TIDMPRTC
PureTech Health PLC
23 August 2021
23 August 2021
PureTech Presents Phase 1 Data for LYT-100 at the European
Respiratory Society International Congress 2021
LYT-100 was well-tolerated when given twice-daily over multiple
ascending doses with no maximum tolerated dose observed
Results demonstrated dose-proportional PK profile and a modest
food effect
LYT-100 is currently being evaluated in two Phase 2 trials in
patients with Long COVID respiratory complications or breast
cancer-related, upper limb secondary lymphedema, and planning is
underway to potentially evaluate LYT-100 in IPF
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
presentation of the Phase 1 multiple ascending dose and food effect
study of LYT-100 at the virtual European Respiratory Society
International Congress. LYT-100 is the lead therapeutic candidate
from within PureTech's Wholly Owned Pipeline, and it is being
advanced for the potential treatment of conditions involving
inflammation and fibrosis and disorders of lymphatic flow.
"These data further support the favorable tolerability profile
of LYT-100 and have helped inform both our ongoing Phase 2 trials
as well as potential future trials in additional indications,
including idiopathic pulmonary fibrosis," said Michael Chen, PhD,
Head of Innovation at PureTech. "LYT-100 is a deuterated form of
pirfenidone, which retains the beneficial pharmacology of
pirfenidone and also appears to have a favorable tolerability
profile based on the preclinical and clinical data generated thus
far. We believe this molecule has the potential to overcome the GI
adverse events associated with the current standards of care and
become the frontline treatment for patients with interstitial lung
disease."
Multiple ascending dose and food effect study results
The Phase 1 multiple ascending dose food and effect study was a
randomized, double-blind, placebo-controlled study of LYT-100 in
healthy volunteers in both fed and fasting states. Plasma
concentrations of LYT-100 and its metabolites were measured to
determine pharmacokinetic (PK) parameters.
Topline results from the Phase 1 study were first announced in
November 2020. The expanded analysis details the safety,
tolerability and favorable PK profile of LYT-100 at doses from
100mg to 1000mg in both fed and fasting healthy volunteers and
supports the potential for twice-daily dosing in future
studies.
A dose-proportional PK profile was observed with LYT-100
throughout the range of doses studied. In the single ascending food
effect cohort, exposure was slightly lower in the fed condition.
The ratios of exposure during fed conditions were approximately 20%
to 25% less than exposure during fasting.
Given that the maximum tolerated dose for LYT-100 was not
determined in this study, PureTech initiated a second multiple
ascending dose study earlier this year to evaluate higher doses of
the drug in healthy volunteers.
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 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 three
additional Phase 1 clinical trials to explore further the PK,
dosing and tolerability of LYT-100 in healthy volunteers. Results
from these trials are anticipated in the fourth quarter of 2021 and
are expected to provide additional supportive data that may inform
the clinical development of LYT-100 across indications, including
IPF and other PF-ILDs.
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 26 therapeutics and therapeutic
candidates, including two that have received FDA clearance and
European marketing authorization, as of the date of PureTech's most
recently filed Annual Report on Form 20-F. 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 statements that are or may be
forward-looking statements, including statements that relate to our
product candidates and approach towards addressing major diseases,
future prospects, developments, and strategies. The forward-looking
statements are based on current expectations and are subject to
known and unknown risks and uncertainties that could cause actual
results, performance and achievements to differ materially from
current expectations, including, but not limited to, our
expectations regarding the potential therapeutic benefit of LYT-100
in patients with conditions involving inflammation and fibrosis and
disorders of lymphatic flow, expectations regarding data from our
current Phase 1 and 2 trials of LYT-200 and their potential to
provide supportive data for further development and those risks and
uncertainties described in the risk factors included in the
regulatory filings for PureTech Health plc. 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, neither the company
nor any other party intends 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
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