Latest news with #MajorDepressiveDisorder
Sinar Daily
2 days ago
- Sinar Daily
Former private college student jailed three months, fined RM10,000 for infanticide
The 23-year-old woman to serve the jail sentence from the date of her arrest, taking into account the periods she had already been detained, from July 10 to Sept 14, 2020 and from Dec 30, 2020, to Jan 15, 2021. 08 Aug 2025 03:40pm A former private college student was sentenced by the High Court today to three months' imprisonment and fined RM10,000, in default five months in jail, after pleading guilty to an alternative charge of infanticide. GEORGE TOWN - A former private college student was sentenced by the High Court here today to three months' imprisonment and fined RM10,000, in default five months in jail, after pleading guilty to an alternative charge of infanticide. Judge Rofiah Mohamad ordered the 23-year-old woman to serve the jail sentence from the date of her arrest, taking into account the periods she had already been detained, from July 10 to Sept 14, 2020, and from Dec 30, 2020, to Jan 15, 2021. In her judgment, Rofiah said she considered the remorse and suffering endured by the woman during the five years she had been on bail, which she described as severe enough to cause trauma and mental distress to both the accused and her family, likening their experience to "living in hell.' She said the court also took into account the public interest and her guilty plea as well as her mental health, where a psychiatric evaluation by Hospital Bahagia Ulu Kinta, Perak, confirmed she suffered from severe depression (Major Depressive Disorder) and continues to require treatment and medication. "Based on these circumstances, the court has opted for a sentence that is more restorative than punitive. On the day of the incident, the accused had actually intended to take her own life after giving birth,' said the judge. At the time of the offence, the accused was 18 years old and initially charged under Section 302 of the Penal Code with murdering her baby by causing her death on a pathway leading to the parking area on the fourth floor of the Sri Ivory Apartment, Bandar Baru Ayer Itam, at about 8.25 am on July 10, 2020. The offence carries the death penalty upon conviction. She was charged while receiving treatment in the maternity ward of Penang Hospital for severe blood loss and complications following childbirth. However, the prosecution later offered an alternative charge after considering her mental state and witness testimonies. Under Section 309A of the Penal Code, a woman who causes the death of her newborn while suffering from mental disturbances due to not fully recovering from childbirth may be convicted of infanticide, which carries a maximum sentence of 20 years' imprisonment and a fine upon conviction. The prosecution was led by Deputy Public Prosecutor Nurul Khairiah Dahalaan, while the accused was represented by lawyer RSN Rayer. The proceedings were also attended by Southeast District Social Welfare Department Community Service Command Officer Mohd Zahir Harun. - BERNAMA More Like This
National Post
31-07-2025
- Business
- National Post
MindMed Reports Q2 2025 Financial Results and Business Updates
Article content –Strong enrollment continues in all three Phase 3 trials of MM120 Orally Disintegrating Tablet (ODT) in Generalized Anxiety Disorder (GAD) and Major Depressive Disorder (MDD)– Article content –Data from the Phase 3 Voyage trial in GAD anticipated in 1H 2026 and data from the Phase 3 Panorama trial in GAD and Phase 3 Emerge trial in MDD anticipated in 2H 2026– Article content Article content –Strengthened leadership team with appointment of Brandi L. Roberts as Chief Financial Officer– Article content –Conference call scheduled today at 4:30 p.m. EDT– Article content NEW YORK — Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the 'Company' or 'MindMed'), a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced its second quarter 2025 financial results and provided an update on business highlights. 'We continue making significant progress across all three of our pivotal Phase 3 trials evaluating MM120 ODT in GAD and MDD, with ongoing enthusiasm from both trial sites and participants driving strong enrollment,' said Rob Barrow, Chief Executive Officer of MindMed. 'We remain on track to report topline data from our Phase 3 Voyage trial in the first half of 2026, followed by Panorama and Emerge in the second half of the year. In parallel, we are advancing our commercial strategy and have continued to strengthen our leadership team with the appointment of Brandi Roberts as Chief Financial Officer. With our clearly defined regulatory strategy, disciplined operational execution, and strong balance sheet, we are well-positioned to advance MM120 ODT as a potential best-in-class therapeutic option for the treatment of GAD and MDD.' Article content Business Highlights Article content Progressing Pivotal Trials: Strong enrollment continues across all three MM120 ODT Phase 3 trials: Voyage and Panorama in GAD and Emerge in MDD. The continued execution reinforces the Company's targeted trial timelines and progress in preparing for a potential NDA filing. Strengthened Leadership for Growth: Appointed Brandi L. Roberts as Chief Financial Officer. Ms. Roberts brings more than 25 years of financial leadership experience within the life sciences industry. As a member of the executive team, she leads all aspects of the Company's financial strategy, capital planning, accounting, investor relations and information technology. Article content MM120 ODT (lysergide D-tartrate) for GAD Article content Enrollment is on track in the Phase 3 Voyage study of MM120 ODT for the treatment of GAD. Voyage is expected to enroll approximately 200 participants in the U.S. who will be randomized 1:1 to receive MM120 ODT 100 µg or placebo. Topline data from the 12-week double-blind period (Part A) is anticipated in the first half of 2026. Enrollment is on track in the Panorama study, the Company's second Phase 3 study of MM120 ODT for the treatment of GAD. Panorama is expected to enroll approximately 250 participants (randomized 2:1:2 to receive MM120 ODT 100 µg, MM120 ODT 50 µg or placebo) in the U.S. and Europe. Topline data from the 12-week double-blind period (Part A) is anticipated in the second half of 2026. Article content MM120 (lysergide D-tartrate) for MDD Article content Enrollment is on track in the Phase 3 Emerge study of M120 ODT for the treatment of MDD. Emerge is expected to enroll 140 participants (randomized 1:1 to receive MM120 ODT 100 µg or placebo). Topline data from the 12-week double-blinded period (Part A) is anticipated in the second half of 2026. The Company expects to conduct a second Phase 3 registrational study in MDD, with the study design and timing to be informed by the progress of Emerge and additional regulatory discussions. Article content MM402 (R(-)-MDMA) for Autism Spectrum Disorder (ASD) Article content Completed a Phase 1 study of MM402, a single-ascending dose study in adult healthy volunteers. The study characterized the tolerability, pharmacokinetics and pharmacodynamics of MM402. The Company expects to initiate further studies of MM402 to assess its potential efficacy for the treatment of ASD. Article content Cash Balance. Article content As of June 30, 2025, MindMed had cash, cash equivalents and investments totaling $237.9 million compared to $245.5 million as of March 31, 2025. Article content Based on the Company's current operating plan and anticipated R&D milestones, the Company believes that its cash, cash equivalents and investments as of June 30, 2025 will be sufficient to fund the Company's operations into 2027 and at least 12 months beyond its first Phase 3 topline data readout for MM120 ODT in GAD. Article content Research and Development (R&D). Article content R&D expenses were $29.8 million for the quarter ended June 30, 2025, compared to $14.6 million for the quarter ended June 30, 2024, an increase of $15.2 million. The net increase of $15.2 million was primarily related to increases of $14.5 million related to our MM120 ODT program, $1.5 million in internal personnel costs as a result of increased headcount, and $0.2 million related to preclinical activities, offset by a decrease of $1.0 million in MM402 program expenses based on the timing of studies. Article content General and Administrative (G&A). Article content G&A expenses were $11.1 million for the quarter ended June 30, 2025, compared to $9.8 million for the quarter ended June 30, 2024, an increase of $1.3 million. The increase was primarily related to increases in personnel costs as a result of increased headcount. Article content Net Loss. Article content Net loss for the quarter ended June 30, 2025, was $42.7 million, compared to $5.9 million for the same period in 2024, a decrease of $36.8 million. The decrease was primarily due to increases in operating expenses of $16.4 million, changes in the fair value of warrants issued in our September 2022 underwritten offering of $15.6 million, the absence of a $2.5 million gain on extinguishment of contribution payable from 2024 and increased interest expense related primarily to the amendment of our credit facility of $1.8 million. Article content Conference Call and Webcast Reminder Article content MindMed management will host a webcast at 4:30 p.m. EDT today to provide a corporate update and review the Company's second quarter 2025 financial results, and business highlights. Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the Investor Relations section of the MindMed website, and archived for at least 30 days after the webcast. Those who plan on participating are advised to join 15 minutes prior to the start time. Article content About MM120 Orally Disintegrating Tablet (ODT) Article content MM120 ODT (lysergide D-tartrate or LSD) is a synthetic ergotamine belonging to the group of classic, or serotonergic, psychedelics which acts as a partial agonist at human serotonin-2A (5-HT2A) receptors. MM120 ODT is MindMed's proprietary and pharmaceutically optimized form of LSD. MM120 ODT is an advanced formulation incorporating Catalent's Zydis® ODT fast-dissolve technology which has a unique clinical profile with more rapid absorption, improved bioavailability and reduced gastrointestinal side effects. MindMed is developing MM120, the tartrate salt form of lysergide, for generalized anxiety disorder (GAD), major depressive disorder (MDD), and is exploring its potential applications in other serious brain health disorders. Article content About MM402 Article content MM402 is the Company's proprietary form of R(-)-MDMA (rectus-3,4-methylenedioxymethamphetamine), being developed for the treatment of core symptoms of Autism Spectrum Disorder (ASD). MDMA is a synthetic molecule that is often referred to as an empathogen because it is reported to increase feelings of connectedness and compassion. Preclinical studies of R(-)-MDMA demonstrate its acute pro-social and empathogenic effects, while its diminished dopaminergic activity suggest that it has the potential to exhibit less stimulant activity, neurotoxicity, hyperthermia and abuse liability compared to racemic MDMA or the S(+)-enantiomer. Article content About MindMed Article content MindMed is a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health. MindMed trades on NASDAQ under the symbol MNMD. Article content Forward-Looking Statements Article content Certain statements in this news release related to the Company constitute 'forward-looking information' within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as 'will', 'may', 'should', 'could', 'intend', 'estimate', 'plan', 'anticipate', 'expect', 'believe', 'potential' or 'continue', or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, statements regarding the Company's anticipated topline readout (Part A results) for the Phase 3 Voyage study of MM120 ODT in GAD in the first half of 2026; the Company's anticipated topline readout (Part A results) for the Phase 3 Panorama study for MM120 ODT in GAD in the second half of 2026; the Company's anticipated topline readout (Part A results) for the Phase 3 Emerge study for MM120 ODT in MDD in the second half of 2026; the Company's plans to conduct a second Phase 3 study in MDD; the Company's expectations regarding the enrollment for each of the Voyage, Panorama and Emerge studies; the Company's beliefs regarding potential benefits of its product candidates; the Company's expectation to conduct further studies of MM402; the Company's expectation that its cash, cash equivalents and investments will fund operations into 2027; the Company's expectation that its cash runway will extend at least 12 months beyond its first Phase 3 topline data readout for MM120 ODT in GAD; and potential additional indications for MM120 ODT and MM402. There are numerous risks and uncertainties that could cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; compliance with laws and regulations; legislative and regulatory developments, including decisions by the Drug Enforcement Administration and states to reschedule any of our product candidates, if approved, containing Schedule I controlled substances, before they may be legally marketed in the U.S.; difficulty associated with research and development; risks associated with clinical studies or studies; heightened regulatory scrutiny; early stage product development; clinical study risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; ability to maintain effective patent rights and other intellectual property protection; as well as those risk factors discussed or referred to herein and the risks, uncertainties and other factors described in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and the Company's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2025 under headings such as 'Special Note Regarding Forward-Looking Statements,' and 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' and other filings and furnishings made by the Company with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company's profile on SEDAR+ at and with the U.S. Securities and Exchange Commission on EDGAR at Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise. Article content Mind Medicine (MindMed) Inc. Consolidated Statements of Operations and Comprehensive Loss (Unaudited) Three Months Ended June 30, Six Months Ended June 30, (in thousands, except share and per share amounts) 2025 2024 2025 2024 Operating expenses: Research and development $ 29,809 $ 14,645 $ 53,166 $ 26,350 General and administrative 11,094 9,813 19,896 20,312 Total operating expenses 40,903 24,458 73,062 46,662 Loss from operations (40,903 ) (24,458 ) (73,062 ) (46,662 ) Other income/(expense): Interest income 2,774 3,116 5,207 4,772 Interest expense (2,338 ) (466 ) (2,940 ) (900 ) Foreign exchange loss, net (49 ) (32 ) (68 ) (557 ) Change in fair value of 2022 USD Financing Warrants (2,228 ) 13,445 4,771 (19,448 ) Gain on extinguishment of contribution payable — 2,541 — 2,541 Total other income/(expense) (1,841 ) 18,604 6,970 (13,592 ) Net loss (42,744 ) (5,854 ) (66,092 ) (60,254 ) Other comprehensive loss Unrealized gain on investments 36 — 46 — Gain/(loss) on foreign currency translation (31 ) (3 ) (58 ) 490 Comprehensive loss $ (42,739 ) $ (5,857 ) $ (66,104 ) $ (59,764 ) Net loss per common share, basic $ (0.50 ) $ (0.08 ) $ (0.78 ) $ (1.01 ) Net loss per common share, diluted $ (0.50 ) $ (0.26 ) $ (0.81 ) $ (1.01 ) Article content Article content Article content Article content Article content Contacts Article content For Media: Article content Article content Article content
National Post
17-07-2025
- Business
- National Post
Cybin Receives UK MHRA Approval to Commence EMBRACE, A Multinational Pivotal Study Evaluating CYB003 for the Adjunctive Treatment of Major Depressive Disorder
Article content Article content the United States, Europe and Australia and will commence imminently – Article content – PARADIGM TM comprises two 12-week randomized, double-blind, placebo-controlled studies (APPROACH® and EMBRACE®) and a long-term extension study (EXTEND), with anticipated combined enrollment of approximately 550 participants – Article content – Dosing is currently underway in the first pivotal study, APPROACH, and patient rollover has begun into EXTEND – Article content TORONTO — Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (' Cybin ' or the ' Company '), a clinical-stage breakthrough neuropsychiatry company committed to advancing mental healthcare by developing new and innovative next-generation treatment options, today announced that it has received approval from the UK Medical and Healthcare Products Regulatory Agency ('MHRA') to commence EMBRACE, the second pivotal study in PARADIGM, the Company's Phase 3 multinational program evaluating CYB003, a proprietary deuterated psilocin analog. The Company previously received Breakthrough Therapy Designation from the U.S. Food and Drug Administration ('FDA') for CYB003 for the adjunctive treatment of Major Depressive Disorder ('MDD'). Article content 'MHRA approval to initiate the EMBRACE component of our PARADIGM program in the UK marks an important step forward as we advance our lead program, CYB003, through the regulatory process,' said Doug Drysdale, Chief Executive Officer of Cybin. 'The Agency's decision serves as strong validation of both the quality of our data and the urgent need to develop new and effective therapeutics to treat depression. With expected enrollment of 330 participants suffering from moderate to severe MDD, the EMBRACE study aims to generate critical late-stage data that, ultimately, may lead to transforming the standard of care for patients in need.' Article content 'There are encouraging signs of clinical and commercial success across this sector, along with increasing political and regulatory support. Health expert Dr. Martin Makary, Commissioner of the U.S Food and Drug Administration, has publicly recognized the potential value of these innovative therapeutics and has stated his intention to prioritize and expedite the review process. The commercial success of esketamine is also a positive signal for the entire sector. In the second quarter of 2025, esketamine sales totaled $366 million in the U.S. and $414 million worldwide, representing 61.1% growth year over year in the U.S., and an annual run rate of roughly $1.7 billion. 1 These positive factors contribute to the credibility and opportunity of the work we are doing at Cybin,' concluded Drysdale. Article content Study Design: Article content EMBRACE will enroll 330 patients suffering from moderate to severe MDD (MADRS≥24) who are on a stable dose of antidepressant medication but are responding inadequately. Study participants will be randomized 1:1:1 to receive either CYB003 16 mg, CYB003 8 mg, or inactive placebo. Each study arm will evaluate two doses, administered three weeks apart. The primary endpoint will be change in depressive symptoms as measured by change in MADRS from baseline at six weeks after the first dose. Article content EMBRACE is the second Phase 3 randomized, double-blind clinical trial in the PARADIGM program, and is expected to enroll participants at approximately 60 clinical sites across the U.S., Europe, and Australia. The first Phase 3 trial, APPROACH, is taking place at approximately 45 clinical sites across the U.S. Participants from APPROACH and EMBRACE will have the opportunity to roll over into EXTEND after completing the 12-week, double-blind, placebo-controlled treatment periods. Sources Article content Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions. Article content With promising proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The Company also has a research pipeline of investigational, 5-HT-receptor focused compounds. Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit or follow the team on X, LinkedIn, YouTube and Instagram. Article content Cautionary Notes and Forward-Looking Statements Article content Certain statements in this news release relating to the Company are forward-looking statements or forward-looking information within the meaning of applicable securities laws (collectively, 'forward-looking statements') and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as 'may', 'should', 'could', 'potential', 'possible', 'intend', 'estimate', 'plan', 'anticipate', 'expect', 'believe' or 'continue', or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company's plans to enroll participants and add additional clinical sites for the PARADIGM program; the timing of commencement of EMBRACE; the Company's plan to enroll 330 participants at 60 clinical sites across the United States, Europe and Australia for the EMBRACE study; and the Company's plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions. APPROACH and EMBRACE are registered trademarks of Cybin IRL Limited, a subsidiary of Cybin. Article content These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company's operations; and the risk factors set out in each of the Company's management's discussion and analysis for the year ended March 31, 2025 and the Company's annual information form for the year ended March 31, 2025, which are available under the Company's profile on SEDAR+ at and with the U.S. Securities and Exchange Commission on EDGAR at Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. Article content Cybin makes no medical, treatment or health benefit claims about Cybin's proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin's performance and operations. Article content Article content Article content Article content Contacts Article content Investor & Media Contact: Article content Article content Gabriel Fahel Article content Article content Chief Legal Officer Article content Article content Cybin Inc. Article content Article content Article content Article content
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
