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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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SRI and non-SRI patients experience similar antidepressant effects of psychedelics



SRI non-SRI patients similar antidepressant effects psychedelics

A new study has shed light on the impact of psychedelics in patients taking SRIs, finding similar antidepressant effects as those not taking SRIs.

Increasing research is showing that psychedelics hold promise as potential new treatments for mental health conditions. However, how psychedelics interact with commonly prescribed antidepressants – serotonin reuptake inhibitors (SRIs) – is largely unknown.

This is a barrier to the advancement of psychedelics as mental health treatments, as those who may need these treatments the most are likely to be taking, or have taken at some point, SRIs.

Typically, due to this lack of knowledge on the safety of taking psychedelics when on antidepressants, many participants of clinical trials are required to stop using them for two weeks before taking part in a trial.

Additionally, some research has suggested that those taking SRIs may experience less therapeutic effects from psychedelics, such as psilocybin, than those who have never taken them. For example, one study found that patients who had been taking the antidepressant Escitalopram experienced fewer therapeutic effects than those who had not.

Now, a new survey study of people using psychedelics in real-world settings has investigated the interaction between these two medicines, comparing the acute psychedelic effects and subsequent changes in wellbeing and depressive symptoms in those on psychiatric medication and those who are not. 

SRI vs non-SRI

For this study, the team analysed the subjective differences and changes in wellbeing and depressive symptoms in participants both before and after the psychedelic experiences.

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They found that patients who were not taking SRIs experienced significantly more intense subjective effects than those who were not. This group also experienced stronger mystical experiences and more challenging emotional breakthrough experiences.

However, they also found that both groups had similar drug-induced visual experiences.

Importantly, they found that the group who were taking antidepressants reported similar improvements in wellbeing and depressive symptoms following the psychedelic experience to those who were not taking them. 

Speaking to Psychedelic Health, study co-lead Tommaso Barba, at the Centre for Psychedelic Research, Imperial College London, commented: “I think we don’t have a definitive answer yet, the combination seems to work and it seems to induce a therapeutic response, if this response is lower than on people who are not on these drugs is still a sort of open question. 

“Our study suggests it’s not lower, but it’s a naturalistic survey study, with overall small sample and lack of laboratory controls.”

Barba points to a study that suggests people on SRIs have reduced intensity of the acute psychedelic experience, but notes this only occurred in half of the participants, and highlights another study that showed that psilocybin therapy seems efficacious in patients that were also using SRIs, as the reductions in depression were comparable to another study that involved patients who were not on medications.

“What is lacking now is a randomised trial in which two groups, one on SRI and one not, are directly compared in laboratory settings,” said Barba.

“I think that the current evidence, with other results, show that taking people off SRIs before psilocybin therapy was associated with reduced therapeutic efficacy compared to people who were unmedicated at the entrance of the trial, suggesting that discontinuing medications is not warranted, and maybe people are not required to do so and could be kept on them.”

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In their paper, the research team concludes that: “Individuals presumed to be on serotonergic antidepressants during psychedelic use display reduced subjective effects but similar antidepressant effects compared to those not undergoing SRI treatment.

“Further controlled research is needed to comprehend the interplay between serotonergic antidepressants and psychedelics, illuminating potential therapeutic benefits and limitations in clinical contexts.”

For example, serotonin has been implicated in several major psychiatric disorders, with low levels contributing to conditions such as depression. SRIs work by making more serotonin available in the brain.

As highlighted by Thomas and Malcolm in a 2022 paper, mental health conditions that are targeted by psychedelic medicines are most often managed with SRIs, “so it is important to evaluate the potential risks of drug-drug interactions and serotonin toxicity (ST) between these agents.”

Serotonin toxicity is a condition that is often induced when two or more serotonin-elevating drugs are used in combination. The condition leads to too much serotonin within brain synapses and can sometimes be life-threatening, causing symptoms such as seizures, irregular heartbeat and unconsciousness.

Thomas and Malcolm emphasise that due to the ability of psychedelics and SRIs to increase serotonin, some combinations may present a significant risk of serotonin toxicity.

In this survey study, the researchers highlight that only two modern studies have investigated the interaction between SRIs and psychedelics which have presented partially contradictory results.

The team has also emphasised that their findings could have implications for modifying research design and inclusion criteria for certain clinical studies, as well as for informing future medical use of psychedelics in order to maximise positive outcomes and the efficacy of the treatments.

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The study team included leading psychedelic researchers Tommaso Barba, Jessica Barbut Siva and Hannes Kettner at the Centre for Psychedelic Research, Imperial College London; Joanna Kuc, Experimental Psychology, University College London; Professor Robin Carhart-Harris, Ralph Metzner Distinguished Professor in the Department of Neurology at the University of California, San Francisco; Dr David Erritzoe, Clinical Director in Centre for Psychedelic Research & Clinical Senior Lecturer in Psychiatry at Imperial College London; Professor David Nutt, Professor of Neuropsychopharmacology at Imperial College London.

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Psychedelic research secures first-ever European Union grant of €6.5 million



Psychedelic research secures first-ever European Union grant of €6.5 million

Marking a historic first for Europe, the European Union has funded research into psychedelic therapy as part of its Horizon Europe programme. 

The EU has awarded €6.5 million to a consortium of 19 partners from nine different European countries for a clinical trial – the PsyPal trial.

The trial will study psilocybin-assisted psychotherapy for psychological and existential distress in people who are diagnosed with either chronic obstructive pulmonary disorder (COPD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) or atypical Parkinson’s disease (APD). 

The consortium includes psychiatrists, palliative care physicians, psychologists, experts in psilocybin therapy, researchers focusing on spiritual care and representatives from religious institutions. 

Throughout the trial, the PsyPal consortium will be engaging with the Psychedelic Access and Research Europe Alliance (PAREA), a non-profit reform group that has been campaigning for access to psychedelic therapy in Europe.

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Tadeusz Hawrot, Executive Director of PAREA, told Psychedelic Health: “I couldn’t be happier with this development. Advocating for EU-funded research on psychedelics is part of PAREA’s DNA. 

“It is particularly crucial to explore their potential in areas with significant unmet mental health needs, where commercial interest is lacking, such as in palliative care. With a growing body of promising results in the medical use of psychedelics, what we urgently need now are more European multisite studies. 

“We require clinical trials involving larger and more diverse patient populations to further establish their efficacy and safety. Generating more clinical data on the safety and efficacy of psychedelic compounds will pave the way for the marketing authorization process in Europe, accelerating the delivery of these medicines to patients who are often in desperate need of more treatment options.

“Jeremy Farrar – a former Director of Wellcome Trust and current WHO Chief Scientist – once said about Horizon Europe that it is globally regarded as the best internationally co-operative endeavor anywhere in the world. 

“Importantly, this new EU project will not only advance our understanding of psychedelic therapies but also help establish psychedelics as legitimate, emerging mental health treatments.”

The PsyPal Trial

Following in the footsteps of previous research which has demonstrated the potential benefits of psychedelic-assisted therapy for people living with terminal cancer, the study is the first clinical trial to investigate the safety and effects of psilocybin in non-oncology palliative care patients.

The trial will be led by the University Medical Centre Groningen (UMCG) in the Netherlands in collaboration with HumanKindLabs and will begin early this year. Locations for the trial include the UMCG, the Champalimaud Foundation in Portugal, the National Institute of Mental Health in the Czech Republic, and the University of Copenhagen and the Bispebjerg Hospital in Denmark. 

During the trial, participants will take part in two psychedelic therapy sessions – receiving either psilocybin or a placebo. 

In a statement, Robert Schoevers, head of psychiatry at the UMCG and principal investigator of PsyPal, stated: “We are eager to see if we can ease the suffering of these patients whilst also examining longer-term patient and family outcomes of this treatment, something that often gets overlooked but that is of enormous importance.” 

As well as immediate clinical outcomes, the trial will be studying whether or not the therapy can help sustain the well-being of patients and their families post-treatment. 

The trial will utilise peer support and online tools to “enhance coping mechanisms and alleviate distress as people approach the end of their lives.”

Horizon Europe

Established in 2021 the Horizon Europe programme was launched to accelerate research and innovation in Europe and is running with a budget of €95.5 billion.

Schoevers added: “We are absolutely thrilled that the EU is supporting this ambitious collaborative study. There is growing recognition that psychedelic treatments may help patients for whom alternatives are not effective, and I am very glad we are receiving support from this highly prestigious funding program. 

“It really helps to strengthen the collaboration between researchers from different countries and disciplines, focusing on potentially transformative interventions for severe, currently treatment-resistant mental disorders.” 

Principal investigator Robert Schoevers (UMCG) attends a patient receiving psychedelic-assisted therapy.’ 

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First psilocybin trial for bipolar depression shows promising results



First psilocybin trial for bipolar depression shows promising results

The first-ever psilocybin trial for treatment-resistant bipolar type II disorder has shown 80% of participants meeting remission criteria 12 weeks after treatment.  

JAMA Psychiatry recently published results from the first-of-its-kind clinical trial conducted at Sheppard Pratt. The study explored the efficacy and safety of a single dose of synthetic psilocybin accompanied by psychotherapy in treating individuals with treatment-resistant bipolar type II disorder (bipolar II). 

The 12-week, open-label trial, initiated and led by Scott T. Aaronson, chief science officer of the Institute for Advanced Diagnostics and Therapeutics at Sheppard Pratt, and funded by Compass Pathways, included 15 participants aged 18 to 65 with treatment-resistant bipolar II. 

Each participant had experienced an episode of bipolar II for a period greater than three months and documented at least two failed pharmacological treatments within the current episode. 

After discontinuing psychotropic medications at least two weeks prior to the trial, participants were administered a single dose (25mg) of synthetic COMP360 psilocybin in a controlled setting. 

Therapists held sessions with patients during the eight-hour dosing day as well as for three sessions prior to the trial’s start and for three integration sessions post-treatment. Funding for the study will also allow for patient results to be monitored up to two years following treatment.

Aaronson stated: “The results we saw from this trial are encouraging and further support the clinical study of psychedelics in patients with treatment-resistant bipolar II.

”One participant compared the transformation she experienced to taking a deep breath after breathing through a straw for years. These are the types of stories we are hearing from people who struggled with this disorder for years, many whom had lost hope that their bipolar II could ever be treated.”

In this small pilot study, there were no findings that patients had developed symptoms of psychosis during treatment and 73% of participants met remission criteria on the Montgomery Asberg Depression Rating Scale three weeks post-treatment. 

A total of 80% also experienced remission with no increase in bipolar II symptoms such as mania, hypomania, or suicidality twelve weeks after treatment. The results of this study suggest the efficacy and safety of psilocybin in treatment of bipolar II depression, but cannot be extrapolated to the study of psilocybin to treat bipolar I disorder.

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