RCS - PureTech Health PLC - PRTC: Successful FDA Meeting; IPF Phase 3 in 1H26

Puretech HealthAnnouncement

Mon 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20251208:nRSH6178Ka&default-theme=true

RNS Number : 6178K  PureTech Health PLC  08 December 2025

8 December 2025

PureTech Health plc

 

PureTech Announces Successful End-of-Phase 2 Meeting with FDA for
Deupirfenidone (LYT-100) in Idiopathic Pulmonary Fibrosis

 

Feedback from U.S. Food and Drug Administration (FDA) supports advancement
into a pivotal Phase 3 trial and a 505(b)(2) regulatory pathway

 

Phase 3 SURPASS-IPF trial remains on track to be initiated by PureTech's
Founded Entity, Celea Therapeutics, in the first half of 2026

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 successful
completion of the End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug
Administration (FDA) regarding the development of deupirfenidone (LYT-100) for
the treatment of idiopathic pulmonary fibrosis (IPF). Deupirfenidone is being
advanced by Celea Therapeutics, a Founded Entity established by PureTech to
lead its late-stage development and potential commercialization.

 

"Our discussion with the FDA was productive and provided helpful feedback on
key elements of our Phase 3 program and the overall data expectations for
registration," said Sven Dethlefs, Ph.D., Chief Executive Officer of Celea
Therapeutics. "The forthcoming Phase 3 SURPASS-IPF trial builds on the strong
foundation established by the Phase 2b ELEVATE IPF trial, which demonstrated
deupirfenidone's robust and durable treatment effect as a monotherapy and its
potential to become a new standard of care. In shaping the Phase 3 design, we
incorporated learnings from recent IPF trials and collaborated closely with
patients and clinicians to reflect the latest thinking in the field. We are
now advancing this pivotal program with urgency to bring forward a therapy
with the potential to stabilize lung function and meaningfully improve care
for people with IPF."

 

The pivotal Phase 3 SURPASS-IPF trial will be a global, randomized,
double-blind, head-to-head trial comparing deupirfenidone 825 mg three
times-a-day (TID) to pirfenidone 801 mg TID in adults with IPF who are not on
background therapy. The primary efficacy endpoint is the change from baseline
in absolute forced vital capacity (FVC) at week 52, which will assess the
superiority of deupirfenidone compared with pirfenidone. The 52-week trial
will use the same active comparator and dosing regimen as the Phase 2b
ELEVATE-IPF trial, providing continuity and confidence that the favorable
safety profile and strong treatment effect observed previously can be
replicated and confirmed in a larger, global population. Based on feedback
from the FDA, PureTech believes that the results from this single Phase 3
trial, if successful, and supported by the totality of data from the overall
deupirfenidone development program, could complete the data package required
to support potential registration of deupirfenidone via a streamlined
505(b)(2) pathway.

 

The EOP2 meeting was supported by results from the global Phase 2b randomized,
double-blind, active- and placebo-controlled, dose-ranging ELEVATE IPF trial.
In that trial, 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 open-label extension.
Those who continued treatment with deupirfenidone 825 mg TID maintained a
robust treatment effect and experienced an overall FVC decline of -32.8 mL
over a 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)

PureTech's Founded Entity, Celea Therapeutics, expects to finalize financing
in early 2026 to support the initiation of the Phase 3 SURPASS-IPF trial in
the first half of 2026.

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 of 2019. 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 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 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) 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)

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  NRAUPGCAPUPAPUM



            Copyright 2019 Regulatory News Service, all rights reserved