PureTech Announces New Therapeutic Candidate, LYT-310, an Oral Form of Cannabidiol (CBD) Leveraging PureTech’s Glyph™ Platform
November 30 2022 - 7:00AM
Business Wire
LYT-310 demonstrated three to fourfold increase
in oral bioavailability of CBD compared to unmodified CBD in a
preclinical model
Oral dosing and potential for improved
tolerability could expand therapeutic application of CBD across a
wider range of age groups and indications, including both rare and
more common forms of epilepsy and other central nervous system
disorders
Further proof of Glyph platform’s ability to
enable oral administration of certain small molecules with
otherwise limited oral bioavailability
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company dedicated to
changing the treatment paradigm for devastating diseases, today
announced the nomination of a new therapeutic candidate, LYT-310,
which is an oral cannabidiol (CBD) prodrug and the second
therapeutic candidate developed from PureTech’s Glyph™ platform to
be advanced toward the clinic. Clinical studies of LYT-310 are
expected to begin in Q4 of 2023.
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PureTech announced the nomination of a
new therapeutic candidate, LYT-310, which is an oral cannabidiol
(CBD) prodrug and the second therapeutic candidate developed from
PureTech’s Glyph™ platform to be advanced toward the clinic. Oral
capsule dosing and the potential for improved tolerability could
expand the therapeutic application of CBD across a wider range of
age groups and indications, including both rare and more common
forms of epilepsy and other central nervous system disorders.
(Graphic: Business Wire)
A CBD-based product has received regulatory approval in the
United States and Europe to treat seizures resulting from certain
rare conditions, but it requires a large volume of a sesame
oil-based formulation, which limits its use in broader indications
and age groups. PureTech’s LYT-310 is designed to greatly expand
the therapeutic application and potential of CBD by:
- enabling oral administration in a capsule;
- expanding the use of CBD into a broad range of therapeutic
areas and patient populations (such as adolescents and adults)
where higher doses are required to achieve a therapeutic
effect;
- potentially improving safety and reducing gastrointestinal (GI)
tract side effects that are associated with the currently approved
CBD-based treatment by reducing GI and liver exposure; and
- allowing for a readily scalable, consistent product in a
cost-effective manner.
“The nomination of LYT-310 is an exciting expansion of
PureTech’s Glyph technology,” said Daniel Bonner, Ph.D., Vice
President at PureTech Health. “The data generated to date with
LYT-310 further demonstrate our ability to apply the Glyph
technology to an array of molecules to enable or greatly enhance
oral bioavailability. This approach allows us to unlock the
therapeutic potential of a range of molecules with validated
efficacy whose development has been limited by first pass
metabolism by the liver.”
In multiple preclinical models, including large animal and
non-human primate, LYT-310 has demonstrated a three to fourfold
increase in oral exposure vs. unmodified CBD in a fasted state.
This has the potential to translate into improved safety and
reduced side effects. Lymphatic transport has also been confirmed
in preclinical models, with up to 30% of LYT-310 entering the
lymphatics, compared to 5% for unmodified CBD – which further
supports the novel Glyph mechanism of enhancing
bioavailability.
The first candidate from the Glyph technology platform, LYT-300
(oral allopregnanolone), is currently being evaluated in a
multi-part Phase 1 trial designed to demonstrate oral
bioavailability, evaluate safety and tolerability across a range of
doses, and to inform dose selection moving forward. The first
objective was achieved earlier this year, and LYT-300 demonstrated
oral bioavailability of allopregnanolone approximately ninefold
greater than that of orally administered allopregnanolone, based on
previously published data. The Phase 1 clinical trial is expected
to be completed by the end of 2022, and – based on the data – a
Phase 1b/2a clinical trial is planned to initiate in 2023.
About the GlyphTM 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 certain 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 certain orally
administered drugs that would otherwise be limited by first-pass
liver metabolism. PureTech is accelerating development of a Glyph
portfolio that leverages validated efficacy, prioritizing highly
characterized drugs to evaluate the ability of the Glyph technology
to improve oral bioavailability or lymphatic targeting. PureTech’s
lead Glyph therapeutic candidate, LYT-300 (oral allopregnanolone),
is currently being evaluated in a multi-part Phase 1 clinical trial
that is expected to read out by the end of 2022. A second
therapeutic candidate, LYT-310 (oral cannabidiol), is expected to
enter the clinic in Q4 of 2023. PureTech has a robust intellectual
property portfolio that includes licensed patents as well as wholly
owned patents, covering 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 Medicine,
Angewandte Chemie 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 biotherapeutics company dedicated to changing the
treatment paradigm for devastating diseases. 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 28 therapeutics and therapeutic
candidates, including two (Plenity® and EndeavorRx®) that have
received both U.S. FDA clearance and European marketing
authorization and a third (KarXT) that will soon be filed for FDA
approval, as of the most recent update by the Company. 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 unique insights in immunology and drug development.
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, including without limitation
those statements that relate to the potential for improved
tolerability associated with LYT-310 as compared to unmodified CBD,
that such potential improved tolerability and oral dosing could
expand the therapeutic application of CBD across a wider range of
age groups and indications, our expectations regarding the Glyph™
technology platform including the potential for new treatment
applications, the applicability of preclinical results to human
subjects, the timing of clinical trials associated with LYT-300 ,
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, 2021
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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PureTech Public Relations
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Media Nichole Sarkis +1 774 278 8273
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