RCS - PureTech Health PLC - PRTC To Present Ph2b IPF Results at ATS Conference

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RNS Number : 9595G  PureTech Health PLC  01 May 2025

1 May 2025

PureTech Health plc

 

PureTech to Present Results from Phase 2b ELEVATE IPF Trial of Deupirfenidone
(LYT-100) at the American Thoracic Society International Conference

 

Late-breaking oral presentation to highlight further evidence supporting
potential for deupirfenidone to serve as a new standard of care for the
treatment of idiopathic pulmonary fibrosis (IPF)

 

Regulatory and strategic planning underway to advance deupirfenidone into
Phase 3 development

 

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 the Company will deliver a late-breaking oral presentation at
the upcoming American Thoracic Society (ATS) International Conference, taking
place in San Francisco, California, from May 16-21, 2025.

 

The presentation will highlight data from the recently completed Phase 2b
ELEVATE IPF trial of deupirfenidone (LYT-100), which demonstrated
(https://news.puretechhealth.com/news-releases/news-release-details/puretechs-deupirfenidone-lyt-100-slowed-lung-function-decline)
unprecedented efficacy outcomes in patients living with idiopathic pulmonary
fibrosis (IPF), including the potential to stabilize lung function decline at
26 weeks while maintaining safety and tolerability.

 

"The Phase 2b ELEVATE IPF trial results represent a major advancement for the
treatment of IPF," said Bharatt Chowrira, Ph.D., J.D., Chief Executive Officer
of PureTech. "Deupirfenidone demonstrated the potential to stabilize lung
function decline over 26 weeks as a monotherapy-something not achieved by
marketed or investigational IPF therapies, to our knowledge. The additional
data we plan to highlight at ATS provide further confidence in the robust and
durable efficacy and favorable tolerability of deupirfenidone. We believe
deupirfenidone has the potential to set a new standard of care and make a
transformative difference for patients living with this devastating disease."

 

PureTech is targeting a meeting with the U.S. Food and Drug Administration by
the end of the third quarter of 2025 to discuss the results of the Phase 2b
trial and align on a potential registrational pathway, with the goal of
initiating a Phase 3 trial by the end of 2025. PureTech anticipates providing
further guidance later this year following the finalization of the trial
design and FDA interactions.

 

Details of the oral presentation are as follows:

 

Title: Deupirfenidone Compared to Placebo and Pirfenidone in Idiopathic
Pulmonary Fibrosis: ELEVATE IPF Phase 2b Trial

 

Presenter: Toby Maher, M.D., Ph.D., Professor of Medicine and Director of
Interstitial Lung Disease at Keck School of Medicine, University of Southern
California

Session: C93 - Advances in interstitial lung disease and pulmonary
hypertension: uncovering novel mechanisms, targeted therapies, and
personalized approaches

Date and Time: May 20, 2025, 2:15 PM Pacific Time

 

About the 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 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 an investigational therapy in development as a
potential new standard of care (SOC) 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. Despite
achieving blockbuster status, the current SOC treatments only modestly slow
lung function decline, with tolerability limiting the ability to achieve
higher doses. This results in suboptimal efficacy, reduced patient uptake, and
poor adherence - all due to a tolerability ceiling that prevents dosing levels
that could significantly improve patient outcomes.

 

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
safety and tolerability - a result not previously achieved by other
investigational or marketed IPF therapies to the Company's knowledge. These
findings support the potential for deupirfenidone to offer a meaningful
advance for patients living with this progressive and life-limiting disease.
Beyond IPF, deupirfenidone may also address multiple underserved fibrotic
diseases, including progressive fibrosing interstitial lung diseases and other
fibrotic conditions.

 

About Idiopathic Pulmonary Fibrosis (IPF)

Idiopathic Pulmonary Fibrosis (IPF) is a rare, progressive and fatal lung
disease characterized by irreversible scarring of lung tissue. Median survival
following diagnosis is estimated to be two to five years. 1  (#_ftn1)  IPF
affects more than 230,000 people across the United States and EU5 (France,
Germany, Italy, Spain, and the United Kingdom). 2  (#_ftn2)

 

Although two therapies are approved to treat IPF, their use remains limited,
and nearly three out of four people with IPF in the United States have never
received either treatment. 3  (#_ftn3) There remains a significant need for
therapies that can more effectively slow or stabilize disease progression,
while maintaining favorable tolerability, to improve outcomes for people
living with IPF.

 

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 portfolio 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 29 therapeutics and therapeutic candidates,
including three that have been approved by the U.S. Food and Drug
Administration. 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 portfolio 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 deupirfenidone development
program and development plans, and 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

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

+1 609 578 7230

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

 

 

 1  (#_ftnref1) 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

 2  (#_ftnref2) GlobalData Epidemiology and Market Size Search, EU5=United
Kingdom, France, Germany, Italy and Spain

 3  (#_ftnref3) Dempsey TM, Payne S, Sangaralingham L, Yao X, Shah ND, Limper
AH. Adoption of the Antifibrotic Medications Pirfenidone and Nintedanib for
Patients with Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2021
Jul;18(7):1121-1128

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