5-Methoxy-N,N-diisopropyltryptamine

Beckley Psytech Launches Phase IIa Study of Lead Candidate BPL-003, a Novel Benzoate Formulation of 5-MeO-DMT, for Treatment Resistant Depression

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Wednesday, December 21, 2022
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, TRD, Beckley Foundation, MDD, 5-Methoxy-N,N-diisopropyltryptamine, Research, Depression (mood), Psychiatrist, Depression, University College London Hospitals NHS Foundation Trust, Patient, Treatment, Psilocybin, Safety, HMR, King's College London, King, Principal, Pharmaceutical industry

Beckley Psytech Ltd, a private, clinical-stage biotechnology company dedicated to addressing neuropsychiatric conditions through the novel application of psychedelic medicines, today announced that it had initiated a Phase IIa study investigating BPL-003, a proprietary intranasal formulation of synthetic 5-Methoxy-N, N-Dimethyltryptamine (5-MeO-DMT), for Treatment Resistant Depression (TRD).

Key Points: 
  • Beckley Psytech Ltd, a private, clinical-stage biotechnology company dedicated to addressing neuropsychiatric conditions through the novel application of psychedelic medicines, today announced that it had initiated a Phase IIa study investigating BPL-003, a proprietary intranasal formulation of synthetic 5-Methoxy-N, N-Dimethyltryptamine (5-MeO-DMT), for Treatment Resistant Depression (TRD).
  • Depression affects around 280 million people around the world , but 30% of those living with the condition are resistant to available antidepressant medications , meaning there is an urgent need for more effective treatments.
  • Patients will be followed for 12 weeks after initial dosing, with safety, pharmacokinetic and efficacy assessments conducted at multiple points throughout that period.
  • Cosmo Feilding Mellen, CEO of Beckley Psytech, said: “Conditions like Treatment Resistant Depression have a devastating effect on people around the world, but they are sadly underserved when it comes to treatment opportunities.

Beckley Psytech Successfully Completes Phase I Clinical Study of Lead Candidate BPL-003, a Novel Benzoate Formulation Of 5-MeO-DMT

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Tuesday, November 15, 2022
Research, Mental Health, Clinical Trials, Biotechnology, Alternative Medicine, Managed Care, Pharmaceutical, Health, Science, Other Science, 5-Methoxy-N,N-diisopropyltryptamine, MDD, TRD, Depression, N,N-Dimethyltryptamine, MHRA, Pharmacokinetics, Safety, Physician, CSO, Depression (mood), Psilocybin, Beckley Foundation, Patient, Treatment, Pharmaceutical industry

The double-blind, randomised, single ascending dose study ( NCT05347849 ) explored the safety, tolerability and pharmacokinetics of BPL-003 in combination with psychological support in 44 psychedelic-nave participants.

Key Points: 
  • The double-blind, randomised, single ascending dose study ( NCT05347849 ) explored the safety, tolerability and pharmacokinetics of BPL-003 in combination with psychological support in 44 psychedelic-nave participants.
  • Initial results show a dose-proportional pharmacokinetic (PK) profile and good tolerability with no serious adverse events reported.
  • With the robust data generated thus far from this Phase I study, Beckley Psytech is now preparing to initiate its MHRA-approved Phase IIa studies evaluating BPL-003 in Treatment Resistant Depression and Alcohol Use Disorder in Q4 2022.
  • Cosmo Feilding Mellen, CEO of Beckley Psytech, added: Beckley Psytech is making great progress in bringing this innovative formulation of 5-MeO-DMT to patients living with underserved conditions like Treatment Resistant Depression.

GH Research Reports Third Quarter 2022 Financial Results and Provides Business Updates

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Thursday, November 10, 2022
GLOBE, BDII, Forward-looking statement, IND, Form 20-F, Nasdaq, Food, TRD, PPD, IDR, Annual report, Research, MADRS, Postpartum depression, Bipolar II disorder, G&A, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, 5-Methoxy-N,N-diisopropyltryptamine, Psychiatry, U.S. Securities and Exchange Commission, Grammatical mood, Clinical trial, Patient, GHRS, Insurance, FDA, Pharmaceutical industry

DUBLIN, Ireland, Nov. 10, 2022 (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 third quarter ended September 30, 2022 and gave updates on its business.

Key Points: 
  • DUBLIN, Ireland, Nov. 10, 2022 (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 third quarter ended September 30, 2022 and gave updates on its business.
  • Cash was $256.9 million as of September 30, 2022, compared to $276.8 million as of December 31, 2021.
  • R&D expenses were $4.6 million for the quarter ended September 30, 2022, compared to $2.6 million for the same quarter in 2021.
  • G&A expenses were $2.0 million for the quarter ended September 30, 2022, compared to $2.1 million for the same quarter in 2021.

Lusaris Therapeutics Launches with $60 Million Series A Financing to Redefine the Treatment of Severe Neuropsychiatric and Neurological Disorders

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Wednesday, November 2, 2022
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, CMC, Migraine, Cluster headache, Liver, Water, Catalent, TRD, Board, Partner, Director, Physician, Zydis, 5-MeO-DMT, Interim, Regulatory affairs, RA, Technology, Metabolism, Therapy, Master of Philosophy, Patient, 5-Methoxy-N,N-diisopropyltryptamine, Tongue, Depression, CPA, Enzyme, Pharmaceutical industry, Discovery

Lusaris Therapeutics, a biotechnology company advancing next-generation serotonergic neuroplastogen therapeutics to treat severe neuropsychiatric and neurological conditions, launched today with a $60 million Series A financing.

Key Points: 
  • Lusaris Therapeutics, a biotechnology company advancing next-generation serotonergic neuroplastogen therapeutics to treat severe neuropsychiatric and neurological conditions, launched today with a $60 million Series A financing.
  • Psychoplastogens have emerged as a promising treatment approach supported by compelling scientific evidence in patients with TRD and other severe neuropsychiatric conditions.
  • Lusaris plans to develop LSR-1019 for the treatment of TRD and additional severe neuropsychiatric disorders.
  • Lusaris is a biotechnology company advancing next-generation serotonergic neuroplastogen therapeutics to treat severe neuropsychiatric and neurological disorders.

GH Research Reports Second Quarter 2022 Financial Results and Provides Business Updates

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Tuesday, August 23, 2022
Research, Psychiatry, IND, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Insurance, Lists of diseases, Postpartum depression, Food, Grammatical mood, U.S. Securities and Exchange Commission, Bipolar II disorder, GLOBE, IDR, 5-Methoxy-N,N-diisopropyltryptamine, Nasdaq, FDA, TRD, GHRS, G&A, Clinical trial, Annual report, Form 20-F, BDII, Forward-looking statement, PPD, Patient, MADRS, Pharmaceutical industry

DUBLIN, Ireland, Aug. 23, 2022 (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, 2022 and gave updates on its business.

Key Points: 
  • DUBLIN, Ireland, Aug. 23, 2022 (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, 2022 and gave updates on its business.
  • Cash was $265.4 million as of June 30, 2022, compared to $276.8 million as of December 31, 2021.
  • R&D expenses were $4.2 million for the quarter ended June 30, 2022, compared to $2.0 million for the same quarter in 2021.
  • G&A expenses were $2.5 million for the quarter ended June 30, 2022, compared to $0.7 million for the same quarter in 2021.

Beckley Psytech Announces Partnership With Ksana Health, Building on Digital Strategy to Deliver Optimised Patient Outcomes

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Tuesday, June 14, 2022
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Use, Biomarker, Lists of diseases, Mindfulness, Psychotherapy, Research, Sonoran, Anxiety, Mental health, Depression, Phase II, TRD, Depression (mood), CEO, University of Oregon, Partnership, Treatment, Center, EARS, University, 5-Methoxy-N,N-diisopropyltryptamine, Brain, Beckley Foundation, Patient, Technology, Clinical trial, Serotonin, Collection, Psilocybin, Patient safety, Health, Pharmaceutical industry, Medical imaging

This latest partnership further strengthens Beckley Psytechs digital strategy to develop personalised, end-to-end treatment programmes for patients in areas of significant unmet medical need.

Key Points: 
  • This latest partnership further strengthens Beckley Psytechs digital strategy to develop personalised, end-to-end treatment programmes for patients in areas of significant unmet medical need.
  • Cosmo Feilding Mellen, CEO of Beckley Psytech, said: This partnership with Ksana Health further supports our strategy to develop an integrated psychedelic treatment model, ensuring that patients are continuously supported throughout their treatment journey.
  • We look forward to working with Ksana Health and exploring how their state-of-the-art digital technology can help support patient safety and response in our upcoming Phase 2 clinical trials.
  • We are therefore very excited to partner with Beckley Psytech to help them build out their digital strategy.

Beckley Psytech Announces Partnership With Empatica in Latest Step of Digital Strategy, Designed to Deliver Personalised Patient Care

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Thursday, May 19, 2022
Science, Biotechnology, Research, Pharmaceutical, Alternative Medicine, Health, Mental Health, Clinical Trials, Addiction, Use, Software, Migraine, Serotonin, AI, Beckley Foundation, Multimedia, Patient, Psilocybin, Treatment, Sonoran, Mindfulness, Research, Psychotherapy, Brain, TRD, Sleep, Partnership, 5-Methoxy-N,N-diisopropyltryptamine, Anxiety, Safety, Technology, Biomarker, Depression (mood), Mental health, Collection, CEO, Pharmaceutical industry, Medical imaging, Empatica, Epilepsy, Depression

View the full release here: https://www.businesswire.com/news/home/20220518006041/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20220518006041/en/
    EmbracePlus is a medical-grade wearable that enables the passive, remote monitoring of physiological and behavioural signals.
  • The strategic partnership with Empatica is the latest step in Beckley Psytechs digital strategy to develop personalised treatment programmes for patients in need.
  • Beckley Psytech aims to establish a complete, end-to-end personalised psychedelic treatment programme, combining advanced digital phenotyping capabilities, such as those developed by Empatica, with psychedelic-assisted psychotherapy.
  • 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) is a psychoactive compound which binds to a variety of receptors within the brain pertaining to serotonin.

GH Research Reports First Quarter 2022 Financial Results and Provides Business Updates

Retrieved on: 
Wednesday, May 18, 2022
Chemistry, MADRS, G&A, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Research, Food, Nasdaq, Patient, Psychiatry, Clinical trial, Society, FDA, IND, TRD, 5-Methoxy-N,N-diisopropyltryptamine, GHRS, Lists of diseases, GLOBE, Pharmaceutical industry

DUBLIN, Ireland, May 18, 2022 (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 first quarter ended March 31, 2022 and gave updates on its business.

Key Points: 
  • DUBLIN, Ireland, May 18, 2022 (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 first quarter ended March 31, 2022 and gave updates on its business.
  • R&D expenses were $4.7 million for the quarter ended March 31, 2022, compared to $692 thousand for the same quarter in 2021.
  • G&A expenses were $3.3 million for the quarter ended March 31, 2022, compared to $448 thousand for the same quarter in 2021.
  • Net loss was $5.8 million, or $0.111 loss per share, for the quarter ended March 31, 2022, compared to $1.1 million, or $0.038 loss per share, for the same quarter in 2021.

Beckley Psytech Announces Dosing of First Healthy Volunteers in Phase 1 Clinical Trial Assessing Safety and Pharmacokinetics of Second Innovative Formulation of 5-MeO-DMT

Retrieved on: 
Tuesday, April 5, 2022
Mental Health, Research, FDA, Clinical Trials, Biotechnology, Alternative Medicine, Health, Pharmaceutical, Science, N,N-Dimethyltryptamine, Absorption, Pharmacokinetics, CMO, Research, Beckley Foundation, CEO, 5-Methoxy-N,N-diisopropyltryptamine, Safety, TRD, Depression, FDA, Adsorption, Patient, Volunteering, Pharmaceutical industry

The Phase 1 study is designed as a double-blind, randomised, single ascending dose study to evaluate the safety and pharmacokinetics of BPL-003 in psychedelic-nave healthy subjects.

Key Points: 
  • The Phase 1 study is designed as a double-blind, randomised, single ascending dose study to evaluate the safety and pharmacokinetics of BPL-003 in psychedelic-nave healthy subjects.
  • The study will recruit up to 36 participants (dependent on response) in 6 cohorts of 6 healthy volunteers on increasing doses.
  • A separate Phase 1 study is ongoing, evaluating the safety and pharmacokinetics of BPL-002, a liquid intranasal formulation of 5-MeO-DMT.
  • Dr Frank Wiegand, CMO of Beckley Psytech, said: At Beckley Psytech patients are at the centre of everything we do.

GH Research Reports Full Year 2021 Financial Results and Provides Business Updates

Retrieved on: 
Monday, March 28, 2022
GLOBE, Psychiatry, GHRS, 5-Methoxy-N,N-diisopropyltryptamine, Lists of diseases, MADRS, Research, TRD, Patient, Nasdaq, Pharmaceutical industry

Cash was $276.8 million as of December 31, 2021, compared to $5.9 million as of December 31, 2020.

Key Points: 
  • Cash was $276.8 million as of December 31, 2021, compared to $5.9 million as of December 31, 2020.
  • R&D expenses were $8.6 million for the year ended December 31, 2021, compared to $338 thousand for the full year 2020.
  • G&A expenses were $6.5 million for the year ended December 31, 2021, compared to $108 thousand for the full year 2020.
  • Results of cognitive function tests as well as psychoactive effect assessments were aligned with results of previous trials.