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.
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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
US Media Justin Chen +1 609 578 7230
justin@tenbridgecommunications.com
PureTech Health (NASDAQ:PRTC)
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