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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.



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:

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Psilocybin analogue shows positive results in Phase 2 depression study



Psilocybin analogue shows positive results in Phase 2 depression study

Cybin has announced positive Phase 2 topline safety and efficacy data for its proprietary deuterated psilocybin analogue – CYB003 – for the treatment of major depressive disorder (MDD).

Results from Cybin’s study have shown that 79% of patients were in remission from depression at six weeks after receiving two doses of CYB003.

CYB003 demonstrated a large improvement in symptoms after one dose and a total of 79% of patients were responsive to the treatment. The compound also demonstrated an excellent safety profile in doses tested, with all reported adverse events mild to moderate and self–limiting.

Additionally, Cybin has stated that the magnitude of improvement was superior compared to approved antidepressants and recently reported data with other psychedelics, stating that the effects translate into an unprecedented effect size.

The company has said that the results compare favorably to pooled data from 232 industry studies of current standard-of-care antidepressants, SSRIs, submitted to the FDA.

The announcement follows Phase 2 interim results in early November 2023, which demonstrated that CYB003 saw a “rapid, robust and statistically significant reduction in symptoms of depression three weeks following a single 12mg dose compared to placebo”.

Cybin CEO, Doug Drysdale, stated: “We are delighted to share that CYB003 achieved the primary efficacy endpoint in this study and showed rapid and statistically significant improvements in depression symptoms after a single dose, with a clear incremental benefit of a second dose, resulting in four out of five patients in remission from their depression at six weeks.

“This is an impressive finding and follows on from the unprecedented interim results we announced earlier this month.”

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Drysdale emphasised that the strength of the data will support CYB003 into Phase 3 of the study.

Cybin CMO, Amir Inamdar, added: “The significant reduction in depression symptoms observed in our Phase 2 study is highly gratifying.

“At the three-week primary efficacy endpoint, a single 12mg dose of CYB003 showed a rapid, robust, and highly statistically significant improvement in depression symptoms compared to placebo, with a -14.08 point difference in change from baseline in MADRS. 

“This translated into a very large effect size. Similar significant and robust effects were also seen with a single 16mg dose, which resulted in an improvement in symptoms of depression as measured using the MADRS total score by about 13 points versus placebo. 

“These effects were evident on day one with the 16mg dose and were also highly statistically significant. When data from 12mg and 16mg are pooled, these robust effects are maintained. Further, with two doses, response and remission rates in excess of 75% were observed with CYB003 (12mg). 

“With these findings in hand, we are encouraged by the potential of CYB003 to help those with MDD and look forward to progressing to a multinational, multisite Phase 3 study early next year.”

Cybin is planning on submitting topline data to the FDA with an aim to hold a Phase 2 meeting in Q1 of 2024, with further 12-week durability data from Phase 2 CYB003 expected in Q1, and recruitment for the Phase 3 study anticipated to begin by the end of Q1 2024.

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Clerkenwell Health calls for volunteers to support groundbreaking psychedelic research



Clerkenwell Health calls for volunteers to support groundbreaking psychedelic research

Mental health research provider Clerkenwell Health is calling for volunteers to join its groundbreaking clinical trials that will research whether psychedelics can provide effective treatments for complex mental health conditions.

Clerkenwell is seeking a diverse group of volunteers from across the UK between 18 and 65 years old to take part in the trials if they suffer from a relevant condition. 

The trials, which will be conducted at Clerkenwell Health’s purpose-built facility near Harley Street in London, are being run in partnership with a number of world-leading drug developers to test whether psychedelic drugs – often combined with talking therapy – can offer a new approach to treating a variety of mental health illnesses.

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Clerkenwell Health is seeking volunteers for trials that look to find cures for a range of conditions, including PTSD, depression, alcohol use disorder and anorexia. 

Many of the conditions have few successful treatment options and Clerkenwell’s innovative methods of combining psychedelics with therapy aim to to treat these problems more holistically, providing long-term quality of life for patients.

Chief Scientific Officer at Clerkenwell Health, Dr Henry Fisher, said: “With the current system for treating mental health disorders simply not working, we’re calling for patients to help identify the next wave of treatments. 

“These have the potential to be groundbreaking for the millions of people across the UK who are affected by poor mental health.

“The status quo for mental health treatment has not only resulted in patients experiencing debilitating side-effects, huge waiting lists and high relapse rates, but is costly, complicated and broadly ineffective. 

“By participating in upcoming clinical trials, patients have an opportunity to make a valuable contribution to growing research which will support the development of the next generation treatments for mental health conditions.”

According to MIND, approximately 1 in 4 people in the UK will be affected by a mental health condition each year and with a significant rise in people contacting mental health services in recent years, there has never been a more desperate need to identify new and innovative treatments.

Given the challenges facing the country’s health service and with mental health challenges on the rise, the search for volunteers to test effective treatments has never been more pressing. 

Clerkenwell has stated, in this regard, that it has gone national with its search for volunteers in an effort to deliver medical breakthroughs in mental health akin to the Polio clinical trials in the 20th Century.

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Paper explores extended difficulties following psychedelic trips



Paper explores extended difficulties following psychedelic trips

A new paper has explored the extended difficulties experienced by some people following psychedelic drug use and discusses psychedelic harm reduction.

While multiple studies have shown that psychedelics can be safe when administered appropriately, some people experience difficulties following their use. These difficulties can last anywhere from a few days to years.

With a rise in clinical research surrounding these compounds, there is a drive to change drug policy and several places have already implemented progressive approaches to accessing these therapies such as decriminalisation or including them on authorised medical access schemes. 

In light of these developments, it is vital to understand the potential risks associated with psychedelic use and what actions can be taken to reduce these risks.

The paper has been published in Plos One and authored by a team of leading psychedelic scientists from the Universities of Exeter, Greenwich and Queen Mary, University College London and Royal Holloway, New York University and the Perception Restoration Foundation.

Extended difficulties following psychedelic use

The team of researchers has gathered data on the context of use, nature and duration of these difficulties and explored risk factors and perceived causes that may contribute to these experiences. 

The most common forms of extended difficulty that the team uncovered include symptoms such as anxiety/fear and existential struggle, as well as social disconnection, depersonalisation and derealisation.

“For approximately one-third of the participants, problems persisted for over a year, and for a sixth, they endured for more than three years,” the authors write.

The findings revealed that the length of time these experiences last following psychedelic use could be predicted by the participants’ knowledge of dose and drug type, and that the experiences were shorter if a participant had taken part in a guided psychedelic experience. 

Additionally, the most common length of time such difficulties lasted was between one and three years. When asked about mental illness onset following the psychedelic experience, 18.8% said they had gone on to be diagnosed with a mental illness, while 76.8% said they had not.

The authors write: “Our findings support the results of Simonsson et al., who found that anxiety was the most common enduring difficulty, based on quantitative questionnaire data and Bouso et al’s study of the Global Ayahuasca Survey, in which ‘feeling nervous, anxious or on edge’ was the second most common adverse mental health effect. Our findings also suggest that a Sense of disconnection from others was within the top five most prevalent themes, as did the studies by Simonsson et al. and Bouso et al. 

“Some extended adverse effects that were quite common in other studies weren’t so common in our data set–for example, feeling a harmful connection to the spirit world was reported by 14% of respondents to the Global Ayahuasca Survey but by less than 4% of our data set, which may suggest some forms of difficulty are particularly associated with certain psychedelic substances and/or their associated cultures.”

Reducing risk factors

The authors suggest a number of actions that could be taken to reduce these risks.

Highlighting that, as anxiety and fear are some of the most commonly reported difficulties, the authors suggest that all legal psychedelic experience providers give guidance on methods for “self-soothing and overcoming bouts of anxiety following the retreat, clinical trial or ceremony.”

Further suggestions include informing participants of potential harms and risks and advising participants that the integration process may take some time, and what practices can be done to help people cope with difficulties. The authors say these practices will be explored in an upcoming paper.

The team writes: “We envisage using the information in this study, and accompanying future papers that focus on social support and forms of coping used by those with enduring difficulties, to provide structured guidance and training to psychedelic retreats, therapists and clinical trial centers about the potential for adverse experiences, what the potential risk factors are and what can be done to help individuals who report such extended difficulties.”

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