A placebo-controlled, Phase 2a,
proof-of-concept, social anxiety clinical trial in healthy
volunteers is expected to begin in the first half of 2023, with
results anticipated by the end of 2023
An open-label, Phase 2a, proof-of-concept
clinical trial in women with postpartum depression is expected to
initiate in the second half of 2023
In a healthy volunteer study, LYT-300 achieved
blood levels of allopregnanolone at or above those associated with
therapeutic effect in postpartum depression1 and was generally
well-tolerated
Allopregnanolone is a natural neurosteroid with
proven efficacy that is currently only available as a 60-hour
intravenous infusion
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 that it will advance LYT-300 (oral allopregnanolone) for
the potential treatment of anxiety disorders and postpartum
depression (PPD). A placebo-controlled, Phase 2a, proof-of-concept,
social anxiety clinical trial in healthy volunteers is expected to
begin in the first half of 2023, with results anticipated by the
end of 2023. An open-label, Phase 2a, proof-of-concept clinical
trial in women with PPD is expected to initiate in the second half
of 2023.
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“We believe LYT-300 is the most advanced oral prodrug of natural
allopregnanolone and, as such, has the potential to unlock the full
therapeutic benefit of allopregnanolone,” said Julie Krop, M.D.,
Chief Medical Officer at PureTech. “Using our proprietary Glyph™
platform, we have made natural allopregnanolone orally bioavailable
without permanently chemically modifying the natural neurosteroid.
This differentiated approach, which harnesses the validated,
fast-acting efficacy of allopregnanolone, may offer an enhanced
therapeutic benefit to patients with a wide range of neurological
and neuropsychiatric conditions, including anxiety and postpartum
depression.”
Social Anxiety Trial Design
The placebo-controlled, Phase 2a, proof-of-concept trial will
evaluate short-term changes in anxiety-related patient reported
outcomes in approximately 50 healthy volunteers. The trial will be
conducted using a validated clinical model that simulates social
anxiety.
Postpartum Depression Trial
Design The open-label, Phase 2a, proof-of-concept trial
will evaluate LYT-300 in a small number of patients with moderate
to severe PPD. It is designed to inform dose selection of LYT-300
in this population given the known efficacy of allopregnanolone in
this population, and it will evaluate scores on the HAM-D scale as
well as other relevant pharmacodynamic markers.
Topline results from a Phase 1 trial of LYT-300 were announced
in December 2022 and showed that oral administration of LYT-300
achieved blood levels of allopregnanolone at or above those
associated with therapeutic benefit in PPD and ninefold greater
than orally administered allopregnanolone, based on third-party
published data.1 The results also demonstrated exposure-dependent
target engagement with γ-aminobutyric-acid type A (GABAA)
receptors, which have been shown to regulate mood and other
neurological conditions.
Allopregnanolone is a natural neurosteroid with well-validated
biological effects. It has demonstrated a rapid onset of action for
the treatment of depression, as well as the potential to treat
other neurological conditions, including anxiety, but its poor oral
bioavailability has limited its therapeutic potential. The United
States Food and Drug Administration (FDA) has approved a 60-hour
intravenous infusion formulation of allopregnanolone for the
treatment of PPD, though this method of administration has inherent
limitations. To overcome this, oral chemically modified analogs of
allopregnanolone have been developed, though these may not capture
the full therapeutic potential of natural allopregnanolone. To
potentially harness the broad applicability of this natural
neurosteroid through oral administration, PureTech has applied its
Glyph platform, which is designed to enable the oral administration
of certain therapeutics with low oral bioavailability due to first
pass metabolism.
“I am exceptionally proud of the progress we’ve made with the
Glyph platform, which has yielded two exciting therapeutic
candidates to date, and I believe it will be a rich source of
additional candidates for our Wholly Owned Pipeline going forward,”
said Joe Bolen, Ph.D., a member of PureTech’s Research and
Development Committee and recently retired Chief Scientific
Officer. “PureTech’s unique model includes moving resources toward
the programs with the most promise. To that end, and with a focus
on translational and clinical work, we have recently deprioritized
our Orasome Technology Platform following a key go/no go
experiment. I look forward to continuing to work with the team as a
member of the R&D Committee to advance big ideas, and I am
honored to be a part of such an innovative organization with a deep
commitment to serving patients in need.”
About Anxiety Anxiety disorders are the most common
mental disorder, affecting nearly 30% of adults.2 There are several
types of anxiety disorders, including generalized anxiety disorder,
panic disorder and social anxiety disorder. They are characterized
by feelings of excessive fear and may impact a person’s ability to
function normally.
About Postpartum Depression Postpartum depression (PPD)
is a debilitating condition that affects over 400,000 women who
have given birth in the United States.3 It is characterized by
feelings of extreme sadness, changes in energy, sleep and appetite,
and it can impact a mother’s ability to care for her child.
About LYT-300 LYT-300 is a clinical therapeutic candidate
that is in development as a potential treatment for anxiety and
postpartum depression. Developed using PureTech's Glyph™ technology
platform, LYT-300 is an oral prodrug of natural allopregnanolone.
An intravenous formulation of allopregnanolone is approved by the
United States Food and Drug Administration and administered as a
60-hour infusion for the treatment of postpartum depression.
PureTech completed a Phase 1 clinical trial of LYT-300 in 2022,
which demonstrated oral bioavailability, tolerability and GABAA
receptor target engagement in healthy volunteers. 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. Unlike benzodiazepines, allopregnanolone
can provide both transient and longer-term normalization of
overactive neural circuits because it also acts at GABA receptors
outside of synapses.4 Dual intra- and extra-synaptic GABA PAMs have
been shown to not only improve sleep,5 but also mood.1
About the Glyph™ Platform Glyph is PureTech’s
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), completed a Phase 1 clinical trial in
2022. A placebo-controlled, Phase 2a, proof-of-concept, social
anxiety clinical trial in healthy volunteers is expected to begin
in the first half of 2023, with results anticipated by the end of
2023. An open-label, Phase 2a, proof-of-concept clinical trial in
women with PPD is expected to initiate in the second half of 2023.
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
Metabolism, 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 26 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 should be considered forward-looking
statements, including without limitation those statements that
relate to our expectations around the design of and the timelines
and key milestones associated with clinical trials for LYT-300, the
therapeutic potential of LYT-300, our expectations regarding the
Glyph™ technology platform including the potential for new
treatment applications, the applicability of preclinical results to
human subjects, 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.
1 Brexanolone NDA 211371 Multi-disciplinary Review and
Evaluation, FDA CDER, 2018. 2 Any Anxiety Disorder. (n.d.).
National Institute of Mental Health (NIMH).
https://www.nimh.nih.gov/health/statistics/any-anxiety-disorder 3
Bauman, B. L. (2020, May 15). Vital Signs: Postpartum Depressive
Symptoms and Provider . . . Centers for Disease Control and
Prevention.
https://www.cdc.gov/mmwr/volumes/69/wr/mm6919a2.htm?s_cid=mm6919a2_w
4 Ghit, A. (2021, August 21). GABAA receptors: structure, function,
pharmacology, and related disorders - Journal of Genetic
Engineering and Biotechnology. SpringerOpen.
https://jgeb.springeropen.com/articles/10.1186/s43141-021-00224-0 5
Bullock, A. (2021, February 15). Zuranolone as an oral adjunct to
treatment of Parkinsonian tremor: A phase 2, open-label study.
Journal of the Neurological Sciences.
https://www.jns-journal.com/article/S0022-510X(20)30613-4/fulltext
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