RCS - PureTech Health PLC - PRTC's Seaport Presents Ph1 SPT-300 Data at ACNP

Puretech HealthAnnouncement

11/12/2024 12:15

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20241211:nRSK6024Pa&default-theme=true

RNS Number : 6024P  PureTech Health PLC  11 December 2024

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 (https://puretechhealth.com/) (Nasdaq: PRTC, LSE: PRTC)
("PureTech" or the "Company"), a clinical-stage biotherapeutics company, noted
that its Founded Entity, Seaport Therapeutics (https://seaporttx.com/) ,
("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
GABA(A) 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 GABA(A) 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 (GABA(A)) 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
(http://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 (mailto:publicrelations@puretechhealth.com)

Investor Relations

IR@puretechhealth.com (mailto:IR@puretechhealth.com)

 

UK/EU Media

Ben Atwell, Rob Winder

+44 (0) 20 3727 1000

puretech@fticonsulting.com (mailto:puretech@fticonsulting.com)

 

US Media

Justin Chen

+1 609 578 7230

justin@tenbridgecommunications.com (mailto:justin@tenbridgecommunications.com)

 

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAKZMMZGMVGDZG