_ftnref1) Qiu, Y., Zhu, J., Chopra, P., Elpers, B., Dieyi, C., Byrne,
C., Tang, J., Wang, Y., Govindaraj, K., & Fischer, A. (2024). Real-world
antifibrotic treatment patterns in patients with idiopathic pulmonary
fibrosis: retrospective analyses of two large healthcare administrative
databases in the United States. Therapeutic Advances in Respiratory
Disease, 18. https://doi.org/10.1177/17534666241280704

 2  (#_ftnref2) Cilli, A., Ocal, N., Uzer, F., Coskun, F., Sevinc, C.,
Ursavas, A., Yıldız, P., Deniz, P. P., Demirci, N. Y., Ozbey, G., Yurttas,
A., & Hanta, I. (2023). Elderly idiopathic pulmonary fibrosis patients
remain on therapy despite higher incidence of adverse events and dose
reductions. Respiratory Investigation, 61(4), 490-497.
https://doi.org/10.1016/j.resinv.2023.04.007

 

 3  (#_ftnref3) Dempsey, T. M., Payne, S., Sangaralingham, L., Yao, X., Shah,
N. D., & 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.

 4  (#_ftnref4) 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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