TIDMPRTC
PureTech Health PLC
30 June 2022
30 June 2022
PureTech Health plc
PureTech Initiates Late-Stage Clinical Study of Wholly-Owned
Candidate LYT-100 (Deupirfenidone) in IPF and Advances LYT-200
(Anti-Galectin-9 mAb)
IPF study will evaluate efficacy of two doses of LYT-100, one
with comparable exposure to FDA-approved dose of pirfenidone and
one with higher exposure, vs. placebo, as well as relative
tolerability and efficacy vs. pirfenidone
Bi-monthly, monotherapy dose escalation portion of Phase 1/2
study of LYT-200 for the potential treatment of solid tumors has
completed; evaluation of weekly doses of LYT-200 as a monotherapy
has begun, and combination cohorts with chemotherapy or an
anti-PD-1 to begin later this year
Company also plans to initiate studies with LYT-200 in leukemia
by end of 2022
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company dedicated to
discovering, developing and commercializing highly differentiated
medicines for devastating diseases, today announced the initiation
of a clinical study of LYT-100 (deupirfenidone), PureTech's
wholly-owned therapeutic candidate for the potential treatment of
idiopathic pulmonary fibrosis (IPF), to support its
registration-enabling package. LYT-100 is a selectively deuterated
form of pirfenidone. Pirfenidone is a proven therapy for IPF, a
devastating condition where the favorable tolerability, safety and
potentially higher exposure of LYT-100 could have an important
impact on patient adherence and outcomes.
"The initiation of this study is supported by substantial
clinical data demonstrating favorable safety and tolerability of
LYT-100," said Julie Krop, M.D., Chief Medical Officer of PureTech.
"The unique profile of LYT-100, coupled with the established
efficacy of pirfenidone, has the potential to significantly improve
care for these patients. We believe that enabling patients to stay
on a therapeutic dose longer - even at a dose with comparable
exposure to the FDA-approved dose of pirfenidone - has the
potential to drive better efficacy. In addition, achieving higher
exposure levels than the FDA-approved dose of pirfenidone has the
potential to offer even better efficacy, which is our rationale for
pursuing a higher dose of LYT-100 in this study. We are excited to
be taking this important step towards our goal of helping patients
with this devastating condition."
IPF is a chronic orphan condition that causes progressive
scarring of the lungs, and approximately 130,000 people in the U.S.
are living with the disease. The prognosis of IPF is poor, with the
median survival after diagnosis generally estimated at two to five
years. Pirfenidone is approved by the U.S. Food and Drug
Administration (FDA) for IPF, yet there are serious limitations to
pirfenidone's clinical use, primarily due to severe
gastrointestinal (GI)-related tolerability issues.(1,2)
"Pirfenidone has proven efficacy to slow the decline in lung
function in patients with IPF. However, many patients with IPF who
start pirfenidone have side effects that cause them to either
discontinue therapy or reduce their dose," said Kevin Flaherty,
M.D., Professor of Internal Medicine at the University of Michigan
specializing in IPF and other interstitial lung diseases and an
advisor to PureTech. "I am excited by the safety and tolerability
data generated to date with LYT-100, particularly the most recent
data demonstrating how well-tolerated it was in a relatively sick,
older patient population with multiple comorbidities, as I believe
it could represent great potential in patients with IPF."
LYT-100 is designed to retain the potent and clinically
validated anti-fibrotic and anti-inflammatory activity of
pirfenidone but has demonstrated a highly differentiated
pharmacokinetic (PK) profile that has translated into improved
tolerability in PureTech's ongoing clinical development program. To
date, LYT-100 has been studied in more than 400 subjects and
demonstrated a favorable safety and tolerability profile. In a
crossover study in healthy older adults with similar median age to
patients with IPF , PureTech showed that approximately 50% fewer
subjects experienced GI-related adverse events (AEs) with LYT-100
compared with pirfenidone (17.4% vs. 34.0%) and substantially fewer
subjects experienced AEs with LYT-100 vs. pirfenidone. PureTech
also recently showed that LYT-100 can be safely dosed with a higher
total drug exposure than the currently approved dose of
pirfenidone, which could translate into improved efficacy over
pirfenidone.
The global, randomized, placebo-controlled registration-enabling
study is designed to evaluate the efficacy, tolerability, safety
and dosing regimen of LYT-100 to help inform the study design for a
potential pivotal study and to assess the relative efficacy of
LYT-100 compared to pirfenidone. A total of approximately 240
patients will be randomized 1:1:1:1 to receive either one of two
dose levels of LYT-100, the FDA-approved dose of pirfenidone, or a
placebo. One of the LYT-100 arms will evaluate 550 mg three times a
day (TID) of LYT-100, which has previously demonstrated the
comparable exposure as the currently approved dose of pirfenidone
(801 mg TID), and the other arm will evaluate an 825 mg TID dose of
LYT-100, which has demonstrated higher exposure than the currently
approved dose of pirfenidone with the potential for improved
efficacy. The primary objective of the study is to demonstrate a
statistically significant and clinically meaningful difference in
the slope of decline in a measure of lung function, Forced Vital
Capacity (FVC), in the LYT-100 treatment arms compared to placebo
over 6 months. The study will also evaluate safety, tolerability
and the slope of FVC decline in the LYT-100 treatment arms compared
to pirfenidone, though this analysis is not powered to demonstrate
strict non-inferiority. FVC is an established measure of pulmonary
function in IPF and has served as the basis for FDA approval of the
currently marketed treatments for IPF. Topline results from the
study are expected by the end of 2023.
Advancement of LYT-200 Clinical Program
PureTech's LYT-200 program is also progressing through clinical
development. Following the completion of the monotherapy dose
escalation portion of the Phase 1 program, PureTech has begun to
evaluate weekly doses of LYT-200 and will soon begin to enroll
patients in cohorts designed to evaluate LYT-200 in combination
with chemotherapy or an anti-PD-1 monoclonal antibody. Results from
the single agent cohorts are expected by the end of 2022, and
results from the combination cohorts are expected in 2023.
LYT-200 is a fully human IgG4 monoclonal antibody (mAb) designed
to inhibit the activity of galectin-9, a key molecule expressed by
tumors and immune cells and shown in preclinical models to suppress
the immune system from recognizing and destroying cancer cells. The
primary objective of the Phase 1 portion of the ongoing adaptive
Phase 1/2 study is to assess the safety and tolerability of
escalating doses of LYT-200 in order to identify an appropriate
dose and dosing interval to carry forward into the Phase 2 portion
of the trial. Six cohorts were treated with escalating, bi-monthly
doses from 0.2-16 mg/kg, and no dose limiting toxicities were
reported to date.
Additionally, compelling preclinical data have been generated
with LYT-200 in leukemia models, which will be submitted for
presentation in a scientific forum. Based on these data, PureTech
plans to initiate a study of LYT-200 as a single agent in leukemia
patients by the end of 2022.
"We are very pleased with the progress of our Phase 1 evaluation
of LYT-200, which has demonstrated favorable safety and
tolerability as a single agent at all doses studied to date without
any dose limiting toxicities," said Aleksandra Filipovic, M.D.,
Ph.D., Head of Oncology at PureTech. "We look forward to the
continued evaluation of this novel therapy as a potential treatment
for metastatic solid tumors as well as the initiation of clinical
studies in leukemia."
About LYT-100
LYT-100 is one of seven therapeutic candidates within PureTech's
Wholly Owned Pipeline. It is a selectively deuterated form of
pirfenidone that is designed to retain the potent and
clinically-validated anti-fibrotic and anti-inflammatory activity
of pirfenidone with a differentiated pharmacokinetic profile that
has translated into favorable tolerability, as supported by data
from multiple human clinical studies. LYT-100 is being advanced for
the potential treatment of conditions involving inflammation and
fibrosis, including idiopathic pulmonary fibrosis and breast
cancer-related, upper limb secondary lymphedema. PureTech is also
exploring the potential evaluation of LYT-100 in other inflammatory
and fibrotic conditions such as myocardial and other organ system
fibrosis based on the strength of existing clinical data around the
use of pirfenidone in these indications.
About LYT-200
LYT-200 is a fully human IgG4 monoclonal antibody targeting a
foundational immunosuppressive protein, galectin-9, for the
potential treatment of solid tumors, including pancreatic ductal
adenocarcinoma, colorectal cancer and cholangiocarcinoma, that are
difficult to treat and have poor survival rates. PureTech has
presented preclinical data demonstrating high expression of
galectin-9 across breast cancer, pancreatic and cholangiocarcinoma
samples and found that the highest levels of galectin-9 correlated
with shorter time to disease relapse and poor survival. These data
suggest that galectin-9 could be significant both as a therapeutic
target for a range of cancers and as a cancer biomarker.
Preclinical animal and patient-derived organoid tumor models also
showed the potential efficacy of LYT-200 and the importance of
galectin-9 as a target. LYT-200 is currently being evaluated in a
Phase 1/2 adaptive design trial.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercializing highly
differentiated medicines for devastating diseases, including
inflammatory, fibrotic and immunological conditions, intractable
cancers, lymphatic and gastrointestinal diseases and neurological
and neuropsychological disorders, among others. The Company has
created a broad and deep pipeline through the expertise of its
experienced research and development team and its extensive network
of scientists, clinicians and industry leaders. This pipeline,
which is being advanced both internally and through PureTech's
Founded Entities, is comprised of 27 therapeutics and therapeutic
candidates, including two that have received both U.S. FDA
clearance and European marketing authorization, as of the date of
PureTech's most recently filed Annual Report and corresponding Form
6-K. 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 based on unique insights in immunology and drug
development.
For more information, visit www.puretechhealth.com or connect
with us on 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
those related to our study of LYT-100 for the treatment of IPF and
the timing for topline results from the study, the treatment
potential of LYT-100 for patients with IPF, our LYT-200 development
program and the timing of results for the Phase 1 portion of our
Phase 1/2 study as well as our plans to initiate a study of LYT-200
as a single agent in leukemia patients, and our therapeutic
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, 2021 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.
(1) Rubino, C. M., Bhavnani, S. M., Ambrose, P. G., Forrest, A.,
& Loutit, J. S. (2009). Effect of food and antacids on the
pharmacokinetics of pirfenidone in older healthy adults. Pulmonary
pharmacology & therapeutics, 22(4), 279-285.
https://doi.org/10.1016/j.pupt.2009.03.003
(2) Belhassen, M., Dalon, F., Nolin, M., & Van Ganse, E.
(2021). Comparative outcomes in patients receiving pirfenidone or
nintedanib for idiopathic pulmonary fibrosis. Respiratory research,
22(1), 135. https://doi.org/10.1186/s12931-021-01714-y
Contact:
PureTech
Public Relations
publicrelations@puretechhealth.com
Investor Relations
IR@puretechhealth.com
EU Media
Ben Atwell, Rob Winder
+44 (0) 20 3727 1000
ben.atwell@FTIconsulting.com
U.S. Media
Nichole Sarkis
+1 774 278 8273
nichole@tenbridgecommunications.com
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