RCS - PureTech Health PLC - PRTC's IPF Patient Research & Ph 2b On Track YE24

Puretech HealthAnnouncement

09/10/2024 07:00

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RNS Number : 4612H  PureTech Health PLC  09 October 2024

9 October 2024

PureTech Health plc

 

PureTech Presents Research Highlighting Burden of Idiopathic Pulmonary
Fibrosis (IPF) and Use of a Bayesian Statistical Analysis for LYT-100
(Deupirfenidone) at CHEST 2024 Annual Meeting

 

IPF patient survey provides new insights into disease burden and patient
experience one decade after the approval of the first antifibrotics for IPF

 

Clinical abstract reviews the ability of Bayesian analysis to maximize
statistical power and reduce the number of patients on placebo in Phase 2b
ELEVATE IPF trial of LYT-100

 

Topline data from the Phase 2b ELEVATE IPF trial of LYT-100 expected by the
end of 2024

 

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,
presented two oral presentations and one poster supporting its clinical and
patient engagement strategies related to LYT-100 (deupirfenidone) for the
treatment of idiopathic pulmonary fibrosis (IPF) at the CHEST 2024 Annual
Meeting in Boston, Massachusetts.

 

"This month marks a decade since the first two antifibrotics for the treatment
of IPF were approved, and since then, limited therapeutic advances have been
made and people with IPF still face substantial challenges," said Camilla
Graham, MD, MPH, Vice President of Medical Affairs at PureTech Health. "At
PureTech, we are investing in changing this paradigm and this research
highlights ongoing gaps with symptom management and supportive care in IPF. We
hope this research will help improve communications between people with IPF
and their healthcare teams. It also informs our work to develop a new IPF
treatment option, which we believe will address key limitations of the current
standard-of-care medicines."

 

PureTech presented qualitative and quantitative research that highlights both
the burden of IPF as well as gaps in disease management that exacerbate the
quality of life for people with IPF. The 90-person survey found that the
majority of participants experience a high burden of disease that interferes
with their normal activities, including shortness of breath (86%), fatigue
(78%) and cough (77%). In addition to the burden of the disease itself,
comorbidities, side effects of antifibrotic treatment and the use of
supplemental oxygen interfere with patients' quality of life, suggesting a
need for improved interventions to manage symptoms.

 

Beyond this, PureTech's research revealed commonalities and differences in the
patient experience for those receiving care at interstitial lung disease (ILD)
centers (n=45) versus community pulmonary practices (CPP) (n=45). When asked
about their top resources for IPF information, nearly all people in both care
settings listed their pulmonologist as their primary source, and the majority
in each were very satisfied with their communications about their IPF
diagnosis. Antifibrotic treatment rates at ILD centers and CPPs were similar,
but differences existed in perceived communication around antifibrotic
treatment options. 76% of people receiving care in ILD centers reported that
their pulmonologist had discussed both FDA-approved antifibrotics with them,
while this was only true of 56% of those receiving care at CPPs. Across a
series of quality-of-life parameters, patients at CPPs indicated a higher
impact and severity of their disease than patients at ILD centers, reflecting
an important discrepancy that merits further investigation.

 

PureTech also presented a clinical abstract reviewing its plan to evaluate the
primary outcome of the Phase 2b ELEVATE IPF clinical trial using a
prespecified Bayesian approach. ELEVATE IPF is PureTech's randomized,
double-blind, placebo-controlled, dose-finding study designed to evaluate the
efficacy, tolerability, safety and dosing regimen of LYT-100 in patients with
IPF compared to placebo. The trial will also assess the relative efficacy of
two doses of LYT-100. Participants have been randomized in a ratio of 1:1:1:1
to receive either 550 mg of LYT-100, 825 mg of LYT-100, pirfenidone or placebo
three times a day (TID) for up to 26 weeks and have the option to enroll in an
open-label extension. The primary endpoint is the rate of decline in Forced
Vital Capacity (FVC) for the combined LYT-100 arms versus placebo over the
26-week treatment period using a Bayesian linear mixed effects model including
dynamic borrowing. This approach augments the placebo arm sample size with
external placebo data from historical IPF trials. A Bayesian approach has the
advantage of enhancing overall statistical power and improving decision-making
while limiting the number of patients required to be treated with placebo in a
fatal disease. This approach has been used previously in Phase 2 trials of
novel IPF therapeutics.

 

"Bayesian dynamic borrowing allows us to leverage historical trial data for
the placebo arm to maximize the number of patients exposed to active treatment
arms and minimize the number exposed to placebo," said Carol Ann Satler, MD,
PhD, Senior Director, Clinical Development at PureTech. "IPF is a rare, fatal
disease, underscoring the importance of efficient clinical trial design.
Bayesian analyses have previously been leveraged in IPF studies for this
reason, especially given the substantial historical placebo dataset in IPF,
and we look forward to sharing results from our Phase 2b trial by the end of
this year."

 

Topline results from the Phase 2b ELEVATE IPF trial are expected by the end of
2024. A streamlined development program for LYT-100 is planned using the same
endpoints that have supported past IPF product approvals. Pending positive
clinical outcomes and regulatory feedback, the program will advance into a
Phase 3 clinical trial. PureTech believes the results of the Phase 2b trial,
together with a successful Phase 3 trial, could serve as the basis for
registration in the U.S. and other geographies.

 

About Idiopathic Pulmonary Fibrosis (IPF)

IPF is a rare, progressive and fatal lung disease with a median survival of
2-5 years. 1  (#_ftn1)  Pirfenidone is one of only two drugs approved to
treat IPF, and for those patients able to tolerate treatment, it has been
shown to improve survival by approximately 2.5 years compared to supportive
care alone.(1) However, tolerability issues with both of the standard-of-care
drugs result in patients discontinuing treatment or reducing their dose. This
contributes to nearly three out of every four people with IPF choosing to
forego treatment with these otherwise efficacious medicines. 2  (#_ftn2)

 

About LYT-100 (Deupirfenidone)

LYT-100 (deupirfenidone) is being advanced for the treatment of conditions
involving inflammation and fibrosis, including IPF. It is a deuterated form
of pirfenidone that is designed to retain the beneficial pharmacology and
clinically-validated efficacy of pirfenidone with a highly differentiated PK
profile. LYT-100 has also demonstrated favorable tolerability across multiple
clinical studies in more than 400 individuals.

 

Pirfenidone is one of the two standard-of-care treatments approved for IPF,
along with nintedanib, both of which are efficacious but associated with
significant tolerability issues. These tolerability issues result in treatment
discontinuations and/or dose reductions below the FDA-approved dose, thereby
limiting the effectiveness of these otherwise efficacious medicines. With
LYT-100, PureTech aims to deliver better outcomes for patients by enabling
individuals to maintain comparable or higher pirfenidone-equivalent doses for
longer. PureTech believes LYT-100 has the potential both to supplant the
current standard-of-care treatments and to serve a larger market of patients
who are unable to tolerate current therapies. Topline data for the global
Phase 2 ELEVATE IPF trial are expected by the end of 2024.

 

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 pipeline 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 pipeline 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
(http://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 LYT-100 development program
and development plans, its potential benefits to patients, the timing for
results from the Phase 2b clinical trial of LYT-100, the advancement of the
program into a Phase 3 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, 2023, 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)

 

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:nichole@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
(https://doi.org/10.18553/jmcp.2017.23.3-b.s17)

 2  (#_ftnref2) 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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