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Groundbreaking psilocybin study results show promise for depression

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Groundbreaking psilocybin study results show promise for depression

The largest psilocybin therapy clinical trial ever conducted, investigating psilocybin for treatment-resistant depression (TRD), has achieved its primary endpoint.

COMPASS Pathways has announced that its randomised, controlled, double-blind phase IIb trial of psilocybin therapy for TRD has achieved its primary endpoint for the highest dose. A 25mg dose of the compound – COMP360 – demonstrated a highly statistically significant and clinically relevant reduction in depressive symptom severity after three weeks, with rapid and durable treatment response.

The objective of the trial was to find the appropriate dose for a larger, pivotal phase III programme, which COMPASS expects to begin in 2022.

David J Hellerstein MD, commented: “Treatment-resistant depression is a common and devastating condition, affecting tens of millions of people, with few effective treatments. This is the largest modern study of a psychedelic drug, combined with psychological support, enrolling over 200 people with TRD. 

“In this groundbreaking study, a single dose of psilocybin, given in conjunction with psychological support, generated a rapid response that lasted up to 12 weeks. Remission rates appear to be higher than seen in traditional medication studies. 

“We now have evidence from a large well-designed trial that psilocybin may be effective for people with treatment-resistant major depressive disorder. These findings suggest that COMP360 psilocybin therapy could play a major role in psychiatric care, if approved.”

See also  Majority in favour of changing law to boost psilocybin research in UK

In the trial, all patients discontinued antidepressants prior to participation, and the trial was powered to compare two active doses of COMP360, 25mg and 10mg, against a comparator 1mg dose. 

The 25mg group versus the 1mg group showed a -6.6 difference on the Montgomery-Asberg Depression Rating Scale (MADRS) depression scale at week three, and the 25mg group demonstrated statistical significance on the MADRS efficacy endpoint on the day after the COMP360 psilocybin administration. The 10mg vs 1mg dose did not show a statistically significant difference at week three.

COMPASS said that at least twice the number of patients in the 25mg group showed response and remission at week three and week 12, compared with the 1mg group: “The protocol-defined sustained response up to week 12 was double, with 20.3 per cent of patients in the 25mg group vs 10.1 per cent in the 1mg group. Using a definition of sustained response that is consistent with other TRD studies, the difference was more than double, with 24.1 per cent of patients in the 25mg group vs 10.1 per cent in the 1mg group.”

CEO and co-founder, of COMPASS, George Goldsmith, said: “No one is untouched by the mental health crisis – everyone has a story. We urgently need options for people who are not helped by existing therapies. We set out to explore the safety and efficacy of COMP360 psilocybin therapy in treatment-resistant depression, through a rigorous and large-scale trial, and to find an appropriate dose to take to the next stage. 

“I am delighted that we have succeeded in doing this. We have demonstrated our ability to execute an innovative, multicentre, multinational clinical trial programme – and in the midst of a global pandemic.  

See also  UK continues to delay on psilocybin rescheduling

“Our work follows the efforts and achievements of so many researchers before us, and we are grateful to all of them and for the opportunity to work with the mental health care community to transform patient experience and patient outcomes. 

“With our world-leading psychedelic research over the last few years, we have now created a unique and extensive data lake; this provides an unprecedented opportunity to further evaluate and optimise psilocybin therapy for patients suffering with serious mental health illness. With these compelling data, we will urgently progress our clinical development programme and move closer to making this therapy accessible to patients in need, if approved.”

The company added that COMP360 was generally well tolerated, with more than 90 per cent of treatment-emergent adverse events (TEAE) being mild or moderate in severity. 179 patients reported at least one TEAE; the most common TEAEs across treatment groups were headache, nausea, fatigue and insomnia. 

There were 12 patients who reported treatment-emergent serious adverse events (TESAEs). These TESAEs included suicidal behaviour, intentional self-injury, and suicidal ideation, which are regularly observed in a treatment-resistant depression patient population, and which occurred more frequently in the 25mg group than in the 10mg or 1 mg groups. Overall, 209 patients completed the study; there were five withdrawals from the 25mg group, nine from the 10mg, and 10 from the 1mg.

Robin Carhart-Harris PhD, Director of the Psychedelics Division at the Weill Institute for Neurosciences at the University of California San Francisco, and Ralph Metzner Distinguished Professor of Neurology, Psychiatry and Behavioral Sciences, said: “This is an important and exciting moment for the mental health care community. 

“It builds upon more than two decades of research into the viability of psychedelic compounds to treat mental health conditions and demonstrates the potential it has in helping people living with treatment-resistant depression. It’s encouraging to see how far this field has progressed in the last 20 years and I look forward to further research.”

COMPASS is conducting comprehensive secondary analyses which are expected to further inform the clinical development programme for COMP360 psilocybin therapy.

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Psychedelics for addiction research gets $2.7m grant

The grant will fund research to investigate the efficacy of psychedelics for treating a variety of addiction disorders.

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Psychedelics for addiction research gets $2.7m grant

The University of California, Davis (UC Davis) and the University of Colorado Anschutz Medical Campus have received a $2.7m (~£2.15m) grant from the National Institute on Drug Abuse, part of the National Institutes of Health, to research psychedelics.

The researchers will use the funding to screen hundreds of compounds to discover new, non-hallucinogenic treatments for substance use disorders. 

With previous research having shown that psychedelic drugs can rewire parts of the brain involved in depression, substance abuse and post-traumatic stress disorder, David Olson, associate professor in the departments of Chemistry, and Biochemistry and Molecular Medicine at UC Davis, is searching for similar effects among compounds without the hallucinogenic effects of drugs like LSD. 

He calls these compounds psychoplastogens, for their ability to modify the brain.

See also  World’s first study on ketamine for behavioural addiction now complete

Olson commented: “I’m very excited that NIDA is recognising the potential that psychoplastogens might have for patients with substance use disorders.

“This grant will help us to understand the basic mechanisms by which these compounds impact addiction, and hopefully develop more effective and better-tolerated treatments.”

Olson’s work is part of a growing focus on psychedelics research at UC Davis and UC Davis Health. His lab has synthesised hundreds of molecules related to psychedelics in the search for new drug therapies. 

One such molecule, tabernanthalog, or TBG, produces both rapid and sustained anti-addictive effects in rodent models of heroin and alcohol self-administration.

The research will include mechanistic studies to understand how TBG impacts addiction and the development of new compounds with psychoplastogenic effects, he said. The team will use high-throughput screening to test for efficacy, safety and treatment potential. Promising compounds will undergo additional animal testing at CU Anschutz.

Delix Therapeutics, a startup founded by Olson, is also investigating non-hallucinogenic psychoplastogens for treating depression, anxiety and related disorders but is not involved in the project.

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World’s first study on ketamine for behavioural addiction now complete

Awakn Life Sciences will now carry out a larger study following positive results.

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World’s first ketamine for behavioural addiction study now complete

Awakn Life Science’s study exploring the use of ketamine as a treatment for Gambling Disorder, Internet Gaming Disorder, Binge Eating Disorder and Compulsive Sexual Behavior is now complete.

Ketamine may provide a new treatment solution for behavioural addictions, according to the study researchers.

Gambling Disorder, Internet Gaming Disorder and Binge Eating Disorder affect up to 450 million, 235 million and 100 million people across the globe respectively. Compulsive Sexual Behavior affects up to 350 million people. 

Awakn, which highlights that the current standard of care for these conditions is poor, investigated ketamine as a new treatment approach for behavioural addictions by opening a window in which the brain can make new connections to change behaviour. 

See also  Awakn initiates first ever ketamine treatment study for gambling addiction

The findings indicated the desired effects via potentially novel mechanisms – results that merit a larger study and further exploration, which Awakn is now initiating.

The study was led by Professor Celia Morgan, Awakn’s head of ketamine-assisted therapy, Professor of psychopharmacology at the University of Exeter, and an internationally respected expert in the therapeutic use of ketamine. 

Morgan commented: “These promising early findings may suggest a new treatment solution in behavioural addictions, which are growing rapidly across the globe, and as yet, are a completely unmet treatment need. 

See also  Groundbreaking ketamine study receives approval for expansion

“The team are excited to be starting these new significant studies which promise to bring considerable innovation to the field.”

According to Awakn, the study also supports its Intellectual Property (IP) strategy and existing filed patent applications.

Awakn CEO, Anthony Tennyson commented: “This study is hugely encouraging and gave us all the data we could have hoped for. Critically, it also showed us that a larger study is merited, and we will now pursue this. 

“For such a huge cohort of over a billion people to be suffering with no pharmacological treatment available to them, is unacceptable and we will strive to deliver therapies to patients who are in desperate need.”

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New partnership to harness digital tools to enhance psychedelic care

Beckley Psytech is entering into a partnership with Empatica to carry out one of the world’s first trials with psychedelics and digital tools.

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New partnership to advance personalised psychedelic patient care

Beckley Psytech and Empatica are collaborating to support the collection and analysis of data in Beckley Psytech’s future clinical trials.

The partnership will capture behavioural and physiological signals and predictive biomarkers in Beckley Psytech’s upcoming Phase 2 clinical trials. To do this, Beckley Psytech will harness Empatica’s medical-grade EmbracePlus wearable and software.

The trials will be evaluating the use of 5-MeO-DMT in combination with psychotherapy in the treatment of treatment resistant depression (TRD).

See also  Beckley Psytech doses first patients in novel 5-MeO-DMT study

Empatica, Inc., specialises in medical wearables and digital biomarkers, offering continuous, passive and unobtrusive monitoring for patients with neurological conditions. Beckley has stated the partnership is the latest step in its digital strategy to develop personalised treatment programmes for patients in need. 

The digital enhancement of the psychedelic treatment pathway aims to support patients before, during and after treatment through the application of novel, predictive biomarkers which will potentially identify early signals of patient response and relapse.

CEO of Beckley Psytech, Cosmo Feilding Mellen, said: “As we look to enhance the safety and effectiveness of our psychedelic treatments with patient-centric digital tools, this partnership with Empatica accelerates our strategy of creating an integrated treatment model to ensure patients are fully supported through the treatment journey. 

See also  Beckley Psytech collaboration to develop next-gen psychedelic medicines

“We are thrilled to be working with Empatica, a pioneering digital health company, through our upcoming clinical trials and look forward to further evolving our understanding of how digital tools can support and potentially improve outcomes for patients with neurological and psychiatric conditions.”

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. 

The company has stated that this approach will allow clinicians to provide patients with continuous access to personalised therapy support beyond their treatment, delivering potentially improved outcomes and safety for patients and healthcare systems.

Matteo Lai, CEO of Empatica, commented: “We couldn’t be more excited to collaborate with Beckley Psytech on this important project, especially since over the past two years, we have witnessed how critical mental health and depression have become globally. 

“The potential of psychedelic treatments in the field can help millions of patients, and Empatica is honoured to contribute its technology in one of the world’s first trials with psychedelics and digital tools, to advance these novel therapies with targeted help and better engagement.”

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Psychedelic Health is a journalist-led news site. Any views expressed by interviewees or commentators do not reflect our own. We do not provide medical advice or promote the personal use of psychedelic compounds. Please seek professional medical advice if you are concerned about any of the issues raised.

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