RCS - PureTech Health PLC - PRTC Publishes Phase 2b Deupirfenidone IPF Results

Puretech HealthAnnouncement

Yesterday 13:15

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20260402:nRSB1659Za&default-theme=true

RNS Number : 1659Z  PureTech Health PLC  02 April 2026

2 April 2026

PureTech Health plc

 

PureTech Announces Publication of Phase 2b ELEVATE IPF Trial Results in The
American Journal of Respiratory and Critical Care Medicine

Deupirfenidone 825 mg TID monotherapy significantly slowed lung function
decline versus placebo at 26 weeks in people with idiopathic pulmonary
fibrosis (adjusted mean FVC difference 91 mL; p=0.02), approaching the lung
function change expected in normal, healthy aging

First industry-sponsored IPF trial to include a current standard-of-care
treatment as an active comparator in addition to a placebo arm, strengthening
interpretation of efficacy and safety findings

PureTech's Founded Entity, Celea Therapeutics, is working to complete a
financing to enable the initiation of the Phase 3 SURPASS-IPF trial in the
first half of 2026

PureTech Health plc (https://puretechhealth.com/)  (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 publication of results from the Phase 2b ELEVATE IPF trial
of deupirfenidone for the potential treatment of idiopathic pulmonary fibrosis
(IPF) in The American Journal of Respiratory and Critical Care Medicine
(https://doi.org/10.1093/ajrccm/aamag155) (AJRCCM). The results from this
trial informed the design of the upcoming Phase 3 SURPASS-IPF trial, which
will evaluate deupirfenidone 825 mg three times a day (TID) monotherapy as
compared to pirfenidone 801 mg TID monotherapy, in a head-to-head study
powered to test for superiority. PureTech's Founded Entity, Celea
Therapeutics, is working to complete a financing to enable the initiation of
the Phase 3 SURPASS-IPF trial in the first half of 2026.

"The ELEVATE IPF trial provides a rare opportunity to evaluate an
investigational therapy for IPF directly alongside a current standard-of-care
treatment within a randomized controlled trial," said Toby Maher, MD, PhD,
Professor of Medicine and Director of Interstitial Lung Disease at Keck
School of Medicine, University of Southern California, Los Angeles, and
lead author of the study. "The inclusion of pirfenidone as an active
comparator provides important clinical context for interpreting the efficacy
and safety findings and increases confidence as this program moves forward
into a head-to-head Phase 3 superiority trial. More broadly, the magnitude of
the treatment effect demonstrated in this trial suggests that it may be
possible to achieve greater preservation of lung function than has
historically been observed with currently available therapies. If confirmed at
Phase 3, this would have a major impact on our approach to treating patients
with IPF."

Highlights from the publication have been presented in various scientific
forums throughout the course of 2025 and include:

·    Primary and key secondary endpoints achieved: Deupirfenidone
demonstrated a 98.5% and 99.6% posterior probability of superiority vs.
placebo in slowing forced vital capacity (FVC) and forced vital capacity
percent predicted (FVCpp) decline, respectively, at 26 weeks based on the
prespecified Bayesian analysis.

·    Statistically significant and clinically meaningful preservation of
lung function: Deupirfenidone 825 mg TID as a monotherapy significantly slowed
lung function decline versus placebo at 26 weeks as measured by mean FVC
(adjusted difference 91 mL; p=0.02). A secondary analysis of FVCpp also showed
a statistically significant benefit (p=0.01).

·    Lung function decline approached the range expected with healthy
aging: In the deupirfenidone 825 mg TID arm, the rate of FVC decline over 26
weeks (-21.5 mL) approached the normal physiological decline expected in
healthy older adults (approximately -15.0 mL to -25.0 mL). 1  (#_ftn1) (,  2 
(#_ftn2) ) Although not included in the publication, data from the ongoing
Phase 2b ELEVATE IPF open-label extension
(https://news.puretechhealth.com/news-releases/news-release-details/puretechs-deupirfenidone-lyt-100-demonstrates-strong-and-durable)
show that this treatment effect was maintained out to at least 52 weeks, with
participants experiencing a decline in FVC of -32.8 mL. 3  (#_ftn3) This is
also 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)

·    Delay in disease progression: Time to IPF progression, defined as an
absolute decline in FVCpp of ≥5% or death through 26 weeks, was
significantly delayed in patients receiving deupirfenidone 825 mg TID compared
with placebo (HR 0.439; p=0.0023).

·    Greater drug exposure without sacrificing tolerability:
Pharmacokinetic data show that deupirfenidone 825 mg TID results in an
approximately 50% greater drug exposure compared to pirfenidone 801 mg TID
(the highest FDA-approved dose). Importantly, the overall incidence of adverse
events (AEs) with deupirfenidone 825 mg TID was similar to that of pirfenidone
801 mg TID (85.9% vs. 84.1%, respectively), and AEs were generally mild to
moderate. The percentage of patients who remained on deupirfenidone 825 mg TID
for 26 weeks (78.1%) was similar to the percentage of patients remaining on
placebo (80.0%). Taken together, these data suggest that the higher exposure
and improved efficacy observed with deupirfenidone 825 mg TID were achieved
without sacrificing tolerability.

"Publication in AJRCCM validates the rigor of our Phase 2b trial design and
execution and highlights the potential for deupirfenidone to set a new
benchmark in the treatment of IPF," said Sven Dethlefs, PhD, Chief Executive
Officer of Celea Therapeutics. "This trial provides a strong scientific and
clinical foundation as we prepare to advance deupirfenidone into the Phase 3
SURPASS-IPF trial, with the goal of building on these results to deliver a
next-generation antifibrotic that meaningfully improves outcomes for people
living with IPF."

 

About the Phase 2b ELEVATE IPF Trial

The Phase 2b ELEVATE IPF trial was a global, randomized, double-blind, active-
and placebo-controlled, dose-ranging trial designed to evaluate the efficacy,
tolerability, safety, and dosing regimen of deupirfenidone (LYT-100) in
patients with IPF compared to placebo. 257 participants were randomized in a
ratio of 1:1:1:1 to receive either 550 mg of deupirfenidone, 825 mg of
deupirfenidone, 801 mg of pirfenidone or placebo three times a day (TID) for
26 weeks. Participants who completed the trial had the option to enroll in an
open-label extension, which is ongoing.

The primary endpoint of the trial was the rate of decline in Forced Vital
Capacity (FVC) for the combined deupirfenidone arms versus placebo over the
26-week treatment period. FVC is a measure of the maximum amount of air (in
mL) that an individual can forcibly exhale after fully inhaling. It is a
standard measurement in clinical trials for IPF and is used to assess disease
progression as well as to predict mortality.

A prespecified Bayesian analysis was utilized to assess the primary endpoint
and provided a posterior probability, which is the probability of superior
efficacy for deupirfenidone compared to placebo. This also allowed for
augmentation of the placebo arm with placebo data from historical IPF trials.
This approach enabled a more patient-centric clinical trial design by
minimizing the number of trial participants exposed to placebo - a key
consideration since IPF is progressive and fatal - while delivering a robust,
placebo-controlled dataset.

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 of 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 of 2019. 4  (#_ftn4)

 

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, 5  (#_ftn5) and currently there is no cure.

 

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 and is currently a wholly-owned subsidiary of 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.

 

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
LinkedIn (https://www.linkedin.com/company/puretech-health/) and 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 deupirfenidone (LYT-100)
development program and development plans, its potential benefits to patients,
plans for discussions with regulatory authorities, the further development of
the program, future presentation of additional data from the 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, 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.

 

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)

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

 1  (#_ftnref1) FVC decline at 6 months was estimated assuming linear decline
over time.

 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) 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.

 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) 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)

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAEAFLAEADKEEA



            Copyright 2019 Regulatory News Service, all rights reserved