TIDMPRTC
PureTech Health PLC
07 December 2021
7 December 2021
PureTech Health plc
PureTech Advances Wholly-Owned Candidate LYT-300 (Oral
Allopregnanolone) into Clinical Study for Potential Treatment of
Neurological and Neuropsychological Conditions
LYT-300 is the first candidate from the Glyph(TM) technology
platform to enter the clinic, making it the third clinical-stage
candidate from PureTech's pipeline
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, announced today the initiation
of a clinical study of LYT-300 (oral allopregnanolone), PureTech's
wholly-owned therapeutic candidate for the potential treatment of
neurological and neuropsychological conditions, including
depression, anxiety, sleep disorders, fragile X tremor-associated
syndrome, essential tremor and epileptic disorders, among others.
LYT-300 is the third clinical-stage, wholly-owned candidate from
PureTech's pipeline.
LYT-300 is an oral form of allopregnanolone. Allopregnanolone is
a natural neurosteroid that is a positive allosteric modulator of
<GAMMA>-aminobutyric-acid type A (GABA(A) ) receptors, which
are known to play a key biological role in depression, epilepsy and
other neurological and neuropsychological conditions. Natural
allopregnanolone has poor oral bioavailability, thus limiting its
development as a therapeutic. An injectable formulation of
allopregnanolone is approved by the United States Food and Drug
Administration (FDA) as a 60-hour infusion for the treatment of
post-partum depression, though the method of administration has
limitations. LYT-300 is designed to unlock the validated biology of
allopregnanolone to potentially offer a new, oral treatment option
for a range of conditions where there is significant patient
need.
"Allopregnanolone is a powerful, natural regulator of mood
disorders and other neurological conditions, but its therapeutic
development has been limited by its poor oral bioavailability.
Synthetic oral analogs of allopregnanolone have been developed,
though the degree to which these compounds mimic the therapeutic
effects of natural allopregnanolone remains to be seen," said Joe
Bolen, Ph.D., Chief Scientific Officer of PureTech. "LYT-300 is
designed to preserve the natural structure of allopregnanolone in
an oral dosage form, which we believe could potentially offer
much-needed treatment options in large indications, such as
depression, anxiety and sleep, as well as for more rare conditions,
including certain epileptic disorders. Advancing LYT-300 into human
clinical development offers the opportunity to potentially address
many important psychiatric conditions without good treatment
options, especially amid the growing mental health crisis in the
United States wherein one in four adults report experiencing
symptoms of depression or anxiety."
LYT-300 was developed from PureTech's proprietary Glyph
technology platform, which generates novel prodrugs by reversibly
linking small molecule drugs to dietary fat molecules. This linkage
is designed to enable the transport of small molecule drugs
directly into systemic circulation via the lymphatic system
following oral administration, thereby bypassing first-pass liver
metabolism. This platform also has the potential to deliver other
drugs with poor bioavailability, including immune modulators that
could directly target the mesenteric lymph nodes.
The Phase 1 study of LYT-300 involves multiple parts, including
the evaluation of a single ascending dose, multiple ascending doses
and the effect of food on oral absorption of the prodrug in healthy
volunteers. Safety, tolerability and pharmacokinetics (PK) will be
assessed. Given the GABA(A) receptor modulating activity of
allopregnanolone, the study will also explore the impact of LYT-300
on b -EEG, a marker of GABA(A) target engagement, thus potentially
providing early insights into the mechanistic effects of LYT-300.
Results from the study are expected in the second half of 2022 and
will be used to inform the design of possible future studies
evaluating LYT-300 in indications that could include depression,
anxiety, sleep disorders, fragile X tremor-associated syndrome,
essential tremor and epileptic disorders, among others.
About LYT-300
LYT-300 is a clinical therapeutic candidate that is in
development as a potential treatment for a range of neurological
and neuropsychological conditions. Developed using PureTech's Glyph
technology platform, LYT-300 is an oral prodrug of natural
allopregnanolone. An IV formulation of allopregnanolone is approved
by the U.S. FDA and administered as a 60-hour infusion for the
treatment of post-partum depression. Allopregnanolone is a positive
allosteric modulator of <GAMMA>-aminobutyric-acid type A
(GABA(A) ) receptors and has been shown to regulate mood and other
neurological conditions. PureTech initiated a Phase 1 clinical
study of LYT-300 in late 2021, which is designed to characterize
the safety, tolerability and PK of orally administered LYT-300 in
healthy volunteers.
About the Glyph(TM) Technology Platform
Glyph is PureTech's synthetic lymphatic-targeting chemistry
platform which is designed to employ the lymphatic system's natural
lipid absorption and transport process to enable the oral
administration of therapeutics. Glyph reversibly links a drug to a
dietary fat molecule, creating a novel prodrug. The linked fat
molecule re-routes the drug's normal path to the systemic
circulation, bypassing the liver and instead moving from the gut
into the lymphatic vessels that normally process dietary fats.
PureTech believes this technology has the potential to (1) enable
direct modulation of the immune system via drug targets present in
mesenteric lymph nodes and (2) provide a broadly applicable means
of enhancing the bioavailability of orally administered drugs that
would otherwise be reduced by first-pass liver metabolism. PureTech
is leveraging validated biology to accelerate the development of a
Glyph portfolio, prioritizing highly characterized drugs to enhance
with the Glyph technology based on the potential value unlocked in
improving their oral bioavailability or lymphatic targeting.
PureTech's lead Glyph therapeutic candidate, LYT-300 (oral
allopregnanolone), is being evaluated in a Phase 1 study, with
results expected in the second half of 2022. PureTech has
exclusively licensed the Glyph technology platform, which is based
on the pioneering research of Christopher Porter, Ph.D., and his
research group at the Monash Institute of Pharmaceutical Sciences
at Monash University. The Porter Research Group and collaborators
have published research in Nature Metabolism and the Journal of
Controlled Release supporting the Glyph platform's ability to
directly target the lymphatic system with a variety of
therapies.
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 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 the treatment potential of LYT-300, including
possible additional indications, the applicability of clinical
results to human subjects, the Phase 1 LYT-300 clinical study,
including its design, associated timelines, and how it may inform
future clinical studies, and our expectations regarding the
Glyph(TM) technology platform. 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
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