11
December 2024
PureTech
Health plc
PureTech Founded Entity
Seaport Therapeutics Presents Additional Data from Phase 1 Study
of
SPT-300 at ACNP Annual
Meeting 2024
Multiple well-tolerated
doses with pharmacodynamic activity were identified and will be
included in a planned Phase 2b study in major depressive
disorder
PureTech Health plc
(Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company, noted that
its Founded Entity, Seaport
Therapeutics, ("Seaport")
a clinical-stage biopharmaceutical company that is
advancing novel neuropsychiatric medicines with a proven strategy
and team, today announced the presentation of additional data from
its first-in-human, multi-part Phase 1 study of SPT-300 in healthy
volunteers at the American College of Neuropsychopharmacology
(ACNP) Annual Meeting, held December 8-11, 2024 in Phoenix,
Arizona. SPT-300 is an oral prodrug of
allopregnanolone that is designed to retain the pharmacological
activity of allopregnanolone, an endogenous neurosteroid.
Allopregnanolone has been clinically validated in third-party
trials as a rapidly acting antidepressant with anxiolytic effects.
New data presented at the conference
include further safety analyses and pharmacokinetic and
pharmacodynamic data. Based on the Phase 1 study results, the
profile of SPT-300 is suitable for chronic dosing and oral
administration at night in the planned Phase 2b placebo-controlled
study.
The full text of the announcement
from Seaport is as follows:
Seaport Therapeutics Presents
Additional Data from Phase 1 Study of SPT-300 at ACNP Annual
Meeting 2024
Multiple well-tolerated
doses with pharmacodynamic activity were identified and will be
included in a planned Phase 2b study in major depressive
disorder
BOSTON, December 11, 2024 - Seaport Therapeutics ("Seaport" or the "Company"), a
clinical-stage biopharmaceutical company that is advancing novel
neuropsychiatric medicines with a proven strategy and team, today
announced the presentation of additional data from its
first-in-human, multi-part Phase 1 study of SPT-300 in healthy
volunteers at the American College of Neuropsychopharmacology
(ACNP) Annual Meeting, held December 8-11, 2024 in Phoenix,
Arizona. SPT-300 is an oral prodrug of allopregnanolone that is
designed to retain the pharmacological activity of
allopregnanolone, an endogenous neurosteroid. Allopregnanolone has
been clinically validated in third-party trials as a rapidly acting
antidepressant with anxiolytic effects.
The Phase 1 study enrolled 99 participants (in
three parts: double-blind single ascending dose, multiple ascending
dose, and open-label food effect) and evaluated oral
bioavailability, safety, tolerability, pharmacokinetics and
GABAA target engagement. Pharmacodynamic assessments
included quantitative electroencephalography (EEG) analyses of
brain function and video-oculography (VOG) assessments of eye
movement. SPT-300 was well-tolerated, with all adverse events (AE)
being mild or moderate, transient and dose-dependent. The most
common AE was somnolence, which was mild and transient in all
cases. The study showed that SPT-300 had therapeutically relevant
blood levels that were up to approximately nine times greater than
published data on orally administered unmodified allopregnanolone,
which has minimal bioavailability.
New data in the poster presented at
the conference include further safety analyses and pharmacokinetic
and pharmacodynamic data. In the Phase 1 study, increases in EEG
beta frequency power and reduction in saccadic eye velocity were
observed at approximately 4 hours post-dose. Somnolence peaked in
this same timeframe and diminished by 6 to 8 hours post-dose,
consistent with both pharmacodynamic markers and blood levels of
allopregnanolone. Based on the Phase 1 study results, the profile
of SPT-300 is suitable for chronic dosing and oral administration
at night in the planned Phase 2b placebo-controlled study in major
depressive disorder with or without anxious distress.
"Together with previous clinical
efficacy data, the further analyses of the Phase 1 study
demonstrate that these doses of SPT-300 are well-tolerated and have
rapidly acting pharmacodynamic activity. This reinforces our
confidence in SPT-300 as an oral modulator of GABAA
receptors and as a potential rapidly acting antidepressant and
anxiolytic agent," said Tony Loebel, M.D., Chief Medical Officer
and President of Clinical Development of Seaport Therapeutics.
"There is a great need for innovative neuropsychiatric medicines,
and an oral form of allopregnanolone has the potential to provide
important advantages that we believe will allow for once-daily use
on a chronic basis. We look forward to the next phase of our
clinical development plan for SPT-300."
About SPT-300
SPT-300 (Glyph allopregnanolone), an
oral prodrug of allopregnanolone, an endogenous neurosteroid, is in
clinical stage development for the treatment of major depressive
disorder (MDD) with or without anxious distress. Allopregnanolone
has demonstrated therapeutic benefit in a range of neuropsychiatric
conditions, but is currently only approved as an intravenous
infusion, which has limited the scope of its clinical use. Using
the Glyph™ platform, SPT-300 is designed to retain the activity,
potency and the breadth of the natural biological response of
endogenous allopregnanolone in an oral form, which has the
potential to capture clinically important antidepressant and
anxiolytic effects. In a Phase 2a clinical study, SPT-300
demonstrated initial 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 study.
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 Glyph technology platform. All
the therapeutic candidates in its pipeline of potentially 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 liver enzyme elevations or hepatotoxicity and
other side effects. Seaport is led by an experienced team that
invented and advanced important neuropsychiatric medicines and is
guided by an extensive network of renowned scientists, clinicians
and key opinion leaders. 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 three that have
been approved by the U.S. Food and Drug Administration. 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 Seaport's
development plans for its pipeline of therapeutics for the
treatment of depression, anxiety and other neuropsychiatric
disorders, potential benefits to patients, and Seaport's 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.
Contact:
PureTech
Public Relations
publicrelations@puretechhealth.com
Investor Relations
IR@puretechhealth.com
UK/EU Media
Ben Atwell, Rob Winder
+44 (0) 20 3727 1000
puretech@fticonsulting.com
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Media
Justin Chen
+1 609 578 7230
justin@tenbridgecommunications.com
