\nGlyphAgo is a novel, \u201cGlyphed\u201d oral prodrug of agomelatine designed to enhance lymphatic absorption and bypass first-pass liver metabolism. In the Phase 1 program, GlyphAgo demonstrated a statistically significant 6.8-fold increase in bioavailability of agomelatine compared to unmodified agomelatine and showed significantly lower (10-fold) PK variability. GlyphAgo achieved therapeutically relevant exposure of agomelatine at substantially lower doses that are designed to reduce liver exposure. Seaport believes this approach has the potential to reduce the risk of liver enzyme elevations and reduce the need for routine liver function monitoring that has historically limited agomelatine\u2019s clinical use.<\/p>\n
\nSeaport has initiated a Phase 2a clinical trial evaluating GlyphAgo in adults with generalized anxiety disorder and sleep disturbance, with topline results expected in early 2028. Seaport also plans to initiate a Phase 2\/3 clinical trial evaluating the efficacy and safety of GlyphAgo in patients with generalized anxiety disorder in the first half of 2027.<\/p>\n
\nThe full text of the announcement from Seaport is as follows:<\/p>\n
Seaport Therapeutics Presents Additional Pharmacokinetic Data from Phase 1 Clinical Trial of GlyphAgo\u2122 at the 39th European College of Neuropsychopharmacology (ECNP) Congress<\/b><\/p>\n
First scientific presentation of detailed PK data demonstrates dose-dependent increases in agomelatine exposure, no food effect, and no accumulation of exposure over seven days of dosing<\/i><\/p>\n
Detailed data reinforces previously reported topline results demonstrating that GlyphAgo achieved a statistically significant 6.8-fold increase in agomelatine bioavailability and substantially lower (10-fold) PK variability compared to unmodified agomelatine<\/i><\/p>\n
Agomelatine levels comparable to those seen with efficacious doses of the unmodified drug were achieved at substantially lower doses, intended to reduce hepatic exposure and the potential for liver enzyme elevations<\/i><\/p>\n
\nBOSTON–Oct. 9, 2026– Seaport Therapeutics, Inc.<\/a> (Nasdaq: SPTX) (\u201cSeaport\u201d or the \u201cCompany\u201d), a clinical-stage therapeutics company developing novel neuropsychiatric medicines, today announced the presentation of Phase 1 clinical data for GlyphAgo\u2122 (SPT-320 or Glyph Agomelatine) at the 39th European College of Neuropsychopharmacology (ECNP) Congress, taking place October 10-13, 2026, in Munich, Germany. The poster represents the first scientific presentation of data from the GlyphAgo Phase 1 program and provides detailed pharmacokinetic (PK) analyses supporting previously reported topline results and reinforcing GlyphAgo’s differentiated profile.<\/p>\n \nGlyphAgo is a novel, \u201cGlyphed\u201d oral prodrug of agomelatine designed to enhance lymphatic absorption and bypass first-pass liver metabolism. In the Phase 1 program, GlyphAgo demonstrated a statistically significant 6.8-fold increase in bioavailability of agomelatine compared to unmodified agomelatine and showed significantly lower (10-fold) PK variability. GlyphAgo achieved therapeutically relevant exposure of agomelatine at substantially lower doses that are designed to reduce liver exposure. Seaport believes this approach has the potential to reduce the risk of liver enzyme elevations and reduce the need for routine liver function monitoring that has historically limited agomelatine\u2019s clinical use.<\/p>\n \n\u201cThe data presented at ECNP provide important clinical validation that our Glyph\u2122 platform can meaningfully improve the pharmacokinetic profile of medicines historically limited by high first-pass liver metabolism,\u201d said Daniel Bonner, Ph.D., Co-Founder and Senior Vice President, Platform, at Seaport Therapeutics. \u201cThe increased exposure and markedly reduced inter-individual variability observed in the Phase 1 program are particularly compelling. More predictable drug exposure may translate into more consistent clinical outcomes for patients, further supporting the development of GlyphAgo as a potential treatment for generalized anxiety disorder.\u201d<\/p>\n \nThe completed multi-part Phase 1 proof-of-concept trial evaluated the safety, tolerability and pharmacokinetics of GlyphAgo in 174 healthy volunteers. The newly presented results include data from the multiple-ascending dose (MAD) portion and analyses supporting the absence of a food effect with GlyphAgo. The single- and multiple-ascending dose portions of the trial demonstrated dose-dependent increases in agomelatine exposure and showed no accumulation of exposure over seven days of dosing, supporting a consistent profile with repeat dosing. Additional analyses presented in the poster further characterize the substantially reduced PK variability observed with GlyphAgo, with variability in both AUC\u2080-\u2082\u2084 and Cmax substantially lower than with unmodified agomelatine. Specifically, in the SAD portion, PK variability (geometric CV%) observed in participants dosed with GlyphAgo ranged from 12.9% to 26.6% for AUC\u2080-\u2082\u2084 and from 17.1% to 50.5% for Cmax, compared with 200% and 217%, respectively, for unmodified agomelatine. In the crossover portion, PK variability in participants dosed with GlyphAgo ranged from 22.6% to 29.7% for AUC\u2080-\u2082\u2084 and from 26.5% to 44.0% for Cmax, compared with ranges of 234.6% to 350.1% and 303.7% to 500.9%, respectively, for unmodified agomelatine. As previously noted, the data showed no effect of estrogen-containing oral contraceptives on agomelatine exposure following GlyphAgo dosing, further supporting the ability of GlyphAgo to bypass first-pass hepatic metabolism and avoid drug-drug interactions that occur in the liver.<\/p>\n Details of the presentation are as follows:<\/b><\/p>\n \nSeaport has initiated a Phase 2a clinical trial evaluating GlyphAgo in adults with generalized anxiety disorder and sleep disturbance, with topline results expected in early 2028. The Company also plans to initiate a Phase 2\/3 clinical trial evaluating the efficacy and safety of GlyphAgo in patients with GAD in the first half of 2027.<\/p>\n About GlyphAgo<\/b>\u2122<\/b> (SPT-320 or Glyph Agomelatine)<\/b><\/p>\n \nGlyphAgo is a novel, \u201cGlyphed\u201d 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\u2019s proprietary Glyph\u2122 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 within the range observed to be effective in third-party placebo-controlled studies in GAD but at a lower dose that is designed to reduce liver exposure. Based on the data generated to date, Seaport believes GlyphAgo has the potential to become a leading treatment for GAD.<\/p>\n About Seaport Therapeutics<\/b><\/p>\n \nSeaport 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\u2122 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<\/a>.<\/p>\n Forward-Looking Statements<\/b><\/p>\n \nThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccontemplate,\u201d \u201ccontinue,\u201d \u201ccould,\u201d \u201cdesign,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201cseek,\u201d \u201cshould,\u201d \u201ctarget,\u201d \u201cwould,\u201d \u201cwill\u201d 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, including: the therapeutic potential of GlyphAgo, including its potential to achieve therapeutic exposures of agomelatine at lower doses, reduce liver exposure, and reduce or eliminate the need for liver function testing; the design and previously reported topline results of the Phase 1 trial of GlyphAgo; the design, progress, enrollment and results of the Phase 2a trial of GlyphAgo and the anticipated timing of topline data in early 2028; and the planned initiation of the Phase 2\/3 trial of GlyphAgo in the first half of 2027 and the anticipated timing of topline data by the end of 2028.<\/p>\n \nForward-looking statements are based on management\u2019s current expectations and are subject to risks and uncertainties that could negatively affect Seaport\u2019s 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\u2019s research and development activities, including with respect to the GlyphAgo Phase 2a trial and planned Phase 2\/3 trial; risks that results from earlier trials, including the Phase 1 trial of GlyphAgo, or from third-party trials of agomelatine may not be predictive of future results, including with respect to liver safety; Seaport\u2019s ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to Seaport\u2019s preclinical and clinical development activities; the Company\u2019s dependence on third parties to conduct clinical trials, manufacture its product candidates and develop and commercialize its product candidates, if approved; Seaport\u2019s ability to attract, integrate and retain key personnel; risks related to the Company\u2019s financial condition, including Seaport\u2019s limited operating history and history of significant losses, its need for substantial additional funding and its ability to raise capital when needed, on acceptable terms, or at all, 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\u2019s intellectual property protections; and risks related to the competitive landscape for Seaport\u2019s product candidates; as well as other risks and uncertainties described in \u201cRisk Factors,\u201d in Seaport\u2019s Quarterly Report on Form 10-Q for the three months ended June 30, 2026 filed with the Securities and Exchange Commission (\u201cSEC\u201d), as well as in subsequent filings with the SEC. Seaport 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.<\/p>\n \nSeaport 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\u2019s Investor Relations website, in addition to following the Company\u2019s press releases, SEC filings, public conference calls, presentations, and webcasts.<\/p>\n About PureTech Health<\/b><\/p>\n \nPureTech 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.<\/p>\n \nFor more information, visit www.puretechhealth.com<\/a> or connect with us on LinkedIn<\/a> and X (formerly Twitter) @puretechh.<\/p>\n Cautionary Note Regarding Forward-Looking Statements<\/strong><\/p>\n \nThis 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 neuropsychiatric therapeutics based on the Glyph\u2122 Platform, the potential of GlyphAgo\u2122 (SPT-320 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.<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20261009968454\/en\/<\/a><\/span><\/p>\n PureTech KEYWORDS:<\/b> United States North America Massachusetts<\/p>\n INDUSTRY KEYWORDS:<\/b> Science Neurology Biotechnology Research Pharmaceutical Health Mental Health Clinical Trials<\/p>\n\n
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