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 COVID1 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.
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Today PureTech 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. 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.
(Graphic: Business Wire)
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® (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.
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.
_________________ 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).
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version on businesswire.com: https://www.businesswire.com/news/home/20211116005332/en/
Investors Allison Mead Talbot +1 617 651 3156
amt@puretechhealth.com
U.S. media Nichole Sarkis +1 774 278 8273
nichole@tenbridgecommunications.com
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