Latest news with #PureTechHealth
Yahoo
11 hours ago
- Business
- Yahoo
PureTech forms respiratory spin-off Celea to advance deuterated pirfenidone
US-based PureTech Health has launched Celea Therapeutics, a new respiratory disease-focused biotherapeutics spin-off, to make efficient use of its capital. Led by former Teva CEO Sven Dethlefs, the newly founded subsidiary will take over the late-stage clinical development of PureTech's Phase III-ready lead asset, deupirfenidone (LYT-100) in idiopathic pulmonary fibrosis (IPF). Though the oral drug is currently only being trialled in IPF, Celea Therapeutics will pursue its development in 'multiple fibrotic and inflammatory lung conditions', PureTech said in a statement. Deupirfenidone is a deuterated form of Roche-owned Genentech's star IPF drug Esbriet (pirfenidone) – the first treatment to gain FDA approval for this indication in 2014. Originally developed by deuteration technology pioneer Auspex Pharmaceuticals, deupirfenidone is designed to overcome the current efficacy challenges posed by Esbriet, which largely stem from the drug's toxicity at high doses. By substituting three hydrogen atoms on Esbriet's structure with deuterium, deupirfenidone has already demonstrated a favourable tolerability profile in the Phase IIb ELEVATE trial (NCT05321420), while stabilising lung function decline over 26 weeks. PureTech plans to discuss the Phase IIb results with the FDA by the end of Q3 with the intention of initiating a Phase III trial at the end of 2025, the company said in a 20 May statement. IPF market to broaden Up until recently, the IPF market has primarily revolved around the use of Esbriet and its only major competitor, Ofev (nintedanib), which was commercialised in 2014. Produced by Boehringer Ingelheim, Ofev is a tyrosine kinase inhibitor (TKI) which works to prevent lung scarring. According to GlobalData's Intelligence Center, the drug made just over $4bn in sales in 2024. GlobalData is the parent company of Pharmaceutical Technology. To keep up its momentum in this market, Boehringer is aiming to commercialise a follow-on to Ofev in this indication, nerandomalist, which is expected to be FDA-approved for IPF by the Q4 2025 following positive Phase III trial readouts. EmphyCorp's nasally administered antioxidant spray N-115 (sodium pyruvate) is also in the pre-registration phase for this IPF, with a GlobalData report revealing that drugs in this stage have a 100% transition success rate within the indication. The FDA's decision is expected by September 2025. Though Ofev, nerandomalist, N-115 and Esbriet would be in direct competition with deupirfenidone if it were to be approved, PureHealth would likely see more competition from Boehringer and EmphyCorp's therapies. This is due to the erosion of Esbriet's market value through its 2022 patent expiry, which caused the drug's sales to drop from $1.1bn in 2021 to $107m in 2024. Generics of Esbriet have already been approved and launched, including by Sandoz, Accord Healthcare, Amneal, and Teva. "PureTech forms respiratory spin-off Celea to advance deuterated pirfenidone" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
27-07-2025
- Business
- Yahoo
With 71% ownership of the shares, PureTech Health plc (LON:PRTC) is heavily dominated by institutional owners
Key Insights Institutions' substantial holdings in PureTech Health implies that they have significant influence over the company's share price A total of 11 investors have a majority stake in the company with 51% ownership Past performance of a company along with ownership data serve to give a strong idea about prospects for a business Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. Every investor in PureTech Health plc (LON:PRTC) should be aware of the most powerful shareholder groups. With 71% stake, institutions possess the maximum shares in the company. That is, the group stands to benefit the most if the stock rises (or lose the most if there is a downturn). Since institutional have access to huge amounts of capital, their market moves tend to receive a lot of scrutiny by retail or individual investors. Therefore, a good portion of institutional money invested in the company is usually a huge vote of confidence on its future. Let's take a closer look to see what the different types of shareholders can tell us about PureTech Health. See our latest analysis for PureTech Health What Does The Institutional Ownership Tell Us About PureTech Health? Institutions typically measure themselves against a benchmark when reporting to their own investors, so they often become more enthusiastic about a stock once it's included in a major index. We would expect most companies to have some institutions on the register, especially if they are growing. We can see that PureTech Health does have institutional investors; and they hold a good portion of the company's stock. This can indicate that the company has a certain degree of credibility in the investment community. However, it is best to be wary of relying on the supposed validation that comes with institutional investors. They too, get it wrong sometimes. When multiple institutions own a stock, there's always a risk that they are in a 'crowded trade'. When such a trade goes wrong, multiple parties may compete to sell stock fast. This risk is higher in a company without a history of growth. You can see PureTech Health's historic earnings and revenue below, but keep in mind there's always more to the story. Institutional investors own over 50% of the company, so together than can probably strongly influence board decisions. It looks like hedge funds own 5.2% of PureTech Health shares. That's interesting, because hedge funds can be quite active and activist. Many look for medium term catalysts that will drive the share price higher. Looking at our data, we can see that the largest shareholder is Invesco Ltd. with 17% of shares outstanding. For context, the second largest shareholder holds about 5.6% of the shares outstanding, followed by an ownership of 5.2% by the third-largest shareholder. After doing some more digging, we found that the top 11 have the combined ownership of 51% in the company, suggesting that no single shareholder has significant control over the company. Researching institutional ownership is a good way to gauge and filter a stock's expected performance. The same can be achieved by studying analyst sentiments. There is a little analyst coverage of the stock, but not much. So there is room for it to gain more coverage. Insider Ownership Of PureTech Health The definition of an insider can differ slightly between different countries, but members of the board of directors always count. Company management run the business, but the CEO will answer to the board, even if he or she is a member of it. I generally consider insider ownership to be a good thing. However, on some occasions it makes it more difficult for other shareholders to hold the board accountable for decisions. Our most recent data indicates that insiders own some shares in PureTech Health plc. It has a market capitalization of just UK£344m, and insiders have UK£16m worth of shares, in their own names. It is good to see some investment by insiders, but it might be worth checking if those insiders have been buying. General Public Ownership The general public-- including retail investors -- own 15% stake in the company, and hence can't easily be ignored. While this group can't necessarily call the shots, it can certainly have a real influence on how the company is run. Public Company Ownership It appears to us that public companies own 4.0% of PureTech Health. We can't be certain but it is quite possible this is a strategic stake. The businesses may be similar, or work together. Next Steps: It's always worth thinking about the different groups who own shares in a company. But to understand PureTech Health better, we need to consider many other factors. Like risks, for instance. Every company has them, and we've spotted 3 warning signs for PureTech Health (of which 2 make us uncomfortable!) you should know about. If you are like me, you may want to think about whether this company will grow or shrink. Luckily, you can check this free report showing analyst forecasts for its future. NB: Figures in this article are calculated using data from the last twelve months, which refer to the 12-month period ending on the last date of the month the financial statement is dated. This may not be consistent with full year annual report figures. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Yahoo
27-07-2025
- Business
- Yahoo
With 71% ownership of the shares, PureTech Health plc (LON:PRTC) is heavily dominated by institutional owners
Key Insights Institutions' substantial holdings in PureTech Health implies that they have significant influence over the company's share price A total of 11 investors have a majority stake in the company with 51% ownership Past performance of a company along with ownership data serve to give a strong idea about prospects for a business Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. Every investor in PureTech Health plc (LON:PRTC) should be aware of the most powerful shareholder groups. With 71% stake, institutions possess the maximum shares in the company. That is, the group stands to benefit the most if the stock rises (or lose the most if there is a downturn). Since institutional have access to huge amounts of capital, their market moves tend to receive a lot of scrutiny by retail or individual investors. Therefore, a good portion of institutional money invested in the company is usually a huge vote of confidence on its future. Let's take a closer look to see what the different types of shareholders can tell us about PureTech Health. See our latest analysis for PureTech Health What Does The Institutional Ownership Tell Us About PureTech Health? Institutions typically measure themselves against a benchmark when reporting to their own investors, so they often become more enthusiastic about a stock once it's included in a major index. We would expect most companies to have some institutions on the register, especially if they are growing. We can see that PureTech Health does have institutional investors; and they hold a good portion of the company's stock. This can indicate that the company has a certain degree of credibility in the investment community. However, it is best to be wary of relying on the supposed validation that comes with institutional investors. They too, get it wrong sometimes. When multiple institutions own a stock, there's always a risk that they are in a 'crowded trade'. When such a trade goes wrong, multiple parties may compete to sell stock fast. This risk is higher in a company without a history of growth. You can see PureTech Health's historic earnings and revenue below, but keep in mind there's always more to the story. Institutional investors own over 50% of the company, so together than can probably strongly influence board decisions. It looks like hedge funds own 5.2% of PureTech Health shares. That's interesting, because hedge funds can be quite active and activist. Many look for medium term catalysts that will drive the share price higher. Looking at our data, we can see that the largest shareholder is Invesco Ltd. with 17% of shares outstanding. For context, the second largest shareholder holds about 5.6% of the shares outstanding, followed by an ownership of 5.2% by the third-largest shareholder. After doing some more digging, we found that the top 11 have the combined ownership of 51% in the company, suggesting that no single shareholder has significant control over the company. Researching institutional ownership is a good way to gauge and filter a stock's expected performance. The same can be achieved by studying analyst sentiments. There is a little analyst coverage of the stock, but not much. So there is room for it to gain more coverage. Insider Ownership Of PureTech Health The definition of an insider can differ slightly between different countries, but members of the board of directors always count. Company management run the business, but the CEO will answer to the board, even if he or she is a member of it. I generally consider insider ownership to be a good thing. However, on some occasions it makes it more difficult for other shareholders to hold the board accountable for decisions. Our most recent data indicates that insiders own some shares in PureTech Health plc. It has a market capitalization of just UK£344m, and insiders have UK£16m worth of shares, in their own names. It is good to see some investment by insiders, but it might be worth checking if those insiders have been buying. General Public Ownership The general public-- including retail investors -- own 15% stake in the company, and hence can't easily be ignored. While this group can't necessarily call the shots, it can certainly have a real influence on how the company is run. Public Company Ownership It appears to us that public companies own 4.0% of PureTech Health. We can't be certain but it is quite possible this is a strategic stake. The businesses may be similar, or work together. Next Steps: It's always worth thinking about the different groups who own shares in a company. But to understand PureTech Health better, we need to consider many other factors. Like risks, for instance. Every company has them, and we've spotted 3 warning signs for PureTech Health (of which 2 make us uncomfortable!) you should know about. If you are like me, you may want to think about whether this company will grow or shrink. Luckily, you can check this free report showing analyst forecasts for its future. NB: Figures in this article are calculated using data from the last twelve months, which refer to the 12-month period ending on the last date of the month the financial statement is dated. This may not be consistent with full year annual report figures. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Globe and Mail
17-07-2025
- Business
- Globe and Mail
PureTech Founded Entity Seaport Therapeutics Announces First Patient Dosed in Phase 2b BUOY-1 Study of GlyphAllo™ (SPT-300) in Major Depressive Disorder (MDD), With or Without Anxious Distress
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech"), 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 that the first patient has been dosed in the Phase 2b BUOY-1 study of GlyphAllo™ SPT-300 or Glyph Allopregnanolone) in major depressive disorder (MDD) with or without anxious distress. GlyphAllo is a novel, 'Glyphed' oral prodrug of allopregnanolone, an endogenous molecule that has been shown to dampen stress. Allopregnanolone has been clinically validated in third-party trials as a rapidly acting antidepressant with anxiolytic effects, but its scope of clinical use was previously constrained by limitations that the Glyph™ platform is specifically designed to solve. GlyphAllo has the potential to be a first-in-class treatment for patients with MDD, including those with or without anxious distress. The full text of the announcement from Seaport is as follows: Seaport Therapeutics Announces First Patient Dosed in Phase 2b BUOY-1 Study of GlyphAllo ™ (SPT-300) in Major Depressive Disorder (MDD), With or Without Anxious Distress BUOY-1 builds on successful Phase 1 and Phase 2a data with GlyphAllo – a novel oral prodrug of allopregnanolone and a potential first-in-class treatment for MDD Allopregnanolone has demonstrated rapid antidepressant and anxiolytic activity in clinical settings, but its clinical scope was previously constrained by limitations that Glyph™ is specifically designed to solve Boston, MA – July 17, 2025 – 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 that the first patient has been dosed in the Phase 2b BUOY-1 study of GlyphAllo™ (SPT-300 or Glyph Allopregnanolone) in major depressive disorder (MDD) with or without anxious distress. GlyphAllo is a novel, 'Glyphed' oral prodrug of allopregnanolone, an endogenous molecule that has been shown to dampen stress. Allopregnanolone has been clinically validated in third-party trials as a rapidly acting antidepressant with anxiolytic effects, but its scope of clinical use was previously constrained by limitations that the Glyph™ platform is specifically designed to solve. GlyphAllo has the potential to be a first-in-class treatment for patients with MDD, including those with or without anxious distress. 'The initiation of BUOY-1 marks a significant milestone for Seaport's pipeline, bringing us closer to a potential new treatment for major depression, which impacts around 280 million people globally – nearly 60 percent of whom also experience anxious distress,' said Daphne Zohar, Co-Founder and Chief Executive Officer at Seaport Therapeutics. 'This is an important step on our journey to deliver new treatments for patients living with depression, anxiety, and other neuropsychiatric conditions.' BUOY-1 is a global, randomized, double-blind, placebo-controlled study that will evaluate the efficacy, safety, and tolerability of GlyphAllo in adults with MDD, with or without anxious distress, a subtype of depression characterized by significant anxiety. The study is expected to enroll up to approximately 360 patients, randomized 1:1 to receive either GlyphAllo or placebo once-daily over a six-week treatment period. The primary endpoint of the study is the change from baseline at six weeks in the Hamilton Depression Rating Scale-17 (HAM-D-17), a gold-standard depression severity rating scale. Following the initial treatment period, eligible patients may enter an open-label extension phase, during which all participants will receive GlyphAllo for up to an additional six weeks. 'CNS clinical trials are inherently complex, and we are applying our team's extensive expertise to implement a high-quality study,' said Antony Loebel, M.D., Chief Medical Officer, President of Clinical Development at Seaport Therapeutics. 'We are confident that our rigorous clinical trial execution, including an emphasis on the quality of patient enrollment, will build on a proven mechanism and established clinical efficacy, to increase our likelihood of success in developing an effective treatment for patients with depression." The BUOY-1 study builds on a foundation of positive clinical data from Phase 1 and Phase 2a studies of GlyphAllo in healthy volunteers. In Phase 1, GlyphAllo demonstrated approximately nine times greater allopregnanolone exposure than that previously reported following oral dosing of allopregnanolone and reached similar exposures to the efficacious doses of IV-infused allopregnanolone. The two key measures used to determine allopregnanolone-associated brain activity, EEG beta frequency power and reduction in saccadic eye velocity, confirmed that GlyphAllo engaged with its target in a dose-dependent manner. The overall safety data, pharmacokinetics, and pharmacodynamic findings, along with non-clinical studies, support six-week dosing of GlyphAllo in BUOY-1. In a Phase 2a proof-of-concept study in healthy volunteers using the Trier Social Stress Test (TSST), a validated clinical model of anxiety, GlyphAllo significantly reduced the stress hormone salivary cortisol at all post-TSST timepoints compared to placebo, meeting the primary endpoint with a p-value of 0.0001 and demonstrating that GlyphAllo regulates hypothalamic-pituitary-adrenal axis reactivity to acute stress. GlyphAllo was generally well-tolerated, with adverse events that were mostly mild and transient. About the Glyph ™ 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. The Glyph platform has the potential to be widely applied to many therapeutic molecules that have high first-pass metabolism otherwise leading to low bioavailability and/or side effects, including liver enzyme elevations or hepatotoxicity. For each program, Seaport leverages its Glyph platform to create unique sets of prodrugs with differentiated profiles, including lymphatic transport and conversion characteristics, as potential candidates to advance into preclinical and clinical proof-of-concept studies. Seaport exclusively licensed this technology from Monash University based on the pioneering research of the Porter Research Group. Advanced initially at PureTech Health and now at Seaport, Glyph has been applied to create therapeutic candidates for the Company's pipeline resulting in new intellectual property, including composition of matter. The group and its collaborators have published research in Nature Metabolism, Frontiers in Pharmacology, Journal of Controlled Release and Molecular Pharmaceutics supporting the Glyph platform's capabilities. See Glyph in action here. About GlyphAllo™ (SPT-300 or Glyph Allopregnanolone) GlyphAllo (SPT-300 or Glyph Allopregnanolone), an oral prodrug of allopregnanolone, is in clinical stage development for the treatment of major depressive disorder (MDD) with or without anxious distress. Allopregnanolone, an endogenous molecule that has been shown to dampen stress, has antidepressant and anxiolytic activity and sleep-promoting effects but poor oral bioavailability due to substantial first-pass hepatic metabolism. Allopregnanolone was previously only approved as an intravenous infusion, which limited the scope of its clinical use. A synthetic analog of allopregnanolone was previously evaluated in MDD and showed promise but may not retain the activity, potency and the breadth of the natural biological response of endogenous allopregnanolone. In a Phase 1 clinical study, GlyphAllo demonstrated oral bioavailability, tolerability and γ-aminobutyric-acid type A (GABA A) receptor target engagement in healthy volunteers. In a Phase 2a clinical study, GlyphAllo demonstrated initial proof-of-concept in the Trier Social Stress Test, a validated clinical model of anxiety in healthy volunteers. GlyphAllo is currently being evaluated in the Phase 2b BUOY-1 study for MDD, with or without anxious distress. 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 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 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 portfolio 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 portfolio of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points. For more information, visit 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 neuropsychiatric therapeutics based on the Glyph™ Platform, the potential of GlyphAllo™ and the Glyph™ platform, the design and expected safety and efficacy outcomes of the BUOY-1 study, 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, 2024, 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.
Associated Press
17-07-2025
- Business
- Associated Press
PureTech Founded Entity Seaport Therapeutics Announces First Patient Dosed in Phase 2b BUOY-1 Study of GlyphAllo™ (SPT-300) in Major Depressive Disorder (MDD), With or Without Anxious Distress
BOSTON--(BUSINESS WIRE)--Jul 17, 2025-- PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ('PureTech'), 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 that the first patient has been dosed in the Phase 2b BUOY-1 study of GlyphAllo™ SPT-300 or Glyph Allopregnanolone) in major depressive disorder (MDD) with or without anxious distress. GlyphAllo is a novel, 'Glyphed' oral prodrug of allopregnanolone, an endogenous molecule that has been shown to dampen stress. Allopregnanolone has been clinically validated in third-party trials as a rapidly acting antidepressant with anxiolytic effects, but its scope of clinical use was previously constrained by limitations that the Glyph™ platform is specifically designed to solve. GlyphAllo has the potential to be a first-in-class treatment for patients with MDD, including those with or without anxious distress. The full text of the announcement from Seaport is as follows: Seaport Therapeutics Announces First Patient Dosed in Phase 2b BUOY-1 Study of GlyphAllo™(SPT-300) in Major Depressive Disorder (MDD), With or Without Anxious Distress BUOY-1 builds on successful Phase 1 and Phase 2a data with GlyphAllo – a novel oral prodrug of allopregnanolone and a potential first-in-class treatment for MDD Allopregnanolone has demonstrated rapid antidepressant and anxiolytic activity in clinical settings, but its clinical scope was previously constrained by limitations that Glyph™ is specifically designed to solve Boston, MA – July 17, 2025 – 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 that the first patient has been dosed in the Phase 2b BUOY-1 study of GlyphAllo™ (SPT-300 or Glyph Allopregnanolone) in major depressive disorder (MDD) with or without anxious distress. GlyphAllo is a novel, 'Glyphed' oral prodrug of allopregnanolone, an endogenous molecule that has been shown to dampen stress. Allopregnanolone has been clinically validated in third-party trials as a rapidly acting antidepressant with anxiolytic effects, but its scope of clinical use was previously constrained by limitations that the Glyph™ platform is specifically designed to solve. GlyphAllo has the potential to be a first-in-class treatment for patients with MDD, including those with or without anxious distress. 'The initiation of BUOY-1 marks a significant milestone for Seaport's pipeline, bringing us closer to a potential new treatment for major depression, which impacts around 280 million people globally – nearly 60 percent of whom also experience anxious distress,' said Daphne Zohar, Co-Founder and Chief Executive Officer at Seaport Therapeutics. 'This is an important step on our journey to deliver new treatments for patients living with depression, anxiety, and other neuropsychiatric conditions.' BUOY-1 is a global, randomized, double-blind, placebo-controlled study that will evaluate the efficacy, safety, and tolerability of GlyphAllo in adults with MDD, with or without anxious distress, a subtype of depression characterized by significant anxiety. The study is expected to enroll up to approximately 360 patients, randomized 1:1 to receive either GlyphAllo or placebo once-daily over a six-week treatment period. The primary endpoint of the study is the change from baseline at six weeks in the Hamilton Depression Rating Scale-17 (HAM-D-17), a gold-standard depression severity rating scale. Following the initial treatment period, eligible patients may enter an open-label extension phase, during which all participants will receive GlyphAllo for up to an additional six weeks. 'CNS clinical trials are inherently complex, and we are applying our team's extensive expertise to implement a high-quality study,' said Antony Loebel, M.D., Chief Medical Officer, President of Clinical Development at Seaport Therapeutics. 'We are confident that our rigorous clinical trial execution, including an emphasis on the quality of patient enrollment, will build on a proven mechanism and established clinical efficacy, to increase our likelihood of success in developing an effective treatment for patients with depression.' The BUOY-1 study builds on a foundation of positive clinical data from Phase 1 and Phase 2a studies of GlyphAllo in healthy volunteers. In Phase 1, GlyphAllo demonstrated approximately nine times greater allopregnanolone exposure than that previously reported following oral dosing of allopregnanolone and reached similar exposures to the efficacious doses of IV-infused allopregnanolone. The two key measures used to determine allopregnanolone-associated brain activity, EEG beta frequency power and reduction in saccadic eye velocity, confirmed that GlyphAllo engaged with its target in a dose-dependent manner. The overall safety data, pharmacokinetics, and pharmacodynamic findings, along with non-clinical studies, support six-week dosing of GlyphAllo in BUOY-1. In a Phase 2a proof-of-concept study in healthy volunteers using the Trier Social Stress Test (TSST), a validated clinical model of anxiety, GlyphAllo significantly reduced the stress hormone salivary cortisol at all post-TSST timepoints compared to placebo, meeting the primary endpoint with a p-value of 0.0001 and demonstrating that GlyphAllo regulates hypothalamic-pituitary-adrenal axis reactivity to acute stress. GlyphAllo was generally well-tolerated, with adverse events that were mostly mild and transient. For more information, visit or connect with us on X (formerly Twitter) @puretechh. Rosellini, A., et al (2018). Anxious distress in depressed outpatients: Prevalence, comorbidity, and incremental validity. View source version on CONTACT: PureTech Public Relations [email protected] Investor Relations [email protected]/EU Media Ben Atwell, Rob Winder +44 (0) 20 3727 1000 [email protected] Media Justin Chen +1 609 578 7230 [email protected] KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS INDUSTRY KEYWORD: BIOTECHNOLOGY FDA HEALTH GENERAL HEALTH PHARMACEUTICAL NEUROLOGY MENTAL HEALTH HEALTH TECHNOLOGY RESEARCH SCIENCE CLINICAL TRIALS SOURCE: PureTech Health plc Copyright Business Wire 2025. PUB: 07/17/2025 07:05 AM/DISC: 07/17/2025 07:05 AM
