RCS - PureTech Health PLC - New LYT-100 Data from Phase 1 Trials at Conference

Puretech HealthAnnouncement

11/10/2023 12:00

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RNS Number : 6939P  PureTech Health PLC  11 October 2023

October 11, 2023

 

PureTech Health plc

 

PureTech Presents Data from LYT-100 (Deupirfenidone) Trial in Healthy Older
Adults at CHEST Annual Meeting

 

LYT-100 demonstrated ~50% improvement versus pirfenidone in key adverse events
at a comparable exposure level, which may lead to better patient compliance
and improved treatment outcomes in IPF

 

LYT-100 also demonstrated favorable tolerability at a 43% higher exposure
level, supporting the exploration of a higher dose for potentially enhanced
efficacy in IPF

 

Results informed dose selection for ongoing, global Phase 2b ELEVATE IPF
trial, with topline data expected in 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 clinical data supporting the differentiated profile of LYT-100
(deupirfenidone) at the CHEST Annual Meeting in Honolulu, Hawaii.

 

The presentation expands on data from a completed trial
(https://news.puretechhealth.com/news-releases/news-release-details/puretechs-lyt-100-deupirfenidone-achieves-50-reduction-healthy)
of LYT-100 in healthy older adults, which informed the two doses selected for
the ongoing, global Phase 2b dose-ranging trial of LYT-100 (ELEVATE IPF) in
patients with idiopathic pulmonary fibrosis (IPF). In addition to supporting
the improved tolerability of LYT-100 versus the FDA-approved dose of
pirfenidone, the data provide insights into the selection of the higher dose
of LYT-100 that is also being evaluated in ELEVATE IPF.

 

The trial showed that a 550 mg dose of LYT-100 given three times daily (TID)
provided bioequivalent drug exposure to the FDA-approved dose of pirfenidone,
801 mg TID. LYT-100 also demonstrated a 24% lower peak drug concentration than
pirfenidone, which is a key factor generally associated with tolerability. As
previously announced, this dose also achieved an approximately 50% reduction
in participants experiencing gastro-intestinal (GI) and central nervous system
(CNS)-related adverse events (AEs) compared to those taking pirfenidone.

 

Additionally, the data showed that a higher dose of LYT-100 (824 mg TID),
which achieved a 43% higher exposure level, was well-tolerated with no
additional incidence of GI or CNS AEs when titrated up from LYT-100 550 mg TID
in this trial, supporting the potential to provide enhanced efficacy with
favorable tolerability in IPF. This hypothesis is supported by Phase 3 data
with pirfenidone that showed a dose-response effect on forced vital capacity
and survival in people with IPF. 1  (#_ftn1) PureTech is therefore
investigating the efficacy and tolerability of LYT-100 at 550 mg TID and 825
mg TID in the Phase 2b ELEVATE IPF trial.

 

"These data highlight the potential for LYT-100 to improve both the treatment
experience for people with IPF and - most importantly - enable them to stay on
treatment longer and at an efficacious dose, which should improve their
clinical outcomes," said Julie Krop, M.D., Chief Medical Officer of PureTech
Health. "Our goal with the ELEVATE IPF trial is to validate the ability of
LYT-100 to deliver a more tolerable treatment with equivalent efficacy to
pirfenidone at one dose while also exploring the potential for enhanced
efficacy at a higher dose."

 

"Tolerability is a major challenge with the currently available IPF
treatments, and it often results in both temporary and permanent dose
reductions, premature discontinuation and a reluctance for patients to even
begin treatment," said Dr. Toby Maher, M.D., Ph.D., Professor of Medicine and
Director of Interstitial Lung Disease at Keck School of Medicine, University
of Southern California, Los Angeles, who is presenting the poster at CHEST and
is an investigator in the ELEVATE IPF trial. "The unique profile of
deupirfenidone may offer not only improved tolerability, but it also provides
us with the opportunity to assess whether a higher dose is associated with
improved efficacy - a strategy that has not been possible to test with
pirfenidone due to its poor tolerability. This may benefit both patients
currently taking standard-of-care antifibrotic drugs as well as the 75% of
people with IPF in the US who are not on treatment. The IPF treatment
landscape is in desperate need of new therapeutic approaches that can be used
either as monotherapies or as the backbone for combination therapy, and I look
forward to the results of the ELEVATE IPF trial."

 

About Idiopathic Pulmonary Fibrosis (IPF)

Idiopathic pulmonary fibrosis (IPF) is a rare, progressive and fatal lung
disease with a median survival of 2-5 years. 2  (#_ftn2) Pirfenidone is one of
only two drugs approved to treat IPF, and it has been shown to improve
survival by approximately three years compared to supportive care alone.(2)
However, tolerability issues with both of the standard-of-care drugs result in
patients discontinuing treatment or reducing their dose. As a result, nearly
three out of every four people with IPF forego treatment with these otherwise
efficacious medicines. 3  (#_ftn3)

 

About LYT-100 (Deupirfenidone)

LYT-100 (deupirfenidone) is being advanced for the treatment of conditions
involving inflammation and fibrosis, including idiopathic pulmonary fibrosis
(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 pharmacokinetic (PK) profile. This PK profile has
translated into favorable tolerability as demonstrated 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 the same or higher 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.

 

For more information on the global, Phase 2b ELEVATE IPF trial,
visit clinicaltrials.gov
(https://clinicaltrials.gov/ct2/show/NCT05321420?cond=NCT05321420&draw=2&rank=1)
 (NCT05321420). Those in the United States may also visit ELEVATEIPF.com
(https://elevateipf.com/studies/elevate-ipf?locale=en&utm_source=direct) .

 

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 27 therapeutics and therapeutic candidates,
including two (Plenity® and EndeavorRx®) that have received both US
FDA clearance and European marketing authorization and a third (KarXT) that
has been filed for FDA approval. 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 known as
Twitter, @puretechh (https://twitter.com/PureTechH) .

 

Cautionary Note Regarding Forward-Looking Statements

This press release contains 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
statements that relate to our hypotheses and expectations around the treatment
potential associated with LYT-100, including potential tolerability and
efficacy benefits as compared to the current standard of care for IPF
patients, our product candidates and approach towards addressing major
diseases, 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,
2022 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)

 EU Media

 Ben Atwell, Rob Winder

 +44 (0) 20 3727 1000

 ben.atwell@FTIconsulting.com (mailto:ben.atwell@FTIconsulting.com)

 U.S. Media

 Nichole Sarkis

 +1 774 278 8273

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

 

 

 

 1  (#_ftnref1) King, T. E., Bradford, W. Z., Castro-Bernardini, S., Fagan, E.
A., Glaspole, I., Glassberg, M. K., Gorina, E., Hopkins, P., Kardatzke, D.,
Lancaster, L., Lederer, D. J., Nathan, S. D., De Castro Pereira, C. A., Sahn,
S. A., Sussman, R., Swigris, J. J., & Noble, P. W. (2014). A Phase 3 Trial
of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The New
England Journal of Medicine, 370(22),
2083-2092. https://doi.org/10.1056/nejmoa1402582

 2  (#_ftnref2) 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

 3  (#_ftnref3) Dempsey, T., Payne, S. C., Sangaralingham, L. R., Yao, X.,
Shah, N., & 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.
https://doi.org/10.1513/annalsats.202007-901oc

 

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