RCS - PureTech Health PLC - PRTC's Seaport Presents Ph1 and Ph2a SPT-300 Data

Puretech HealthAnnouncement

09/05/2024 12:15

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RNS Number : 7008N  PureTech Health PLC  09 May 2024

9 May 2024

PureTech Health plc

 

PureTech Founded Entity 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,(1) validating
Glyph™ platform's ability to enhance oral bioavailability

 

In a Phase 2a trial, SPT-300(2) substantially reduced stress-induced levels of
cortisol, supporting Seaport's planned studies in mood and anxiety disorders,
including anxious depression

 

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/) , 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 GABA(A) 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 (https://seaporttx.com/) , 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
GABA(A) 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
Glyph(TM) 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
GABA(A) 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 GABA(A) 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 GABA(A)
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 (GABA(A))
receptor target engagement in healthy volunteers in a Phase 1 clinical trial.

 

About the Glyphä 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 (https://www.nature.com/articles/s42255-021-00457-w) , Frontiers in
Pharmacology (https://doi.org/10.3389/fphar.2022.879660) and the Journal of
Controlled Release
(https://www.sciencedirect.com/science/article/pii/S0168365921000717?via%3Dihub)
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 Glyph(TM) 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 (http://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
(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 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)

(2)SPT-300, formerly known as LYT-300

 

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

Nichole Bobbyn

+1 774 278 8273

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

 

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