TIDMPRTC
PureTech Health PLC
16 November 2021
16 November 2021
PureTech Health plc
PureTech Announces Publication of Phase 1 Results for LYT-100 in
the Journal Clinical Pharmacology in Drug Development and Provides
Timing Updates
LYT-100 well-tolerated at all doses studied with a favorable PK
profile; maximum tolerated dose not determined; additional studies
underway to evaluate higher doses.
Phase 2 enrollment of LYT-100 in patients with Long COVID(1)
respiratory complications expected to complete by year-end; results
anticipated in 1H 2022.
Phase 1 healthy volunteer trials underway to further evaluate
LYT-100 PK, dosing and tolerability to inform clinical development
of LYT-100 across multiple indications; results anticipated in Q1
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 that the
results from a Phase 1 trial evaluating multiple ascending doses
and the food effect of LYT-100 (deupirfenidone) were published in
the journal Clinical Pharmacology in Drug Development . Topline
results from this Phase 1 study were previously announced in
November 2020 and demonstrated that LYT-100 was well-tolerated in
healthy volunteers under both fed and fasting conditions.
LYT-100 is PureTech's wholly-owned therapeutic candidate that is
being advanced for the potential treatment of conditions involving
inflammation and fibrosis and disorders of lymphatic flow. It is
currently being evaluated in two Phase 2 trials in patients with
Long COVID respiratory complications and breast cancer-related,
upper limb secondary lymphedema. Enrollment in the Long COVID
respiratory trial is expected to be completed by the end of 2021,
with topline results anticipated in the first half of 2022. Topline
results from the breast cancer-related, upper limb secondary
lymphedema trial are anticipated in 2022.
"The data set from the completed Phase 1 MAD study, including a
favorable safety and tolerability profile, reaffirms our belief
that LYT-100 has the potential to be an attractive therapeutic
option across a range of conditions. There are substantial
shortcomings with the current standards of care for patients living
with fibrotic lung disease, and we believe that the anti-fibrotic
and anti-inflammatory properties along with the favorable
tolerability profile demonstrated with LYT-100 to date could
address this issue," said Michael Chen, Ph.D., Head of Innovation
at PureTech Health. "We're encouraged by these results and look
forward to the upcoming clinical readouts as we advance LYT-100 in
multiple indications."
LYT-100 is a selectively deuterated form of pirfenidone that
retains the pharmacologic properties of the parent compound but is
expected to be metabolized at an attenuated rate. GI-related
tolerability issues have historically been associated with
pirfenidone and have limited its usage in patients at the
therapeutic dose approved by the U.S. Food and Drug Administration
(FDA) for the treatment of idiopathic pulmonary fibrosis (IPF).
Despite a noted dose-efficacy response in clinical trials in
patients with IPF, higher doses of pirfenidone have not been
adequately explored due to limitations in tolerability. PureTech is
currently exploring the pharmacokinetic (PK) and tolerability
profile of LYT-100 across a range of doses in order to determine
whether LYT-100 can achieve higher levels of systemic exposure than
the currently FDA-approved dose of pirfenidone.
Multiple ascending dose and food effect study results
The Phase 1 multiple ascending dose and food effect study was a
randomized, double-blind, placebo-controlled study designed to
evaluate the safety, tolerability, PK profile and food effect of
LYT-100 in healthy volunteers in both fed and fasting states.
Plasma concentrations of LYT-100 and its metabolites were measured
to determine PK parameters.
Part 1 assessed multiple ascending doses of LYT-100 administered
in doses of 100 mg, 250 mg, 500 mg, 750 mg and 1000 mg BID over
five days without dose titration. Part 2 assessed the effect of fed
versus fasting conditions on the PK profile of LYT-100 following a
single 500 mg dose. No dose limiting toxicities were noted, and a
maximum tolerated dose was not determined.
All adverse events (AEs) that were possibly or probably related
to LYT-100 were mild. Of the 40 participants, 37 (92.5%) completed
part 1 of the study and eight participants who completed part 1
also completed part 2. The most common AEs across part 1 of the
multiple ascending dose cohorts were headache, abdominal distension
and nausea. There were no tolerability issues after administration
of a single dose of 500 mg given with or without food.
A dose-proportional PK profile was observed with LYT-100
throughout the range of doses studied. As with pirfenidone, LYT-100
exposure was affected by food, with fed conditions resulting in
lower drug exposure compared to fasting conditions. The ratio of
exposure during fed conditions was approximately 20% to 25% less
than exposure during fasting. Fed conditions led to a 26% reduction
in Cmax observed with LYT-100, while the Cmax reduction stated in
the ESBRIET(R) (pirfenidone) U.S. Prescribing Information is
49%.
The therapeutic dose of pirfenidone approved by the FDA for the
treatment of IPF is 801 mg three times a day. LYT-100 is designed
to potentially improve upon this regimen. In a previously conducted
single-dose crossover study, an 801 mg dose of LYT-100 resulted in
greater drug exposure than an 801 mg dose of pirfenidone. In part 1
of the multiple ascending dose study, LYT-100 was well-tolerated at
a dose above 801 mg.
Additional Phase 1 studies and future development plans
Given that the maximum tolerated dose for LYT-100 was not
determined in the original Phase 1 study, PureTech initiated a
second multiple ascending dose study earlier this year to evaluate
higher doses of the drug in healthy volunteers. PureTech also
initiated additional Phase 1 studies to further evaluate the PK,
dosing and tolerability of LYT-100 in healthy volunteers and
healthy older adults to inform the clinical development of LYT-100
across multiple indications. Results from these studies are
expected in the first quarter of 2022.
About LYT-100
LYT-100 is PureTech's most advanced therapeutic candidate from
within its Wholly Owned Pipeline. A deuterated form of pirfenidone,
an approved anti-inflammatory and anti-fibrotic drug, LYT-100 is
being advanced for the potential treatment of conditions involving
inflammation and fibrosis, including lung disease (e.g., IPF and
potentially other PF-ILDs and Long COVID respiratory complications
and related sequelae), and disorders of lymphatic flow, such as
lymphedema. PureTech is also exploring the potential evaluation of
LYT-100 in other inflammatory and fibrotic conditions such as
myocardial, kidney and other organ system fibrosis based on
clinical data around the use of pirfenidone in these
indications.
PureTech completed a Phase 1 multiple ascending dose and food
effect study evaluating LYT-100 in healthy volunteers and found it
to be well-tolerated at all doses tested. In the fourth quarter of
2020, PureTech initiated a Phase 2 trial evaluating LYT-100 as a
potential treatment for Long COVID respiratory complications and
related sequalae and a Phase 2a proof-of-concept study evaluating
LYT-100 in patients with breast cancer-related, upper limb
secondary lymphedema. PureTech has also initiated additional Phase
1 clinical trials to further explore the PK, dosing and
tolerability of LYT-100 in healthy volunteers. Results from these
trials are expected to provide additional supportive data to inform
the clinical development of LYT-100 across multiple
indications.
(1) Long COVID is a term being used to describe the emerging and
persistent complications following the resolution of COVID-19
infection, also known as post-acute COVID-19 syndrome (PACS).
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 25 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 Half Year 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 the Company's unique
insights into the biology of the brain, immune and gut, or BIG,
systems and the interface between those systems, referred to as the
BIG Axis.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @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 statements
that relate to our expectations regarding the potential therapeutic
benefit and administration of LYT-100 in patients, including its
ability to potentially address certain shortcomings with respect to
current standards of care, expectations regarding the clinical
development of LYT-100 and the timing for completing enrollment in,
or generating data and results from, our current Phase 1 and 2
trials of LYT-100, the potential of clinical data to provide
support for further development of LYT-100 across multiple
indications, the timing of updates from the Company with respect to
future development plans for LYT-100 or other product candidates,
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, 2020
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:
Investors EU media
Allison Mead Talbot Ben Atwell, Rob Winder
+1 617 651 3156 +44 (0) 20 3727 1000
amt@puretechhealth.com ben.atwell@FTIconsulting.com
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 or visit www.rns.com.
Reach is a non-regulatory news service. By using this service an
issuer is confirming that the information contained within this
announcement is of a non-regulatory nature. Reach announcements are
identified with an orange label and the word "Reach" in the source
column of the News Explorer pages of London Stock Exchange's
website so that they are distinguished from the RNS UK regulatory
service. Other vendors subscribing for Reach press releases may use
a different method to distinguish Reach announcements from UK
regulatory news.
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.
END
NRAGPGWAGUPGPPA
(END) Dow Jones Newswires
November 16, 2021 07:00 ET (12:00 GMT)
Puretech Health (LSE:PRTC)
Historical Stock Chart
From Jun 2024 to Jul 2024
Puretech Health (LSE:PRTC)
Historical Stock Chart
From Jul 2023 to Jul 2024