Beckley Foundation

Beckley Psytech announces positive initial data from Phase IIa study of novel 5-MeO-DMT formulation BPL-003 for Treatment Resistant Depression

Retrieved on: 
Wednesday, March 27, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Mental Health, Clinical Trials, Other Health, Depression, Atypical depression, Data analysis, MDD, Patient, Beckley Foundation, DSM-IV codes, TRD, Treatment, Drug development, Safety, Phase, FDA, 5-MeO-DMT, Pharmaceutical industry

95% of events were mild or moderate, and no serious adverse events were reported which is broadly consistent with Phase I findings .

Key Points: 
  • 95% of events were mild or moderate, and no serious adverse events were reported which is broadly consistent with Phase I findings .
  • Acute effects were resolved and patients were deemed dischargeable within an average time of less than 2 hours.
  • Our single dose treatment model enables a short treatment duration which positions BPL-003 as a potentially exciting and scalable treatment opportunity.
  • The company’s lead compound, BPL-003, is a novel, synthetic 5-MeO-DMT benzoate salt candidate currently under investigation for the treatment of Treatment Resistant Depression (TRD) and Alcohol Use Disorder (AUD).

Beckley Waves Celebrates a Year of Milestones, Including $3.3 Million in New Funding, 200 Retreat Participants, the Inaugural Cohort of Therapist Training, and the Acquisition of Ketamine Therapy Provider Nue Life

Retrieved on: 
Tuesday, March 5, 2024
Psilocybin, Mental health, Woman, ICL, Research, Beckley Foundation, Suicide, Spirituality, Curriculum, Entrepreneurship, MDMA, BIPOC, Ketamine, Veteran, PAT, Imperial College London, Partnership

Through its portfolio of operating companies, Beckley Waves has also expanded programs for practitioner training and psilocybin retreats, accelerating the company’s growth.

Key Points: 
  • Through its portfolio of operating companies, Beckley Waves has also expanded programs for practitioner training and psilocybin retreats, accelerating the company’s growth.
  • In September, the company also acquired at-home ketamine therapy provider Nue Life and will continue Nue Life’s work to provide safe and scalable access to ketamine-assisted therapy in underserved areas across multiple US states.
  • In 2024, Beckley Retreats will offer dedicated retreats in Jamaica and the Netherlands that will be exclusively for women, veterans, and the BIPOC community.
  • "With our ongoing momentum, we will keep the flywheel spinning and continue to allow the Beckley Waves Ecosystem to play a catalytic role in our shared path to widespread access."

Beckley Academy Welcomes New Faculty for 2024 Psychedelic Therapy Practitioners Courses

Retrieved on: 
Thursday, December 14, 2023
Veteran, Faculty, Beckley Foundation, LCSW, Woman, MAPS, Research, Cognitive behavioral therapy, Ketamine, Psilocybin, LPC, Social justice, CIIS, MDMA, Refugee, PTSD, Human, Course, Patient, Safety, PAT, BIPOC, Education, Nursing

Both Sara and Mary are psychedelic therapists with clinical experience working with training organizations to meet the increasing demand for experienced and credentialed therapists able to train practitioners in the administration and facilitation of psychedelic therapies.

Key Points: 
  • Both Sara and Mary are psychedelic therapists with clinical experience working with training organizations to meet the increasing demand for experienced and credentialed therapists able to train practitioners in the administration and facilitation of psychedelic therapies.
  • Mary has completed training at CIIS CPTR, MAPS, and the Ketamine Training Center and is certified in Trauma-Focused Cognitive Behavioral Therapy.
  • Sara Gael Beauregard, MA, LPC, is a psychedelic therapist, educator, and mentor with expertise in MDMA-Assisted Therapy, ketamine-assisted therapy, and psychedelic risk reduction.
  • At Beckley Academy, we foster the relationship between learners and faculty by approaching the online classroom as a time for rich discussion, reflection, and embodied skills practice,” said Deborah Gardner , Head of Education for Beckley Academy.

First Patient Dosed in Beckley Psytech’s International Phase IIb Study of BPL-003, a Novel Synthetic Intranasal Formulation of 5-MeO-DMT, for Treatment Resistant Depression (TRD)

Retrieved on: 
Tuesday, October 24, 2023
Alternative Medicine, Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, FDA, United Kingdom, MADRS, IND, Food, Treatment, Investigational New Drug, Maintenance, Drug development, Atypical depression, Clinical trial, Depression, Safety, Patient, DSM-IV codes, TRD, Beckley Foundation, Pharmaceutical industry, Radiant exposure

It follows Beckley Psytech’s receipt of the U.S. Food and Drug Administration’s (FDA) first ever Investigational New Drug (IND) approval for a Phase IIb study of a short-acting psychedelic compound in February this year.

Key Points: 
  • It follows Beckley Psytech’s receipt of the U.S. Food and Drug Administration’s (FDA) first ever Investigational New Drug (IND) approval for a Phase IIb study of a short-acting psychedelic compound in February this year.
  • The study will be quadruply masked, with the patient, investigator, therapist and outcomes assessor all masked to the dose allocation of the subject in order to reduce expectancy bias.
  • The doses for this Phase IIb study were selected after Beckley Psytech’s preclinical and Phase I studies showed BPL-003 to be well-tolerated with a predictable dose-linear pharmacokinetic profile.
  • Beckley Psytech has partnered with Fluence to provide training for the standardised psychological support that will be offered to patients in the trial.

The Trip Report by Beckley Waves Launches The Trip Report Podcast

Retrieved on: 
Thursday, August 3, 2023
Depression, Amanda Feilding, Policy, Beckley Foundation, Research, Science, Trip, City, FDA, Society, PTSD, Nightclub, Pharmaceutical industry

The Trip Report newsletter and new podcast aim to foster an educated and informed psychedelic ecosystem, and newsletter readership has grown 100% in the past year.

Key Points: 
  • The Trip Report newsletter and new podcast aim to foster an educated and informed psychedelic ecosystem, and newsletter readership has grown 100% in the past year.
  • Guests for season one of The Trip Report podcast include:
    The Trip Report Podcast and newsletter are a production of Beckley Waves, a venture studio co-founded by psychedelic science and policy pioneer Amanda Feilding.
  • The Trip Report by Beckley Waves, following in the footsteps of Amanda Feilding, stems from her pioneering research and instrumental contributions through the Beckley Foundation, which has also been on the forefront of reshaping global drug policy.
  • “We’re very excited to launch The Trip Report Podcast as a supporting role in the overall mission of Beckley Waves,” said Zach Haigney, host of The Trip Report.

Beckley Waves Establishes Ethics Council to Guide Industry Standards and Best Practices During Inaugural Summit of The World’s Leaders in Psychedelics

Retrieved on: 
Thursday, June 1, 2023
Partnership, German Ethics Council, Beckley Foundation, Economist, Indigenous peoples, Indigenous, Science, Ethics, MAPS, Knowledge, Growth, Mental health, Consciousness, Safety, Medical device, Nightclub, Nursing

LONDON, June 01, 2023 (GLOBE NEWSWIRE) --  Beckley Waves, the first venture studio explicitly formed to build and invest in the thriving psychedelic ecosystem and advance mental health and well-being, has announced the formation of a new Ethics Council to help guide wider industry standards and best practices in the psychedelics sector.

Key Points: 
  • The inaugural meeting hosted by Beckley Waves was led by Amanda Feilding, founder and executive director of the Beckley Foundation.
  • Beckley Waves is helping to foster a flourishing psychedelic industry, harnessing Amanda Feilding’s historic legacy to pave the way for the continued psychedelic renaissance.
  • “While the psychedelics industry is in its infancy, these compounds and practices have been used for millennia by Indigenous peoples.
  • We hope that others will join us in working to these standards.”
    For more information about Beckley Waves and their commitment to the psychedelics industry, please visit www.beckleywaves.com .

Beckley Psytech initiates Phase IIa study of 5-MeO-DMT candidate BPL-003 for Alcohol Use Disorder

Retrieved on: 
Wednesday, April 5, 2023
Biotechnology, Technology, Health, Pharmaceutical, Mental Health, Health Technology, Other Technology, Medical Devices, Research, Science, Clinical Trials, Drug development, Phases of clinical research, Beckley Foundation, Pharmacokinetics, King's College London, DSM-IV codes, University College London Hospitals NHS Foundation Trust, Death, AUD, MDD, Patient, Atypical depression, King, FDA, TRD, Treatment, Safety, Major depressive disorder, Pharmaceutical industry

Beckley Psytech Ltd, a private, clinical-stage biotechnology company dedicated to addressing neuropsychiatric disorders by transforming psychedelics into effective and licensed medicines, today announced that it has initiated a Phase IIa study ( NCT05674929 ) investigating its lead candidate, BPL-003, as a potential treatment for alcohol use disorder (AUD).

Key Points: 
  • Beckley Psytech Ltd, a private, clinical-stage biotechnology company dedicated to addressing neuropsychiatric disorders by transforming psychedelics into effective and licensed medicines, today announced that it has initiated a Phase IIa study ( NCT05674929 ) investigating its lead candidate, BPL-003, as a potential treatment for alcohol use disorder (AUD).
  • Beckley Psytech’s Phase IIa study, taking place at King’s College Hospital in London, will explore the safety, efficacy and pharmacokinetics of BPL-003 in patients diagnosed with alcohol use disorder (AUD).
  • Alcohol use disorders are estimated to affect around 237 million people across the globe , with 3 million deaths each year attributed to the harmful use of alcohol.
  • Cosmo Feilding Mellen, CEO of Beckley Psytech, said: “There is increasing evidence demonstrating the therapeutic effect of psychedelics for substance use disorders.

Beckley Psytech receives FDA Investigational New Drug (IND) approval for Phase IIb study of BPL-003, a novel synthetic formulation of 5-MeO-DMT (Mebufotenin)

Retrieved on: 
Tuesday, February 21, 2023
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Mental Health, Clinical Trials, Safety, TRD, Depression, Investigational New Drug, Drug development, Treatment, Selective serotonin reuptake inhibitor, IND, Major depressive disorder, Patient, Beckley Foundation, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Atypical depression, AUD, MADRS, DSM-IV codes, MDD, Food, Phase, 5-MeO-DMT, Pharmaceutical industry

BPL-003 is Beckley Psytech’s novel synthetic formulation of the psychedelic compound 5-MeO-DMT (also known as Mebufotenin) and is administered intranasally via an FDA-approved delivery device.

Key Points: 
  • BPL-003 is Beckley Psytech’s novel synthetic formulation of the psychedelic compound 5-MeO-DMT (also known as Mebufotenin) and is administered intranasally via an FDA-approved delivery device.
  • This IND marks the first time the FDA has ever given IND approval for a Phase IIb study of a short-acting psychedelic treatment or a 5-MeO-DMT treatment.
  • The study will be conducted with the help of 40 investigator sites in 7 different countries and is due to be initiated in H1 2023.
  • Phase I data has already shown BPL-003 to be well-tolerated with consistent dose delivery and a reproducible, dose-linear pharmacokinetic profile.

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

Retrieved on: 
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

Retrieved on: 
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.