SPT-300 demonstrated nine times greater
allopregnanolone exposure in humans dosed orally than published
data for oral allopregnanolone,1 validating Glyph™ platform’s
ability to enhance oral bioavailability
In a Phase 2a trial, SPT-3002 substantially
reduced stress-induced levels of cortisol, supporting Seaport’s
planned studies in mood and anxiety disorders, including anxious
depression
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company, noted that
its Founded Entity, Seaport Therapeutics, a biopharmaceutical
company that is charting a proven path in neuropsychiatry, today
announced two poster presentations detailing the results from
multiple clinical trials of SPT-300 at the Society of Biological
Psychiatry Annual Meeting in Austin, TX. SPT-300 has been shown to
retain the activity and potency of natural allopregnanolone in an
oral form and has the potential to capture the breadth of the
naturally occurring neurosteroid, which is believed to have
significant therapeutic potential in a range of mood and anxiety
disorders, including anxious depression. The presentations detail
data from the first-in-human, multi-part Phase 1 trial of SPT-300
and the Phase 2a trial of SPT-300 in the Trier Social Stress Test,
a validated clinical model of anxiety in healthy volunteers, and
include assessment of safety, tolerability, efficacy, oral
bioavailability and GABAA receptor target engagement.
The full text of the announcement from Seaport is as
follows:
Seaport Therapeutics Presents Data from
Multiple SPT-300 Trials at Society of Biological Psychiatry (SOBP)
Annual Meeting
SPT-300 demonstrated nine times greater
allopregnanolone exposure in humans dosed orally than published
data for oral allopregnanolone, validating Glyph™ platform’s
ability to enhance oral bioavailability
In a Phase 2a trial, SPT-300 substantially
reduced stress-induced levels of cortisol, supporting Seaport’s
planned studies in mood and anxiety disorders, including anxious
depression
BOSTON, May 9, 2024 – Seaport Therapeutics, a
clinical-stage biopharmaceutical company that is charting a proven
path in neuropsychiatry, today announced two poster presentations
detailing the results from multiple clinical trials of SPT-300 at
the Society of Biological Psychiatry (SOBP) Annual Meeting in
Austin, TX. SPT-300 has been shown to retain the activity and
potency of natural allopregnanolone in an oral form and has the
potential to capture the breadth of the naturally occurring
neurosteroid, which is believed to have significant therapeutic
potential in a range of mood and anxiety disorders, including
anxious depression. The presentations detail data from the
first-in-human, multi-part Phase 1 trial of SPT-300 and the Phase
2a trial of SPT-300 in the Trier Social Stress Test (TSST), a
validated clinical model of anxiety in healthy volunteers, and
include assessment of safety, tolerability, efficacy, oral
bioavailability and GABAA receptor target engagement.
“These data summarize some of the evidence supporting the core
mechanisms of SPT-300 as we advance to later-stage clinical
studies. Our proprietary GlyphTM platform allows SPT-300 to be
absorbed like a dietary fat through the intestinal lymphatic system
and transported into circulation. We believe this will address
allopregnanolone’s naturally low bioavailability but retain its
endogenous mechanism and range of potential therapeutic effects,”
said Michael Chen, Ph.D., Co-founder and Chief Scientific Officer
of Seaport Therapeutics. “These data validate that SPT-300 has the
potential to make a difference for patients suffering from
depression, anxiety and other neuropsychiatric conditions and also
provides further validation for our Glyph platform as an elegant
solution to multiple key obstacles in neuropsychiatric drug
development.”
Details of the poster presentations at SOBP
Title: A First-in-Human Phase 1 Study of SPT-300, A
First-in-Class Orally Bioavailable Prodrug of the Neurosteroid
Allopregnanolone that is Absorbed via the Lymphatic System
Presenter: Michael C. Chen, Ph.D.
The topline results from the completed, multi-part Phase 1 trial
of SPT-300 were reported in December 2022. Overall, the Phase 1
trial was well tolerated and evaluated oral bioavailability,
safety, tolerability, pharmacokinetics and GABAA target engagement.
This study included double-blind single ascending dose, multiple
ascending dose and open-label food effect parts.
Allopregnanolone is an endogenous neurosteroid of GABAA positive
allosteric modulator with validated anti-depressant and anxiolytic
activity, but orally administered allopregnanolone is poorly
bioavailable. SPT-300 is absorbed through the intestinal lymphatic
system, allowing it to avoid first-pass metabolism. Out of 99
participants enrolled in the first-in-human study, allopregnanolone
exposure from SPT-300 was approximately nine times greater than
published data for oral allopregnanolone. SPT-300 was generally
well-tolerated and resulted in pharmacodynamic effects consistent
with GABAA positive allosteric modulation. The pharmacodynamic and
pharmacokinetic properties demonstrated warrant further clinical
development. No treatment-related severe or serious adverse events
(AE) were reported, and the most common AE was somnolence, which
was mild in all cases.
Title: SPT-300, an Oral Prodrug of Allopregnanolone,
Potentially Reduces Salivary Cortisol Response to the Trier Social
Stress Test in a Randomized, Placebo-Controlled Trial in Healthy
Participants
Presenter: Michael C. Chen, Ph.D.
The topline results from Seaport’s SPT-300 Phase 2a
proof-of-concept trial were reported in November 2023. The
potential of SPT-300 to reduce physiological stress was tested in a
randomized, placebo-controlled study using the TSST, a validated
clinical model of anxiety in healthy volunteers exposed to
unpredictable, novel, anticipatory and social stress.
Among the enrolled healthy volunteers, SPT-300 substantially
reduced salivary cortisol at all post-TSST timepoints compared to
placebo and SPT-300 treated participants had significantly reduced
cortisol versus placebo from baseline to peak (p=0.0001), meeting
the study’s primary endpoint and demonstrating that SPT-300
regulates hypothalamic-pituitary-adrenal axis reactivity to acute
stress. The most common treatment-emergent adverse event was
somnolence (29% SPT-300 vs. 13% placebo), which was transient and
mild or moderate. SPT-300 was generally well-tolerated and
demonstrated GABA modulatory pharmacological activity that merits
further investigation in stress-related mood and anxiety disorders,
including anxious depression.
About SPT-300
SPT-300 (Glyph-allopregnanolone), an oral prodrug of
allopregnanolone, an endogenous neurosteroid, is in clinical stage
development for the treatment of mood and anxiety disorders,
including anxious depression. Allopregnanolone has demonstrated
therapeutic benefit in a range of neuropsychiatric conditions, but
it is only approved as an intravenous infusion, which has limited
the scope of its clinical use. Using the Glyph platform, SPT-300
retains the activity and potency of endogenous allopregnanolone in
an oral form and has the potential to capture the breadth of the
natural biological response. In a Phase 2a clinical trial, SPT-300
demonstrated proof-of-concept in a validated clinical model of
anxiety in healthy volunteers. SPT-300 also demonstrated oral
bioavailability, tolerability and γ-aminobutyric-acid type A
(GABAA) receptor target engagement in healthy volunteers in a Phase
1 clinical trial.
About the GlyphTM Platform
Glyph is Seaport's proprietary technology platform which uses
the lymphatic system to enable and enhance the oral administration
of drugs. With the Glyph platform, drugs are absorbed like dietary
fats through the intestinal lymphatic system and transported into
circulation. Seaport believes the Glyph technology has the
potential to be widely applied to many therapeutic molecules that
have high first-pass metabolism leading to low bioavailability
and/or side effects, including hepatotoxicity. The Glyph platform
has been refined at Seaport to efficiently generate multiple
therapeutic candidates within the company’s pipeline. Seaport has
exclusively licensed this technology from Monash University based
on the pioneering research of the Porter research group, along with
the co-inventors from PureTech Health and Seaport. The group and
its collaborators have published research in Nature Metabolism,
Frontiers in Pharmacology and the Journal of Controlled Release
supporting the Glyph platform's capabilities.
About Seaport Therapeutics
Seaport Therapeutics is a clinical-stage biopharmaceutical
company advancing the development of novel neuropsychiatric
medicines in areas of high unmet patient needs. The Company has a
proven strategy of advancing clinically validated mechanisms
previously held back by limitations that are overcome with its
proprietary GlyphTM technology platform. All the therapeutic
candidates in its pipeline of first and best-in-class medicines are
based on the Glyph platform, which is uniquely designed to enable
oral bioavailability, bypass first-pass metabolism and reduce
hepatotoxicity and other side effects. Seaport is led by an
experienced team that was involved in inventing and advancing KarXT
and other neuropsychiatric medicines and are guided by an extensive
network of renowned scientists, clinicians and key opinion leaders
across neurological specialties. For more information, please visit
www.seaporttx.com.
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 29 therapeutics and therapeutic candidates,
including two that have received both U.S. FDA clearance and
European marketing authorization and a third (KarXT) that has been
filed 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 X (formerly 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
without limitation those related to the therapeutic potential of
SPT-300, our expectations regarding the Glyph platform including
the potential for new treatment applications, Seaport’s development
plans 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, 2023,
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 U.S. Food and Drug Administration. (2018). FDA drug approval
package: Zulresso (Application No. 211,371) 2SPT-300, formerly
known as LYT-300
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