An Open-label Phase 1 Trial to Determine the Pharmacokinetics, Pharmacodynamics, and Safety of GH001 Administered Via a Proprietary Aerosol Delivery Device in Healthy Subjects

The primary objectives of this trial are to determine the pharmacokinetic (PK) profile and the safety and tolerability of GH001 delivered via a proprietary aerosol delivery device in healthy subjects after single-dose administration and a single-day individualized dosing regimen (IDR). As secondary objectives, the mebufotenin PK/ pharmacodynamic (PD) relationship, the PD profile of GH001 as evaluated by its psychoactive effects (PsE), the impact on cognitive performance, and the TCmax/2 and TCmax/10 (time taken for Cmax to decrease by 50 and 90%, respectively) are also assessed.

Start Date01 Aug 2024

Sponsor / Collaborator

GH Research Plc

NCT05870540 / RecruitingPhase 2

A Quadruple Masked, Dose-Finding Study to Evaluate the Efficacy and Safety of Intranasal BPL-003 in Patients With Treatment Resistant Depression

This is a Phase 2 study randomized, quadruple masked, multi-center study designed to investigate the efficacy and safety of a single dose of BPL-003 combined with psychological support in patients with treatment resistant depression (TRD).

Start Date14 Sep 2023

Sponsor / Collaborator

Beckley Psytech Ltd.Startup

ACTRN12623000884606 / Not yet recruitingPhase 1IIT

Effects of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) administered by intramuscular injection on frequency oscillatory power bands in healthy adults

Start Date01 Sep 2023

Sponsor / Collaborator

Swinburne University of Technology

100 Clinical Results associated with 5-MeO-DMT

100 Translational Medicine associated with 5-MeO-DMT

100 Patents (Medical) associated with 5-MeO-DMT

687

Literatures (Medical) associated with 5-MeO-DMT

31 Dec 2024·Plant Signaling & Behavior

Views and perspectives on the indoleamines serotonin and melatonin in plants: past, present and future

Review

Author: Erland, Lauren A E

In the decades since their discovery in plants in the mid-to-late 1900s, melatonin (N-acetyl-5-methoxytryptamine) and serotonin (5-methoxytryptamine) have been established as their own class of phytohormone and have become popular targets for examination and study as stress ameliorating compounds. The indoleamines play roles across the plant life cycle from reproduction to morphogenesis and plant environmental perception. There is growing interest in harnessing the power of these plant neurotransmitters in applied and agricultural settings, particularly as we face increasingly volatile climates for food production; however, there is still a lot to learn about the mechanisms of indoleamine action in plants. A recent explosion of interest in these compounds has led to exponential growth in the field of melatonin research in particular. This concept paper aims to summarize the current status of indoleamine research and highlight some emerging trends.

01 Dec 2024·NEUROSCIENCE AND BIOBEHAVIORAL REVIEWS

Psychedelics: A review of their effects on recalled aversive memories and fear/anxiety expression in rodents

Review

Author: Bertoglio, Leandro J ; Werle, Isabel ; Bertoglio, Leandro J.

Threatening events and stressful experiences can lead to maladaptive memories and related behaviors. Existing treatments often fail to address these issues linked to anxiety/stress-related disorders effectively. This review identifies dose ranges associated with specific actions across various psychedelics. We examined psilocybin/psilocin, lysergic acid diethylamide (LSD), N,N-dimethyltryptamine (DMT), mescaline, 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), serotonin 2 A/2 C agonists (e.g., DOI) and 3,4-methylenedioxymethamphetamine (MDMA) on aversive memory extinction and reconsolidation, learned fear, anxiety, and locomotion in rodents. Nearly 400 studies published since 1957 were reviewed. Psychedelics often show biphasic effects on locomotion at doses that enhance extinction learning/retention, impair memory reconsolidation, or reduce learned fear and anxiety. Emerging evidence suggests a dissociation between their prospective benefits and locomotor effects. Under-explored aspects include sex differences, susceptibility to interference as memories age and generalize, repeated treatments, and immediate vs. delayed changes. Validating findings in traumatic-like memory and maladaptive fear/anxiety models is essential. Understanding how psychedelics modulate threat responses and post-retrieval memory processes in rodents may inform drug development and human studies, improving therapeutic approaches for related psychiatric conditions.

01 Sep 2024·Protoplasma

Involvement of ROS and calcium ions in developing heat resistance and inducing antioxidant system of wheat seedlings under melatonin’s effects

Article

Author: Karpets, Yuriy V ; Kolupaev, Yuriy E ; Taraban, Dmytro A ; Yastreb, Tetiana O ; Kokorev, Alexander I ; Blume, Yaroslav B ; Yemets, Alla I

The stress-protective effect of melatonin (N-acetyl-5-methoxytryptamine) on plant cells is mediated by key signaling mediators, in particular calcium ions and reactive oxygen species (ROS). However, the links between changes in calcium and redox homeostasis and the formation of adaptive responses of cultivated cereals (including wheat) to the action of high temperatures have not yet been studied. In the present study, we investigated the possible involvement of ROS and calcium ions as signaling mediators in developing heat resistance in wheat (Triticum aestivum L.) seedlings and activating their antioxidant system. Treatment of 3-day-old etiolated seedlings with melatonin solutions at concentrations 0.01-10 µM increased their survival after exposure to 45 °C for 10 min. The most significant stress-protective effect was exerted by melatonin treatment at 1 µM concentration. Under the influence of melatonin, a transient enhancement of superoxide anion radical (O₂^•-) generation and an increase in hydrogen peroxide content were observed in roots, with a maximum at 1 h. Four hours after treatment with melatonin, the activity of catalase and guaiacol peroxidase increased in roots, while the activity of superoxide dismutase did not change significantly. After exposure to 45 °C, the activity of catalase and guaiacol peroxidase was higher in the roots of melatonin-treated wheat seedlings, and the indices of ROS generation, content of the lipid peroxidation product malonic dialdehyde, and cell membrane damage were lower than in control seedlings. Melatonin-induced changes in root ROS generation and antioxidant enzyme activities were eliminated by pretreatment with the hydrogen peroxide scavenger dimethylthiourea (DMTU), NADPH oxidase inhibitor imidazole, and calcium antagonists (the extracellular calcium chelator EGTA and phospholipase C inhibitor neomycin). Treatment with DMTU, imidazole, EGTA, and neomycin also abolished the melatonin-induced increase in survival of wheat seedlings after heat stress. The role of calcium ions and ROS, generated with the participation of NADPH oxidase, as signaling mediators in the melatonin-induced antioxidant system and heat stress resistance of wheat seedlings have been demonstrated.

News (Medical) associated with 5-MeO-DMT

03 Sep 2024

·www.globenewswire.com

GH Research Reports Second Quarter 2024 Financial Results and Provides Business Updates

Phase 2b clinical trial of GH001 in patients with treatment-resistant depression on track for expected completion of double-blind phase in Q3 2024 and expected completion of 6-month open-label extension phase in Q1 2025Phase 1 clinical trial to evaluate proprietary aerosol delivery device in healthy adult subjects approved in the UK and recruitingCash, cash equivalents, other financial assets and marketable securities of $204.5 million DUBLIN, Sept. 03, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the second quarter ended June 30, 2024, and provided updates on its business. Business Updates We announced today, in a separate press release, the promotion of Dr. Velichka “Villy“ Valcheva, MD, MSc. to Chief Executive Officer of the Company. Dr. Valcheva succeeds PD Dr. med. Theis Terwey, co-founder of GH Research. GH001 in Patients with TRD GH001, our proprietary inhaled mebufotenin (5-MeO-DMT) product candidate, is currently being investigated in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial in approximately 80 patients with treatment-resistant depression (TRD) (GH001-TRD-201) with approximately 20 sites across seven European countries. We continue to recruit according to plan, supporting the expected completion of the double-blind phase of this trial in the third quarter of 2024 and of the 6-month open-label extension in the first quarter of 2025. Top-line data for the double-blind phase is expected to be available in the fourth quarter of 2024 or the first quarter of 2025. In this trial, GH001 is administered using a commercially available inhalation device. Consistent with previously completed trials, GH001 is administered on a single initial dosing day, without additional mandated visits for psychotherapy or psychological support before or after dosing. GH001 in Patients with PPD and BDII GH001 is being investigated in a proof-of-concept clinical trial in patients with postpartum depression (PPD) (GH001-PPD-203). We expect GH001-PPD-203 completion in the fourth quarter of 2024. GH001 is also being investigated in a proof-of-concept clinical trial in bipolar II disorder in patients with a current depressive episode (BDII) (GH001-BD-202). GH001 Administered with Proprietary Aerosol Delivery Device We previously announced our submission of a clinical trial application for a Phase 1 clinical pharmacology trial in Europe to evaluate our proprietary aerosol delivery device for administration of GH001 in healthy volunteers (GH001-HV-106). This trial is designed to support bridging to the clinical data generated with the commercial device we have used, and are using, in our clinical trials to date. This trial has recently received full regulatory and ethical approval in the United Kingdom and is now recruiting. Update on IND for GH001 As previously announced, our Investigational New Drug Application (IND) for GH001 administered using our proprietary aerosol delivery device was placed on clinical hold by the U.S. Food and Drug Administration (FDA), with the FDA requesting that we provide additional information, including (i) an inhalation toxicology study in a non-rodent species and an additional inhalation toxicology study in rats, (ii) additional device design verification information and (iii) updates to our investigator brochure, to resolve the hold. We requested a meeting with the FDA to discuss specific aspects of their device feedback and this meeting was executed by way of written response. We believe we now have a path to finalize the device element of our IND hold complete response. The nonclinical studies to address the inhalation toxicology aspect of the hold are ongoing: these results are required for the submission of our complete response to the FDA. GH002 GH002 is our proprietary intravenous mebufotenin (5-MeO-DMT) product candidate. With GH002, we have recently completed a Phase 1, dose-ranging clinical pharmacology trial in healthy volunteers (GH002-HV-105). This trial demonstrated that GH002 was well-tolerated and produced potent pharmacodynamic (PD) effects, as assessed by psychoactive effect intensity, with an ultra-rapid onset and short duration psychoactive experience. The pharmacokinetic (PK) profile of GH002 correlated with the ultra-rapid profile of the psychoactive effects. Second Quarter 2024 Financial Highlights Cash position Cash, cash equivalents, other financial assets and marketable securities were $204.5 million as of June 30, 2024, compared to cash, cash equivalents, other financial assets and marketable securities of $222.7 million as of December 31, 2023. Other financial assets are comprised of money market funds, and marketable securities are comprised of investment grade bonds. We believe that our existing cash, cash equivalents, other financial assets and marketable securities will be sufficient for us to fund our operating expenses and capital expenditure requirements into 2026. Research and development expenses R&D expenses were $9.8 million for the quarter ended June 30, 2024, compared to $7.2 million for same quarter in 2023. The increase is primarily due to increased expenses relating to our clinical development activities including clinical trials and nonclinical activities, partly offset by a decrease in technical development expenses. General and administrative expenses G&A expenses were $3.5 million for the quarter ended June 30, 2024, compared to $2.7 million for the same quarter in 2023. The increase is primarily due to an increase in professional fees and employee expenses in our general and administrative functions to support our growth initiatives. Net loss Net loss was $10.4 million, or $0.20 loss per share, for the quarter ended June 30, 2024, compared to $7.7 million, or $0.15 loss per share, for the same quarter in 2023. About GH Research PLC GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders. GH Research PLC's initial focus is on developing its novel and proprietary mebufotenin (5-MeO-DMT) therapies for the treatment of patients with treatment-resistant depression (TRD). GH Research PLC's annual report on Form 20-F filed with the U.S. Securities and Exchange Commission for the year ended December 31, 2023 is available at www.ghres.com and shareholders may receive a hard copy free of charge upon request. About GH001 Our lead product candidate, GH001, is formulated for mebufotenin (5-MeO-DMT) administration via a proprietary inhalation approach. With GH001, we have completed two Phase 1 healthy volunteer clinical trials and a Phase 1/2 clinical trial in patients with TRD. Based on the observed clinical activity, where 87.5% of patients with TRD achieved ultra-rapid remission with our GH001 individualized single-day dosing regimen in the Phase 2 part of the trial, we believe that GH001 has the potential to change the way TRD is treated today. About GH002 and GH003 GH002 is our mebufotenin (5-MeO-DMT) product candidate formulated for administration via a proprietary intravenous approach. We have completed a Phase 1 trial of GH002 in healthy volunteers. GH003 is our mebufotenin (5-MeO-DMT) product candidate formulated for administration via a proprietary intranasal administration approach. GH003 is currently in preclinical development. We anticipate developing GH002 and GH003 within our focus areas of psychiatric and neurological disorders. Forward-Looking Statements This press release contains statements that are, or may be deemed to be, forward-looking statements. All statements other than statements of historical fact included in this press release, including statements regarding our future results of operations and financial position, business strategy, product candidates, medical devices required to deliver these product candidates, research pipeline, ongoing and currently planned preclinical studies and clinical trials, regulatory submissions and approvals and their effects on our business strategy, including our plans and expectations related to addressing the clinical hold on the GH001 IND, research and development costs, cash runway, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this press release speak only as of the date hereof. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Investor Relations:Julie RyanGH Research PLCinvestors@ghres.com GH RESEARCH PLCCondensed Consolidated Interim Statement of Comprehensive Income (Unaudited)(in thousands, except share and per share amounts) Three months endedJune 30, Six months endedJune 30, 20242023 20242023 $’000$’000 $’000$’000 Operating expenses Research and development(9,755)(7,176) (18,413)(14,482)General and administration(3,464)(2,749) (6,334)(5,862)Loss from operations(13,219)(9,925) (24,747)(20,344) Finance income2,5552,122 5,2253,611Finance expense(178)(179) (357)(350)Movement of expected credit loss(3)217 4718Foreign exchange gain/(loss)46636 1,787(1,601)Total other income2,8402,196 6,7021,678 Loss before tax(10,379)(7,729) (18,045)(18,666)Tax charge/(credit)-- --Loss for the period(10,379)(7,729) (18,045)(18,666) Other comprehensive (expense)/income Items that may be reclassified to profit or loss Fair value movement on marketable securities(107)(1,512) (650)(788)Currency translation adjustment(446)(57) (1,735)1,619Total comprehensive loss for the period(10,932)(9,298) (20,430)(17,835) Attributable to owners: Loss for the period(10,379)(7,729) (18,045)(18,666)Total comprehensive loss for the period(10,932)(9,298) (20,430)(17,835) Loss per share Basic and diluted loss per share (in USD)(0.20)(0.15) (0.35)(0.36) GH RESEARCH PLCCondensed Consolidated Interim Balance Sheet (Unaudited)(in thousands) At June 30,At December 31, 20242023 $’000$’000ASSETS Current assets Cash and cash equivalents 87,13178,420Other financial assets 41,96555,615Marketable securities 22,21927,525Other current assets 1,5962,529Total current assets 152,911164,089Non-current assets Marketable securities 53,16961,142Property, plant and equipment 8961,069Total non-current assets 54,06562,211Total assets 206,976226,300 LIABILITIES AND EQUITY Current liabilities Trade payables 2,5723,490Lease liability 263343Other current liabilities 4,9672,868Total current liabilities 7,8026,701Non-current liabilities Lease liability 497631Total non-current liabilities 497631Total liabilities 8,2997,332 Equity attributable to owners Share capital 1,3011,301Additional paid-in capital 291,463291,463Other reserves 3,7134,651Foreign currency translation reserve (12,242)(10,507)Accumulated deficit (85,558)(67,940)Total equity 198,677218,968Total liabilities and equity 206,976226,300

Phase 2Phase 1Financial StatementExecutive ChangeClinical Result

03 Sep 2024

·www.globenewswire.com

GH Research Announces Appointment of Dr. Velichka “Villy” Valcheva to Chief Executive Officer

DUBLIN, Ireland, Sept. 03, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today announced the promotion of Dr. Velichka “Villy” Valcheva, MD, MSc. to Chief Executive Officer of the Company. Dr. Valcheva succeeds PD Dr. med. Theis Terwey, co-founder of GH Research. Dr. Valcheva has more than 20 years of experience in various leadership roles in the pharmaceutical and biotech industries. Dr. Valcheva joined the company in August 2023 and has served as the Company’s Chief Medical Officer since February 2024 having leadership responsibility, among other things, for the execution of the Company’s clinical development programs. She joined us from Albireo, where, in her position as VP and Head of Medical Affairs International, she played a pivotal role in the company’s late-stage development, scientific communication, regulatory approvals by the U.S. Food and Drug Administration and EMA as well as gaining market access in multiple markets of the rare disease medicine Bylvay. Dr. Valcheva holds a Masters in Pharmaceutical Medicine from Trinity College Dublin, Ireland as well as a Dr. Med. from University of Medicine – Plovdiv, Bulgaria. Florian Schönharting, Chairman of the Board of Directors, GH Research, said: “We are very pleased to promote Dr. Valcheva to Chief Executive Officer. As Chief Medical Officer, she has proven her operating and execution skills, and she has the experience base and track record to lead GH Research through its next stage of development to achieve our goal of providing effective therapies for patients suffering from depression. I would also like to thank Theis for his dedication, passionate commitment and scientific rigor applied to our mission since we founded the Company together.” Dr. Valcheva, Chief Executive Officer, GH Research, added: “Since joining GH Research last year, I have worked tirelessly to realize the potential of our product candidates to help patients with depression. As we’re screening the remaining patients for our phase 2b trial in treatment-resistant depression, we’re on track for completion of enrolment in September this year. Additionally, our phase 1 healthy volunteer study using our proprietary device is now actively enrolling in the UK. I’m excited to lead the company through the next phase of development. The foundation that Theis has laid will always be a part of GH Research.” “Taking part in the founding of GH Research and leading it in its mission has been a great honor for me and I look forward to seeing the company continue to advance its cause,” said departing CEO, Dr. Terwey. About GH Research PLC GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders. GH Research PLC's initial focus is on developing its novel and proprietary mebufotenin (5-MeO-DMT) therapies for the treatment of patients with treatment-resistant depression (TRD). GH Research PLC's annual report on Form 20-F filed with the U.S. Securities and Exchange Commission for the year ended December 31, 2023 is available at www.ghres.com and shareholders may receive a hard copy free of charge upon request. Forward-Looking Statements This press release contains statements that are, or may be deemed to be, forward-looking statements. All statements other than statements of historical fact included in this press release, including statements regarding our future results of operations and financial position, business strategy, product candidates, medical devices required to deliver these product candidates, research pipeline, ongoing and currently planned preclinical studies and clinical trials, regulatory submissions and approvals and their effects on our business strategy, including our plans and expectations related to addressing the clinical hold on the GH001 IND, research and development costs, cash runway, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this press release speak only as of the date hereof. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Investor Relations:Julie RyanGH Research PLCinvestors@ghres.com

Phase 2Executive ChangePhase 1

16 Jul 2024

·www.outsourcing-pharma.com

Psychedelic drug investments surge in 2024: Key startups raising funds and closing deals

Investment in psychedelic drugs started booming in 2020. The lockdowns brought by the Covid-19 pandemic highlighted the importance of mental health, and the legalization of psychoactive compounds is progressively spreading worldwide. A key milestone was the FDA decision in 2020 to fast-track and award breakthrough designation to a depression treatment based on psilocybin from Compass Pathways, which is currently the largest public company specializing in psychedelic drug development. Since then, funds have been pouring into the field, and multiple VCs specializing in psychedelic medicine have been launched, such as PsyMed Ventures, Satori Neuro and Negev Capital. Simultaneously, many psychedelics developers have successfully listed on public markets, with major names including Compass Pathways, GH Research, Atai Life Sciences, Cybin and MindMed. While investment in psychedelic therapeutics slowed down last year, it picked up again in 2024 as psychedelic drugs progress through clinical trials and receive approval. These are the top startups that have been actively raising funds and closing deals in 2024 so far. Reunion Neuroscience Headquarters: Morristown, New Jersey, US Founded: 2022 Reunion Neuroscience is a spin-off company of Field Trip Health, a startup that ran a chain of clinics offering ketamine assisted therapy to treat depression, anxiety and PTSD across Canada and the US. In 2022, the company split its drug discovery and clinic management activities into two new entities; Reunion was created as the successor of the drug discovery division, which worked on the development of next-generation psychedelics. googletag.cmd.push(function () { googletag.display('text-ad1'); }); The company is developing psychedelic drugs that are structurally similar to classical psychedelics but have a shorter duration. These drugs target the serotonin 2A receptor (5HT2AR), which is a known target responsible for the antidepressant effects of psychedelics. In May 2024, Reunion Neuroscience raised $103 million in a series A fundraising led by MPM BioImpact and Novo Holdings. The funds are being used to support an ongoing phase 2 trial with Reunion’s lead candidate, RE104, in patients with postpartum depression. RE104 is a compound similar to psilocybin. In a phase 1 clinical trial, it was shown to be safe and well-tolerated, and to have a duration of three to four hours, shorter than the six to eight hours typical of psilocybin. In addition to the clinical program in postpartum depression, Reunion is planning to explore the potential of RE104 as a treatment for adjustment disorder in patients diagnosed with cancer. Lykos Therapeutics Headquarters: San Jose, California, US Founded: 2014 Lykos Therapeutics is a spin out of the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit organization that supports psychedelic science. The company was founded with the goal of bringing MDMA-assisted therapy through to FDA approval and commercialization. Midomafetamine (MDMA) is an entactogen, a class of psychoactive compounds that have known effects of increasing self-awareness and introspection. MDMA-assisted therapy consists of a combination of MDMA capsules and psychological intervention, including talk therapy. In January 2024, Lykos closed a $100 million series A financing round led by Helena. Along with the fundraising, the company announced the change of its name from MAPS PBC to Lykos Therapeutics. The new name references the Greek word for wolf to represent the company’s qualities. Lykos Therapeutics has filed an application with the FDA for the approval of MDMA-assisted therapy as a treatment for PTSD, based on data from two phase 3 trials. If approved, it would be the first psychedelic-assisted therapy approved for this condition. A decision from the FDA is expected as early as August, which would allow Lykos to launch the treatment in late 2024. In the meantime, the company has been using the funds from the series A fundraising to build a commercialization wing. Beckley Psytech Headquarters: Oxford, UK Founded: 2019 Beckley Psytech was founded by Amanda Feilding and her son Cosmo Feilding Mellen, who is the company’s CEO. Feilding has dedicated over 50 years to the scientific exploration of the therapeutic potential of psychedelics, and is responsible for setting up the Beckley Foundation in 1998 as a non-profit organization focused on psychedelic research. Beckley Psytech was created to build upon the work of the Beckley Foundation by developing psychedelic medicines that could be integrated into mainstream medical practice to treat psychiatric and neurological conditions. In January 2024, Beckley Psytech announced a $50 million strategic investment from atai Life Sciences, one of the largest players in the field of psychedelics development. The purpose of the investment was to accelerate the development of Beckley Psytech’s two clinical stage candidates. The company’s lead candidate, BPL-003, is an intranasal formulation of 5-MeO-DMT, a psychedelic compound that is known for eliciting strong effects within a short time frame of about 20 minutes on average. BPL-003 is currently in phase 2 trials for treatment resistant depression and alcohol use disorder. Results from a previous phase 2a study have shown that a single dose of the drug candidate was able to induce an antidepressant response in 55% of patients. Gilgamesh Pharmaceuticals Headquarters: New York, US Founded: 2019 Gilgamesh Pharmaceuticals is a startup developing innovative treatment options for people suffering from mental illness. The company’s drug discovery efforts focus on new chemical entities that capture the therapeutic benefits of psychedelics with improved safety, tolerability, duration and efficacy. In May 2024, Gilgamesh signed a collaboration agreement with AbbVie consisting of a $65 million upfront payment and up to $1.95 billion in option fees and milestones. In exchange, AbbVie obtained the option to license, develop and commercialize novel neuroplastogens. These are next-generation psychedelic compounds that minimize the challenging effects of classic psychedelics, such as hallucinations, while retaining their clinical benefits. Gilgamesh’s drug discovery platform uses machine learning technology to accelerate and optimize the development of novel drugs using data from complex behavioral assessments, advanced electrophysiology and molecular measures of neuroplasticity. The company’s two lead clinical programs, GM-1020 and GM-2505, are currently being tested in phase 2 trials as treatments for patients with major depressive disorder. The company received a $14 million grant from the National Institute on Drug Abuse (NIDA) in March 2024. The funds will go towards the development of GM-3009, an analog of the psychedelic drug ibogaine, for the treatment of substance use disorders. With this candidate, Gilgamesh aims to mitigate the cardiovascular risks associated with ibogaine while potentially increasing its efficacy. Seaport Therapeutics Headquarters: Boston, Massachusetts, US Founded: 2024 Seaport Therapeutics is a spin-off of PureTech Health, a Boston-based biotechnology company with a history of highly successful spinouts such as Karuna Therapeutics, which was acquired by Bristol Myers Squibb for $14 billion earlier this year. Seaport was launched in April 2024 with a $100 million series A round from investors including ARCH Venture Partners, Sofinnova Investments and Third Rock Ventures. PureTech and Karuna founder Daphne Zohar stepped down as CEO of PureTech to lead Seaport Therapeutics when the launch was announced. Seaport’s Glyph technology platform leverages the lymphatic system to create new medicines for depression, anxiety and other neuropsychiatric disorders based on clinically validated mechanisms of action. The platform is designed to enable and enhance oral bioavailability, reduce hepatotoxicity and other side effects in drugs that were previously held back by those limitations. The company’s lead candidate, SPT-300, is currently in phase 2 clinical trials. The candidate is an oral prodrug of allopregnanolone, a compound that has demonstrated therapeutic benefit in a range of neuropsychiatric conditions but is currently only approved as an intravenous infusion. Seaport is also developing SPT-348, a prodrug of a non-hallucinogenic neuroplastogen that is intended to treat mood disorders and other neuropsychiatric conditions. For this program, the company leveraged its platform to create a potential first-in-class treatment with improved pharmacokinetics and tolerability compared to conventional psychedelics.

Phase 2Phase 1Phase 3

100 Deals associated with 5-MeO-DMT

External Link

KEGG	Wiki	ATC	Drug Bank
-	5-MeO-DMT	-	DB14010

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Alcohol Use Disorder	Phase 2	GB	Beckley Psytech Ltd.Startup	30 May 2023
Bipolar II disorder	Phase 2	DE	GH Research Plc	06 Apr 2023
Bipolar II disorder	Phase 2	NL	GH Research Plc	06 Apr 2023
Depressive Disorder, Major	Phase 2	DE	GH Research Plc	06 Apr 2023
Depressive Disorder, Major	Phase 2	NL	GH Research Plc	06 Apr 2023
Depression, Postpartum	Phase 2	NL	GH Research Plc	02 Mar 2023
Depression, Postpartum	Phase 2	GB	GH Research Plc	02 Mar 2023
Depressive Disorder, Treatment-Resistant	Phase 2	GB	Beckley Psytech Ltd.Startup	10 Feb 2023
Alzheimer Disease	Phase 2	AR	Biomind Labs, Inc.	-
Chronic Pain	Preclinical	CA	Biomind Labs, Inc.	08 Feb 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05660642 (Corporate Publications) Manual	Phase 2	Depressive Disorder, Treatment-Resistant	11	BPL-003 10mg	hbcypyiply(wygxtvpbzg) = pvkyhtbtlp gdsdewzopq (kvovrqsshq ) View more	Positive	27 Mar 2024
BusinessWire Manual	Phase 2	Alzheimer Disease \| Depressive Disorder \| Anxiety Disorders	40	BMND08 12mg	kftlikuopp(mmmqddscxv) = gwayflhoao bvwdxyrvkd (fhhhcnazpt ) View more	Positive	29 Feb 2024
BusinessWire Manual	Phase 2	Alzheimer Disease \| Depressive Disorder \| Anxiety Disorders	40	BMND08 9mg	kftlikuopp(mmmqddscxv) = sflwovpfuo bvwdxyrvkd (fhhhcnazpt )	Positive	29 Feb 2024

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis