RCS - PureTech Health PLC - PRTC's SPTX: New Positive GlyphAgo Ph1 Dosing Data

Puretech HealthAnnouncement

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RNS Number : 5025H  PureTech Health PLC  09 June 2026

9 June 2026

PureTech Health plc

 

PureTech Founded Entity Seaport Therapeutics Reports Positive
Multiple-Ascending Dose Data from Phase 1 Proof-of-Concept Trial of
GlyphAgo™ in Healthy Volunteers

 

PureTech Health plc (https://puretechhealth.com/)  (LSE: PRTC) ("PureTech" or
the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving
life to science and transforming innovation into value, notes that its Founded
Entity, Seaport Therapeutics, announced positive data from the
multiple-ascending dose (MAD) portion of its Phase 1 proof-of-concept clinical
trial evaluating repeat dosing of GlyphAgo™ (SPT-320), a novel, Glyphed oral
prodrug of agomelatine, in healthy volunteers. Repeat dosing of GlyphAgo
demonstrated a safety, tolerability, and pharmacokinetic (PK) profile
consistent with previously reported
(https://news.puretechhealth.com/news-releases/news-release-details/puretech-founded-entity-seaport-therapeutics-announces-positive)
 single-ascending dose (SAD) and crossover data, supporting its planned
advancement of GlyphAgo into two parallel Phase 2 trials in patients with
generalized anxiety disorder (GAD).

 

Seaport expects to initiate a Phase 2a proof-of pharmacology trial in the
second half of 2026. This randomized, double-blind trial of two dose levels
of GlyphAgo is designed to demonstrate proof-of-pharmacology by characterizing
the potential benefits of GlyphAgo on sleep, including objective measures of
sleep architecture, in patients with GAD and sleep disturbance. Topline data
from this trial are expected in early 2028.

 

Seaport also expects to initiate a Phase 2b trial of GlyphAgo in the first
half of 2027. This randomized, double-blind, placebo-controlled, potentially
registration-enabling trial is designed to evaluate the efficacy and safety of
GlyphAgo in patients with GAD. Topline data from this trial are expected by
the end of 2028.

 

The GlyphAgo program and the underlying Glyph platform were initially advanced
at PureTech, applying the Company's strategy of identifying clinically
validated pharmacology and overcoming key limitations through targeted
innovation. The Glyph platform and related programs are now being advanced by
PureTech's Founded Entity, Seaport Therapeutics.

 

The full text of the announcement from Seaport is as follows:

 

Seaport Therapeutics Reports Positive Multiple-Ascending Dose Data from Phase
1 Proof-of-Concept Trial of GlyphAgo™ in Healthy Volunteers

 

Repeat dosing of GlyphAgo confirms favorable safety, tolerability, and
pharmacokinetics observed across the Phase 1 program, with no liver-related
adverse events observed

 

New data demonstrate seven-day dosing of GlyphAgo achieved therapeutic
exposures of agomelatine at doses projected to avoid liver enzyme elevations
and reduce or eliminate the need for liver function testing

 

Results support dose selection and planned advancement into two parallel Phase
2 trials in patients with generalized anxiety disorder

 

BOSTON, June 8, 2026 -- Seaport Therapeutics, Inc.
(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.seaporttx.com%2F&esheet=54549166&newsitemid=20260608037260&lan=en-US&anchor=Seaport+Therapeutics%2C+Inc.&index=1&md5=8cbb23212c1494ecea495b9ad9ef0768)
, (Nasdaq: SPTX) ("Seaport" or the "Company"), a clinical-stage therapeutics
company that is inventing and developing novel neuropsychiatric medicines,
today announced positive data from the multiple-ascending dose (MAD) portion
of its Phase 1 proof-of-concept clinical trial evaluating repeat dosing of
GlyphAgo™ (SPT-320), a novel, Glyphed oral prodrug of agomelatine, in
healthy volunteers. Repeat dosing of GlyphAgo demonstrated a safety,
tolerability, and pharmacokinetic (PK) profile consistent with previously
reported
(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestors.seaporttx.com%2Fnews-releases%2Fnews-release-details%2Fseaport-therapeutics-announces-positive-proof-concept-topline&esheet=54549166&newsitemid=20260608037260&lan=en-US&anchor=previously+reported&index=2&md5=dcaae7ba92b2eb5380b5d03de6061554)
 single-ascending dose (SAD) and crossover data, supporting its planned
development in patients with generalized anxiety disorder (GAD).

 

The MAD data showed that seven-day dosing of GlyphAgo achieved therapeutic
exposures of agomelatine at doses that reduce liver exposure and are projected
to avoid liver enzyme elevations and reduce or eliminate the need for liver
function testing that has previously limited agomelatine's clinical use.
GlyphAgo AUC(0-24) and Cmax increased dose-dependently over the range of
doses studied, and agomelatine exposures following GlyphAgo administration in
the MAD portion were consistent with data from the SAD and crossover portions
of the trial. There was no unmodified agomelatine arm in the MAD portion.

 

Across all dose levels evaluated, GlyphAgo was well tolerated, with no serious
or severe adverse events, no liver-related adverse events, and no clinically
significant changes in liver-related laboratory parameters observed, further
supporting observations from the SAD and crossover cohorts.

 

"We are enthusiastic about the data from our Phase 1 program for GlyphAgo,
where we've now observed consistent safety, tolerability, and PK across all
cohorts," said Daphne Zohar, Co-Founder and Chief Executive Officer
of Seaport Therapeutics. "We believe these results substantially derisk our
future clinical development approach and strengthen the differentiated profile
of GlyphAgo. The complete Phase 1 data package further validates our Glyph
platform and supports the advancement of GlyphAgo into two parallel Phase 2
trials as we work to bring a new treatment option to patients with generalized
anxiety disorder who have not had a new medicine approved in almost 20 years."

 

The Phase 1 proof-of-concept trial, which included 174 participants, was
conducted in multiple parts to evaluate the safety, tolerability, and PK of
GlyphAgo and to compare the PK of GlyphAgo to agomelatine alone. The trial
included SAD and MAD cohorts, as well as a crossover portion (including both
food-effect and within-participant comparison between GlyphAgo and
agomelatine), using both open-label and placebo-controlled designs.

 

In the previously reported results from the head-to-head crossover portion of
the trial, GlyphAgo demonstrated a 6.8-fold increase in bioavailability of
agomelatine compared with orally administered unmodified agomelatine. GlyphAgo
also showed significantly lower (10-fold) PK variability compared to
unmodified agomelatine. The crossover portion included participants who were
taking estrogen-containing oral contraceptives that are known to increase
agomelatine exposure due to liver drug-drug interaction. In contrast, GlyphAgo
exposure was unaffected by oral contraceptives, further supporting the ability
of GlyphAgo to bypass first-pass liver metabolism. GlyphAgo demonstrated a 9.6
to 14.5-fold increase in dose-normalized exposure compared to agomelatine in a
separate SAD portion of the trial in which no participants were on oral
contraceptives.

 

Seaport expects to initiate a Phase 2a proof-of pharmacology trial in the
second half of 2026. This randomized, double-blind trial of two dose levels
of GlyphAgo is designed to demonstrate proof-of-pharmacology by characterizing
the potential benefits of GlyphAgo on sleep, including objective measures of
sleep architecture, in patients with GAD and sleep disturbance. Topline data
from this trial are expected in early 2028. Seaport also expects to initiate a
Phase 2b trial of GlyphAgo in the first half of 2027. This randomized,
double-blind, placebo-controlled, potentially registration-enabling trial is
designed to evaluate the efficacy and safety of GlyphAgo in patients with GAD.
Topline data from this trial are expected by the end of 2028. Seaport plans to
present additional analyses from the Phase 1 trial at future upcoming
scientific meetings.

 

About GlyphAgo(TM) (SPT-320 or Glyph Agomelatine)

GlyphAgo is a novel, "Glyphed" oral prodrug of agomelatine, a clinically
validated anti-anxiety and antidepressant that is approved for the treatment
of GAD in Australia and Major Depressive Disorder in Australia and
the European Union. Using Seaport's proprietary Glyph(TM) platform, GlyphAgo
is designed to enhance lymphatic absorption and avoid first-pass liver
metabolism, thereby enhancing oral bioavailability and reducing side effects.
By leveraging an alternative absorption pathway via the intestinal lymphatic
system used by dietary fats, GlyphAgo is designed to increase systemic
exposure of agomelatine, enabling exposure levels of agomelatine that are
effective in GAD but at a lower dose that reduces liver exposure and reduces
or eliminates the need for liver function testing. Based on the data generated
to date, Seaport believes GlyphAgo has the potential to become a leading
treatment for GAD.

 

About Seaport Therapeutics

Seaport Therapeutics (Nasdaq: SPTX) is a clinical-stage therapeutics company
focused on inventing and developing new medicines for patients with
depression, anxiety, and other debilitating neuropsychiatric disorders.
Through its differentiated approach, the Company identifies clinically
validated mechanisms with established efficacy and safety which had
historically been limited by high first-pass metabolism, low bioavailability,
and/or side effects. Seaport applies its proprietary Glyph(TM) platform to
overcome those limitations and invent innovative oral therapies. With an
experienced team of industry leaders, Seaport has a proven track record in
neuropsychiatry drug discovery and development and delivering successful
business outcomes. Seaport aims to develop novel, leading treatment options
that will make a significant impact for patients and their families. For more
information, please visit www.seaporttx.com
(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.seaporttx.com%2F&esheet=54549166&newsitemid=20260608037260&lan=en-US&anchor=www.seaporttx.com&index=3&md5=4b65ca3e7d3caa31c96ed1fbae6482e1)
.

 

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934, each as amended. The words "anticipate," "believe,"
"continue," "could," "estimate," "expect," "intend," "may," "plan,"
"potential," "predict," "project," "should," "target," "would" and similar
expressions are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words. These
forward-looking statements include, but are not limited to, express or implied
statements regarding our product candidates, preclinical and clinical
development activities and timelines, including projected data announcements,
and our expectations for future operations and financial performance. These
statements include, among other things, Seaport Therapeutics' expectations
regarding the concurrent Phase 2 trials of GlyphAgo (SPT-320), including the
expected trial design and the timing of topline data.

 

Forward-looking statements are based on management's current expectations and
are subject to risks and uncertainties that could negatively affect Seaport
Therapeutics' business, operating results, financial condition and stock
value. Factors that could cause actual results to differ materially from those
currently anticipated include: risks relating to the Company's research and
development activities; Seaport Therapeutics' ability to execute on its
strategy including obtaining the requisite regulatory approvals on the
expected timeline, if at all; uncertainties relating to preclinical and
clinical development activities; the Company's dependence on third parties to
conduct clinical trials, manufacture its product candidates and develop and
commercialize its product candidates, if approved; Seaport Therapeutics'
ability to attract, integrate and retain key personnel; risks related to the
Company's financial condition and need for substantial additional funds in
order to complete development activities and commercialize a product
candidate, if approved; risks related to regulatory developments and approval
processes of the U.S. Food and Drug Administration and comparable foreign
regulatory authorities; risks related to establishing and maintaining Seaport
Therapeutics' intellectual property protections; and risks related to the
competitive landscape for Seaport Therapeutics' product candidates; as well as
other risks described in "Risk Factors," in Seaport Therapeutics' Registration
Statement on Form S-1 filed with the Securities and Exchange Commission (SEC),
as well as subsequent filings with the SEC. Seaport Therapeutics expressly
disclaims any obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to reflect any
change in its expectations or any changes in events, conditions or
circumstances on which any such statement is based, except as required by law,
and claims the protection of the safe harbor for forward-looking statements
contained in the Private Securities Litigation Reform Act of 1995.

 

Seaport uses and intends to continue to use its Investor Relations website as
a means of disclosing material nonpublic information and for complying with
its disclosure obligations under Regulation FD. Accordingly, investors should
monitor the Company's Investor Relations website, in addition to following the
Company's press releases, SEC filings, public conference calls, presentations,
and webcasts.

 

About PureTech Health

PureTech Health is a hub-and-spoke biotherapeutics company dedicated to giving
life to science and transforming innovation into value. We do this through a
proven, capital-efficient R&D model focused on opportunities with
validated pharmacology and untapped potential to address significant patient
needs. This strategy has produced dozens of therapeutic candidates, including
three that have received U.S. FDA approval. By identifying, shaping, and
de-risking these high-conviction assets, and scaling them through dedicated
structures backed by external capital, we accelerate their path to patients
while creating sustainable value for shareholders.

 

For more information, visit www.puretechhealth.com or connect with us on
LinkedIn (https://www.linkedin.com/company/puretech-health/) and 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 those related to Seaport's
development plans for its pipeline of neuropsychiatric therapeutics based on
the Glyph™ Platform, the potential of GlyphAgo(TM) (SPT-320(TM) or Glyph
Agomelatine) and the Glyph platform, the broader applicability of the
platform, the addressable market for Seaport's product candidates, if
approved, 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, 2025, 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
jchen@tenbridgecommunications.com (mailto:jchen@tenbridgecommunications.com)

 

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