LYT-300 is the first candidate from the GlyphTM
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.
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PureTech announced the initiation of a
Phase 1 clinical study of LYT-300 (oral allopregnanolone), its
wholly-owned therapeutic candidate for the potential treatment of a
range of neurological and neuropsychological conditions, including
depression, anxiety, sleep disorders, fragile X tremor-associated
syndrome, essential tremor and epileptic disorders, among others.
(Graphic: Business Wire)
LYT-300 is an oral form of allopregnanolone. Allopregnanolone is
a natural neurosteroid that is a positive allosteric modulator of
γ-aminobutyric-acid type A (GABAA) 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 GABAA receptor modulating activity of
allopregnanolone, the study will also explore the impact of LYT-300
on β-EEG, a marker of GABAA 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 γ-aminobutyric-acid type A (GABAA)
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™ 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 GlyphTM
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20211207005246/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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