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RNS Number : 0944B  PureTech Health PLC  29 September 2025

29 September 2025

PureTech Health plc

 

PureTech Presents New Data from Phase 2b Open-Label Extension Study of
Deupirfenidone (LYT-100), Further Supporting Strong and Durable Efficacy and
Potential to Serve as New Standard of Care in IPF

 

Patients who switched from placebo or pirfenidone to deupirfenidone in the
open-label extension study achieved stabilization of lung function with
favorable tolerability

 

Findings further substantiate safety and efficacy results from the randomized,
placebo- and active-controlled 26-week trial and highlight opportunity to
address patients inadequately served by current therapies

 

Regulatory engagement underway; update on Phase 3 trial design expected in Q4
2025

 

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 new data from the
open-label extension (OLE) of its Phase 2b ELEVATE IPF trial of deupirfenidone
(LYT-100) in people living with idiopathic pulmonary fibrosis (IPF). These new
results showed that participants who completed 26 weeks of placebo or
pirfenidone treatment in the randomized portion of the trial and then switched
to deupirfenidone for an additional 26 weeks in the OLE achieved stabilization
of lung function. These findings, delivered in a late-breaking oral
presentation at the 2025 European Respiratory Society (ERS) Congress in
Amsterdam, Netherlands, highlight the potential for deupirfenidone to become a
new standard of care for the treatment of IPF.

 

"The blinded portion of the ELEVATE trial challenged the perspective that the
biggest opportunity for new therapies in IPF is improved safety, by showing
that treatment with deupirfenidone 825 mg three times a day can achieve lung
function stabilization with favorable tolerability. The initial 52-week
extension data then raised the bar by demonstrating that this effect with
deupirfenidone was durable," said Argyrios E. Tzouvelekis, M.D., Ph.D.,
University of Patras, Greece, and presenting investigator at ERS 2025. "Now we
are seeing that two additional patient cohorts who experienced lung function
decline in Part A of the trial achieved stabilization once switched to
deupirfenidone. These findings reinforce that the blinded results with
deupirfenidone are reproducible and support the potential for benefit in
patients transitioning from standard of care."

 

ELEVATE IPF, a global, randomized, double-blind, active- and
placebo-controlled Phase 2b trial, achieved its primary endpoint and
demonstrated a statistically significant and clinically meaningful reduction
in lung function decline at 26 weeks with deupirfenidone 825 mg three times a
day (TID) compared to placebo (Part A). As previously announced
(https://news.puretechhealth.com/news-releases/news-release-details/puretechs-deupirfenidone-lyt-100-demonstrates-strong-and-durable)
, participants treated with deupirfenidone 825 mg TID experienced a slower
rate of lung function decline, as measured by change from baseline of Forced
Vital Capacity (FVC), at 26 weeks versus those who were treated with
pirfenidone 801 mg TID or placebo (-21.5 mL vs. -51.6 mL vs. -112.5 mL,
respectively), with a 91 mL difference between deupirfenidone 825 mg and
placebo at 26 weeks. Following the completion of the blinded portion of the
trial, 170 participants (more than 90%) enrolled in the OLE (Part B). Those
who remained on deupirfenidone 825 mg TID maintained a robust treatment effect
and experienced an overall FVC decline of -32.8 mL over the 52-week period, 1 
(#_ftn1) which is similar to the expected natural decline in lung function in
healthy older adults over that time (approximately -30.0 mL to -50.0 mL). 2 
(#_ftn2)

 

The new results presented at ERS provide additional evidence from participants
who initially received placebo or pirfenidone for 26 weeks during Part A and
then switched to deupirfenidone for 26 weeks in Part B. Those who switched
from placebo to deupirfenidone 825 mg TID (n=17) had a mean change in FVC of
+20.0 mL (placebo switch cohort), while those who switched from pirfenidone to
deupirfenidone 825 mg TID (n=16) had a mean change in FVC of -23.1 mL
(pirfenidone switch cohort). 3  (#_ftn3) These results provide further
evidence from two additional patient cohorts that deupirfenidone may stabilize
the decline in lung function to that expected of healthy older adults and
suggest a potential benefit for patients transitioning from standard of care
to deupirfenidone.

 

Deupirfenidone continued to be well tolerated at both doses studied in Part B
after six months of treatment, and the safety profile remained consistent with
Part A. Additional analyses shared at ERS included a summary of the most
common treatment-emergent adverse events (TEAEs) in the OLE, defined as
occurring in at least 10% of participants in either treatment group. As of May
9, 2025, the most common TEAEs were nausea (8.4% vs. 11.5%), dyspepsia (14.5%
vs. 12.6%), upper respiratory infections (16.9% vs. 17.2%), and cough (10.8%
vs. 4.6%) for deupirfenidone 550 mg TID (n=83) and deupirfenidone 825 mg TID
(n=87), respectively.

 

"The ELEVATE trial has been designed and executed to provide one of the most
rigorous Phase 2 evaluations of a potential therapy in IPF," said Sven
Dethlefs, Ph.D., Chief Executive Officer of Celea Therapeutics, the PureTech
Founded Entity created to advance deupirfenidone. "The reproducibility we're
seeing across blinded and extension data, and now in switch cohorts, gives us
strong confidence in the robustness of the findings. We believe deupirfenidone
has the potential to become a new standard of care in IPF, and we are actively
engaging with regulators to finalize the Phase 3 trial design and expect to
share an update in the fourth quarter."

 

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 deuterated
form of pirfenidone, which - along with nintedanib - is one of the two
FDA-approved treatments for IPF.  Both approved therapies offer only modest
efficacy in slowing lung function decline, largely due to tolerability
challenges that limit the ability to achieve higher doses that could
significantly improve patient outcomes. These limitations have contributed to
low treatment uptake and poor adherence, with approximately 25% of people with
IPF in the U.S. ever receiving either drug. 4  (#_ftn4) Despite this, combined
peak global sales exceed $5 billion, representing a significant market
opportunity in IPF and other fibrotic lung diseases.  5  (#_ftn5)

 

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 that 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. 6  (#_ftn6)

 

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) Integrated analysis of double-blind (26 weeks) and initial
open-label extension data from Phase 2b ELEVATE IPF trial as of May 9, 2025,
using a random coefficient regression model with absolute FVC including
baseline as response variable and week, treatment and interaction between week
and treatment as fixed effect. The analysis was performed based on the
predefined Full Analysis Set.

 2  (#_ftnref2) Valenzuela, C., Bonella, F., Moor, C., Weimann, G., Miede, C.,
Stowasser, S., & Maher, T. (2024, September). Decline in forced vital
capacity (FVC) in subjects with idiopathic pulmonary fibrosis (IPF) and
progressive pulmonary fibrosis (PPF) compared with healthy references [Poster
presentation]. European Respiratory Society International Congress, Vienna,
Austria; and Luoto, J., Pihlsgård, M., Wollmer, P., & Elmståhl, S.
(2019). Relative and absolute lung function change in a general population
aged 60-102 years. European Respiratory Journal, 53(3), 1701812.
https://doi.org/10.1183/13993003.01812-2017
(https://doi.org/10.1183/13993003.01812-2017)

 3  (#_ftnref3) Part B analysis is based on switch patients (those who
completed 26 weeks of placebo or pirfenidone in Part A and then were
re-randomized to receive deupirfenidone 825 mg TID in Part B). Patients were
re-baselined to the last available FVC measurement obtained prior to the first
administration of deupirfenidone 825 mg TID in Part B. Observed mean (SE)
values are presented over time as of May 9, 2025.

 4  (#_ftnref4) 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.

 5  (#_ftnref5) Esbriet peak sales (2020) per Roche 2021 Financial Results
& Ofev peak sales (2024) per Boehringer Ingelheim 2024 Financial Results.
Ofev sales include those for all approved indications - IPF, PF-ILD, and
systemic sclerosis-associated interstitial lung disease (SSc-ILD).

 6  (#_ftnref6) 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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