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Cybin: innovating the delivery of psychedelic therapy

The company is investigating novel analogues of psilocybin and DMT to innovate how psychedelic therapies could be delivered.

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Cybin secures patent for psilocybin analogue

CEO of Cybin Inc. Doug Drysdale tells Psychedelic Health about the company’s latest findings on its novel molecules – CYB003 and CYB004.

Cybin has recently announced progress updates for its two lead clinical development programmes.

CYB003 is the company’s proprietary deuterated psilocybin analogue for the potential treatment of Major Depressive Disorder (MDD) and CYB004 is its proprietary deuterated DMT molecule that is being developed for the potential treatment of Generalized Anxiety Disorder (GAD).

Cybin is aiming to revolutionise mental healthcare with these innovative formulations of psychedelic compounds – we speak to Cybin CEO, Doug Drysdale, about the company’s latest data announcement.

CYB003 – novel psilocybin

Interim findings from Cybin’s ongoing Phase 1/2a clinical trial evaluating CYB003 has demonstrated positive observations and the company suggests it may ultimately reduce symptoms of depression after just one or two doses.

Cybin CEO, Doug Drysdale, highlights unique characteristics of the analogue that have been demonstrated in the observations such as a rapid and short-acting psychedelic response in participants, low variability in plasma levels and its ability to induce a psychedelic effect at low doses, while maintaining a safe and well-tolerated therapeutic profile.

For the study, participants received single oral doses of CYB003 at 1 mg, 3mg, 8mg and 10mg, and all doses were well-tolerated with no serious adverse events reported. 

The data also demonstrated that participants reported meaningful and robust psychedelic effects at the 8mg and 10mg doses, confirming that a complete mystical experience was achieved.

“It’s unusual to have a treatment where you can quickly see the effects and when you look across the literature, when you read about people having these very robust psychedelic experiences, or when people will tell you that these experiences fall among the top five most meaningful experiences of their lives, then I think that gets us really excited about what that means in terms of this efficacy study,” said Drysdale.

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“Clearly they have very profound experiences. So, we’re definitely in a phase where we think we’re at the therapeutic dose.”

CYB003 could offer a solution to some of the perceived challenges in implementing psychedelic-assisted psychotherapies in our current healthcare systems.

Traditional psilocybin can last from three to six hours, meaning delivering this therapy in clinical settings will take up a lot of resources, such as staff and therapy rooms. These longer experiences can also make it difficult for some to participate in the therapy due to work and life commitments.

With CYB003 being a fast-acting, short-duration psychedelic compared to a traditional psilocybin experience, the molecule could make the therapy much more cost-effective and accessible for healthcare systems and patients. 

Its novel delivery form may also offer benefits said Drysdale: “It’s an oral – we’re developing a capsule so there’s no need for an IV infusion pump. That makes it really simple to dose. 

“Patients appear to have an onset of effects quite quickly, in 15 minutes or so. Depending on the patient, there are quite robust effects within the range of 30 to 90 minutes or maybe at a couple of hours in that peak state. So, that’s relatively short.”

Drysdale highlights that for some patients with depression, a fast-acting medicine that can see results this quickly is beneficial, as traditional treatments such as SSRIs can take months to work. 

Phase 1 dosing has been completed and the Phase 2a portion of the trial has commenced. Cybin expects to report top-line results from the completed Phase 1/2a clinical trial in late third quarter of calendar year 2023.

CYB004 – novel DMT

Cybin’s DMT analogue – CYB004 – is a scalable and less invasive treatment than traditional DMT. Its Phase 1 CYB004-E trial is evaluating CYB004 in healthy volunteers. 

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The company confirmed in its update that, per a protocol amendment to the initial trial design, it has established a three-part study to include Part A (IV DMT infusion), Part B (IV DMT bolus + infusion) and Part C (CYB004) in healthy volunteers.

This will allow the company to initiate first-in-human dosing of CYB004 sooner than initially planned. Data from the new Parts B and C of the trial will serve to build a more robust pharmacokinetic and pharmacodynamic model to optimise dose selection and formulation development for future clinical studies. 

Part A of the trial evaluating DMT IV in participants is already complete, and IV DMT at the evaluated dose ranges was demonstrated to be safe and well-tolerated. Dosing has now commenced in Part B.

DMT in its native form is not orally bioavailable which means it cannot be delivered in capsule form as CYB003 is.

“What we have done with deuteration is enabled the molecule to be more bioavailable and we have improved the brain penetration,” Drysdale commented. “So, we should be able to formulate that into a small volume that can be given in a more convenient way. This could be intramuscular or subcutaneous injection.” 

“Whereas at the moment we’re studying DMT, and others are as well, using an IV infusion”

IV infusion is not ideal as it requires a line and an infusion pump that needs to be programmed to provide a certain amount of drug over a certain rate of time – needing equipment, a clinical setup and trained personnel – which Drysdale highlights as a major barrier to adoption. 

Cybin’s current study with CYB004 is aiming the understand the right dosing and plasma concentrations, and the relationship between the two and psychedelic effects. A model will be built over the course of the study that will then be translated into a convenient dose form.

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Drysdale said: “One thing we know about DMT is that once the psychedelic effects wear off, it’s cleared from the body fairly quickly. So within 10 minutes or so it’s not traceable. So this could really be a very convenient form for patients and that finally brings them these treatments to the real world.”

Dosing of CYB004 in Part C is expected to begin in early Q2 2023, following the completion of Part B, and Cybin expects to report top-line results from the completed Phase 1 CYB004-E clinical trial in the third quarter of 2023. 

“It is really gratifying to be at this point where, for much of the team who have been working in a lab or working on the more sort of theoretical side of things, to see an idea from a few years ago now being tested in patients,” said Drysdale.

“Around 2000 people die every day from suicide, so this can’t come fast enough. To see the potential for profound effects really quickly is very exciting.”

Join Cybin at PSYCH Symposium

Cybin is a sponsor for PSYCH Symposium: London 2023 which will take place on 6 July at London’s iconic British Museum.

The event will provide audiences with the opportunity to hear exclusive presentations and discussions on stage and to network with leading industry figures.

Cybin’s Chief Medical Officer, Amir Inamdar, will be speaking at the event.

Inamdar is a qualified psychiatrist and pharmaceutical physician with over 20 years of clinical and drug development experience. Previously, he has led clinical drug discovery teams as a medical director for AstraZeneca, Takeda and GlaxoSmithKline.

Get your tickets to PSYCH Symposium: www.psychsymposium.com/tickets

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Research

Landmark UK trial to investigate psilocybin for opioid addiction relapse

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For the first time, a government-funded UK trial will investigate psilocybin-assisted psychotherapy for targetting relapses associated with opioid addiction, aiming to bring an innovative new therapy to the NHS if successful. 

Research shows that the UK had the world’s highest rate of opioid consumption in 2019, amounting to a serious public health concern. Further, figures show that around 140,000 people are accessing treatment for opioid dependence in the country. Despite the prevalence of opioid addiction, there are currently limited medicines to help prevent relapses during recovery.

Led by Imperial College London, the new study will use psilocybin combined with psychological support in people who have recently undergone detoxification from opioids such as heroin, methadone or buprenorphine.

While previous research into psilocybin has shown its potential as a treatment for conditions such as depression, anxiety PTSD and addiction, this is the first trial looking at the medicine for addiction relapse.

See also  Compass Pathways launches Phase 3 psilocybin trial in UK

The study is one of four projects focused on reducing drug deaths that have been funded by the National Institute for Health and Care Research (NIHR) as part of the Addiction Healthcare Goals programme, led by the Office for Life Science (OLS). 

According to the NHIR, the programme forms part of the Department of Health and Social Care’s plan to deliver a world-class treatment and recovery system for people experiencing drug and alcohol addictions.

Dr David Erritzoe, Clinical Director and Deputy Head of the Centre for Psychedelic Research at Imperial College London, project co-lead, said in a press statement: “We know that up to 90% of people relapse back to opioid use within 12 months of finishing detox, so finding new and effective treatments is essential. 

“If this trial is successful, it offers hope for a new type of treatment that could make a significant difference to this group of people.

“If our initial trial is successful, we will work to enable the development of further clinical trials in larger populations, to bring a new treatment to patients and the NHS.”

Participants will attend Imperial’s NIHR Clinical Research Facility at Hammersmith Hospital campus to receive psilocybin-assisted psychotherapy and will receive functional MRI brain scans to enable investigation of the mechanisms of psilocybin in the brain.

Imperial has confirmed that participants will be monitored for up to six months following dosing to track any changes to their opioid use, cravings, mental health outcomes and psychological wellbeing. 

Study co-lead Dr Louise Paterson said in a press statement: “This trial will examine whether we can improve recovery in a severely under-served group of people – namely, those with opioid dependence during their most vulnerable post-detox phase. 

“Clinical studies, including those in our Centre for Psychedelic Research, have shown great promise for this type of treatment in other mental health conditions. We want to see if it works equally well for opioid use disorder.”

Professor Anne Lingford-Hughes, Chair of the Addiction Healthcare Goals, and who is also a Professor of Addiction Biology at Imperial, added: “New approaches to treat drug addiction and reduce drug-related deaths, particularly from overdose, are urgently needed. 

“The Addiction Healthcare Goals programme is pleased to fund promising innovations that have brought together partnerships between industry, academia and organisations involved in delivering treatment and care for those experiencing drug addictions.” 

Recruitment is expected to begin in Spring 2025.

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Psilocybin versus escitalopram for depression shows positive results

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Compass Pathways launches Phase 3 psilocybin trial in UK

A six-month follow-up study of a Phase 2 clinical trial investigating psilocybin versus escitalopram for the treatment of major depressive disorder has shown positive results.

Around 30% of people living with depression in the UK are resistant to current treatments, highlighting an urgent need for new therapies. As the researchers of this study highlight, even for patients who have had their depression successfully treated, there is a high risk of relapse, with one in three patients relapsing within the year.

Equally, SSRI treatments often include side effects such as sexual dysfunction, weight gain, fatigue, and emotional blunting.

The authors note that a key consideration of any treatment of major depressive disorder “is its capacity to produce sustained antidepressant response or remission.”

Mounting evidence is increasingly pointing to psilocybin-assisted therapy as an innovative new treatment for the condition, with clinical trials showing that the therapy is capable of producing rapid and long-lasting antidepressant effects.

However, while clinical trials have investigated the treatment itself, they have not compared the treatment to the current gold standard in depression medications or looked at the long-term effects of the treatment.

This Phase 2 trial is the first to compare the long-term antidepressant effects of these two treatments alongside mental health measures including work and social functioning, connectedness, and meaning in life. 

In the trial, patients with major depressive disorder recruited from a UK hospital were administered either two doses of 25mg of psilocybin along with psychological support, or a six-week course of the selective serotonin reuptake inhibitor (SSRI) escitalopram in combination with psychological support.

The findings, published in eClinicalMedicine, revealed that both administered treatments saw sustained improvements in depressive symptoms, however, patients who were administered psilocybin-assisted psychotherapy saw greater lasting improvements. 

These improvements included psychosocial functioning, meaning in life, and psychological connectedness.

Dr James Rucker, Consultant Psychiatrist & Senior Clinical Lecturer in Psychopharmacology, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, said: “The authors have tended to attribute differences observed in this study to comparative differences between the drugs themselves, however, it is also possible that the results reflect biased reporting between groups. 

“This is more likely here because A) studies involving psilocybin tend to attract those with positive preconceptions about psilocybin and negative preconceptions about conventional antidepressants, and B) study participants were unblinded during the long-term follow-up phase that is reported in the paper, so knew which condition they were allocated to.

“This said, the nature of depression varies hugely between individuals, and this calls for the development of a similarly varied suite of treatment paradigms. Psilocybin therapy is certainly a different paradigm of treatment to escitalopram. 

“The observation of similar levels of effectiveness to antidepressants here is encouraging to see alongside the much larger trials of psilocybin currently underway here in the UK, Europe and the US.”

The authors write: “Key limitations of the study include its suboptimal power to detect small but meaningful differences between treatments, missing data, the potential use of additional interventions during the follow-up period, and reliance on self-reported treatment assessments. 

“These factors may affect the interpretation of the study findings and should be considered when evaluating the results.”

With these considerations in mind, the researchers suggest that the findings warrant further investigation into psilocybin-assisted psychotherapy for the treatment of depression.

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Shortwave Life Sciences psilocybin drug shows positive results in anorexia trial

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Shortwave Life Sciences psilocybin drug positive results anorexia trial

Shortwave Life Sciences has announced it has achieved a significant breakthrough in its ambitions to transform eating disorder care with positive pre-clinical results from its latest pharmacodynamics study, demonstrating the safety of its psilocybin-based drug combination for the treatment of anorexia nervosa.

Anorexia nervosa has one of the highest fatality rates. The condition is a complex mental health condition as well as a metabolic disease, yet no FDA-approved pharmacological treatments are currently available for the condition.

Shortwave Life Sciences in collaboration with Science in Action, an expert pre-clinical GLP-certified lab in Israel, has now tested the safety of buccal administration of Shortwave’s combination drug comprised of psilocybin and a beta-carboline.

The company says this novel treatment provides an expanded mechanism of action and a therapeutic effect superior to psilocybin alone, impacting more than one group of receptors in the brain.

For the study, three groups of rats were given varying doses of the combination drug (0.23ml, 0.5ml, and 1ml), with results showing no adverse effects, weight changes, or behavioural changes following the psychedelic effects.

See also  Short Wave Pharma: innovating eating disorder care with psychedelics

“This is a monumental step forward for Shortwave. Our relentless pursuit of breakthrough mental health treatments comes with the responsibility of ensuring safety at every stage,” commented Shortwave Life Sciences CEO Rivki Stern Youdkevich.

“We are proud of the positive outcomes from this rigorous pre-clinical trial, further validating our patent-pending drug combination and buccal delivery system.

“With this success, we are reaffirmed in our approach to addressing the global mental health crisis.”

In the pre-clinical pharmacodynamics study, all subjects remained healthy and unaffected during the trial, which Shortwave has stated marks a strong foundation for future clinical development.

Furthermore, no adverse events or vital sign changes were reported across all groups, and the results confirmed the safety profile for the psilocybin-based combination drug at elevated doses.

This achievement comes on the heels of the International PCT Examining Committee’s recent acknowledgment of Shortwave’s patent claims for its novel, non-obvious, and industrially applicable mucoadhesive buccal film.

Designed for rapid absorption and bypassing liver and gut degradation, the platform holds transformative potential for patients facing metabolic and psychiatric challenges. This method of administration is designed to be sensitive to patient needs, who may not want to swallow the medicine, and also provides higher bioavailability.

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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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