TIDMPRTC
PureTech Health PLC
21 June 2023
21 June 2023
PureTech Health plc
PureTech Initiates Phase 2a Clinical Trial of LYT-300 (Oral
Allopregnanolone) for the Potential Treatment of Anxiety
Disorders
Results from a validated clinical model of anxiety in healthy
volunteers anticipated by the end of 2023
Phase 2a clinical trial of LYT-300 in patients with postpartum
depression planned to initiate in second half of 2023
LYT-300 is derived from PureTech's Glyph (TM) platform, which is
designed to enable oral administration of a range of
therapeutics
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company dedicated to
changing the lives of patients with devastating diseases , today
announced the initiation of a Phase 2a proof-of-concept clinical
trial of LYT-300 (oral allopregnanolone) in healthy volunteers
using a validated clinical model of anxiety. LYT-300 is PureTech's
wholly-owned therapeutic candidate for the potential treatment of
neurological and neuropsychiatric disorders, including anxiety
disorders and postpartum depression (PPD). LYT-300 is an oral
prodrug of allopregnanolone that was developed using PureTech's
Glyph (TM) platform, which harnesses the body's natural lipid
absorption and transport process to enable the oral administration
of certain therapeutics that otherwise cannot be administered
orally.
"Anxiety disorders are the most common mental disorder,[1]
impacting nearly 30% of adults at some point in their lives.[2]
Despite this, there has been very little clinical development in
the last 20 years - especially when compared to other psychiatric
conditions," said Eric Elenko, Ph.D., Chief Innovation Officer at
PureTech. "We believe that our Glyph technology platform is
positioned to unlock the therapeutic potential of a range of
molecules, beginning with allopregnanolone, and we look forward to
the results of this study as well as the initiation of a study with
LYT-300 in postpartum depression later this year."
In December 2022, PureTech announced positive topline results
from the completed, multi-part Phase 1 study of LYT-300. The data
showed that oral administration of LYT-300 achieved blood levels of
allopregnanolone at or above those associated with therapeutic
benefit in PPD and nine times greater than orally administered
allopregnanolone, based on third-party published data.[3] LYT-300
also demonstrated dose-dependent target engagement with GABA(A)
receptors, which are known to regulate mood and other neurological
conditions.
Allopregnanolone and related endogenous neurosteroids have been
recognized for their potential to treat depression and other
neurological and neuropsychiatric indications with a rapid onset of
action. The major hurdles associated with endogenous neurosteroids
in the past have been the inability to create oral formulations and
chronically administer them to patients. An intravenous formulation
of allopregnanolone is approved by the U.S. Food and Drug
Administration as a 60-hour infusion for the treatment of
postpartum depression, though the method of administration has
significant challenges and limits the scope of clinical translation
with this class of compounds. To overcome this, medicinal chemistry
approaches have been applied to synthesize orally bioavailable
chemical analogs of allopregnanolone. These oral analogs may have
different pharmacological effects than endogenous allopregnanolone
and therefore may not capture its full therapeutic potential .
PureTech's Glyph platform is designed to address these issues by
reversibly linking allopregnanolone to a lipid, creating a novel
prodrug. The linked fat molecule re-routes the drug's normal
pathway into the systemic circulation, bypassing the liver and
instead moving directly from the gut into the lymphatic vessels
that normally process dietary fats. This technology has the
potential to provide a broadly applicable means of enhancing the
bioavailability of certain drugs that would otherwise be limited by
first-pass liver metabolism, including allopregnanolone.
Results for the placebo-controlled, Phase 2a, proof-of-concept
trial using a validated clinical model of anxiety in healthy
volunteers are anticipated by the end of 2023. Additionally, the
open-label, Phase 2a, proof-of-concept clinical trial in patients
with postpartum depression is expected to begin in the second half
of 2023.
About LYT-300
LYT-300 is a clinical therapeutic candidate that is in
development as a potential treatment of neurological and
neuropsychiatric disorders, including anxiety disorders and
postpartum depression . Developed using PureTech's Glyph(TM)
technology platform, LYT-300 is an oral prodrug of endogenous
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
GABA(A) receptor target engagement in healthy volunteers.
Allopregnanolone is a positive allosteric modulator (PAM) of
<GAMMA>-aminobutyric-acid type A (GABA(A) ) 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(TM) 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 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. Results from a placebo-controlled,
Phase 2a, proof-of-concept, trial using a validated clinical model
of anxiety in healthy volunteers are anticipated by the end of
2023. An open-label, Phase 2a, proof-of-concept clinical trial in
patients with PPD is expected to begin 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 clinical-stage biotherapeutics company dedicated
to giving life to new classes of medicine to change the lives of
patients with devastating diseases. The Company has created a broad
and deep pipeline through its experienced research and development
team and its extensive network of scientists, clinicians and
industry leaders that is being advanced both internally and through
its Founded Entities. PureTech's R&D engine has resulted in the
development of 27 therapeutics and therapeutic candidates,
including two (Plenity(R) and EndeavorRx(R)) that have received
both US FDA clearance and European marketing authorization and a
third (KarXT) that is expected to be filed soon for FDA approval. A
number of these programs are being advanced by PureTech or its
Founded Entities in various indications and stages of clinical
development, including registration enabling studies. 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.
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(TM) 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.
Contact:
PureTech
Public Relations
publicrelations@puretechhealth.com
Investor Relations
IR@puretechhealth.com
EU Media
Ben Atwell, Rob Winder
+44 (0) 20 3727 1000
ben.atwell@FTIconsulting.com
U.S. Media
Nichole Sarkis
+1 774 278 8273
nichole@tenbridgecommunications.com
[1] What are Anxiety Disorders? (n.d.). American Psychiatric
Association. Retrieved June 14, 2023, from
https://www.psychiatry.org/patients-families/anxiety-disorders/what-are-anxiety-disorders.
[2] Any Anxiety Disorder. (n.d.). National Institute of Mental
Health (NIMH). Retrieved June 14, 2023, from
https://www.nimh.nih.gov/health/statistics/any-anxiety-disorder
[3] Brexanolone NDA 211371 Multi-disciplinary Review and
Evaluation, FDA CDER, 2018.
[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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