Connect with us


Clerkenwell Health: Developing a gold standard for psychedelic care

Clerkenwell Health is aiming to accelerate the development of efficacy data and help deliver psychedelic clinical trials at speed and scale.



UK sees crossparty call to review scheduling of psilocybin

UK company Clerkenwell Health is working to develop a gold standard in the delivery of psychedelic care.

Clinical trial company Clerkenwell Health is embarking on institutional partnerships to conduct psychedelic research and drug development, helping psychedelic compound manufacturers commercialise their products. The company is also building the first custom-designed Centre of Excellence for psychedelic clinical trials.

By focusing its research on the benefits of therapy alongside supportive technologies, Clerkenwell aims to create a best-in-class, regulatory approved framework for delivering psychedelic-assisted psychotherapy. 

Clerkenwell CEO Tom McDonald and CSO Dr Henry Fisher spoke to Psychedelic Health about its plans to accelerate the development of efficacy data and help deliver psychedelic clinical trials at speed and scale.

Set and setting for optimal patient outcomes

Clerkenwell is setting up its Centre of Excellence in 2022,  which will be built with set and setting in mind – aiming to create beautiful spaces that will optimise outcomes for patients. 

McDonald commented: “There has been a bit of a shift over the past 15 to 20 years towards more speciality clinical research outfits and we think psychedelics, in particular, are really relevant for this. 

“Typically, trials at the moment – be they for oncology or viruses, or now, psychedelics and mental health – they are typically taking place in pretty unpleasant looking environments. So, out of the back of a university hospital is really the option that companies have got here in the UK at the moment. 

See also  Partnership to advance patient access to psychedelics in Europe

“We will be creating a really beautiful setting – more akin to the priory than a university hospital – out in a nice remote place. The rooms will be designed specifically to be conducive to a positive psychedelic experience that might therefore get incremental gains in the outcomes that the patients are going to receive.

“This is what is needed to drive the industry forward. We have also got an ambitious scale-up process that will go hand in hand with our partners’ drug development, as they are looking to increase the number of sites and then potentially increase the number of countries as well.”

Best-in-class psychedelic therapy training

Clerkenwell is working with The University of Manchester to design its own study exploring the therapy component of psilocybin depression treatment.

The team aims to build a best-in-class, accredited therapist training programme aligned with regulation, working closely with Dr Sara Tai, a senior lecturer in clinical psychology at the University of Manchester. Dr Tai, who previously helped design the therapist training programme for COMPASS Pathways, focuses her research on the similarities and differences between types of therapy. 

“We think there is a real uniqueness to psychedelics – unlike any other drugs really in the history of them, the talking therapy component is so important for the vast majority of these conditions,” said McDonald.

“So, by building expertise in understanding what therapy works, working across a range of different psychedelic compounds and a range of different conditions, we are going to be able to build a real best-in-class, therapist training programme that is closely aligned to what the regulators know and understand, and we will look to get that accredited by a serious body.

“There are still a lot of unknowns around the therapy component of these treatments, so we were looking to do some really interesting bits looking at depression – but specifically drilling into the therapy component and what digital therapeutics could be doing to help support the patient in addition to that.”

Fisher commented: “What we are very conscious of is the data on what types of therapy work and how the different types might benefit different people – interrogating how we can optimise the therapy for patients and optimise technology that sits alongside it to support the sustained efficacy of treatment. 

“I think one of the key things that may come out of some of the other trials that have been conducted is that it might be hugely effective in the short to medium-term, but actually if there is not ongoing support – just as with therapy without psychedelics – actually, depression can creep back in.”

Supporting the development of psychedelic care

Clerkenwell is currently working with Octarine Bio, which is which using yeast fermentation to produce psilocybin from sugar, to design clinical trials. 

“They’ve been working with the biosynthesis of various different compounds, they started with cannabinoids and now are looking to develop psilocybin as their first entity but potentially others down the line as well,” said McDonald. 

“We will provide everything from very early stage clinical advisory services, helping them design the study that they want to run, and then actually operationalising that when our site is ready in quarter two of next year. We are also likely to start engaging the regulators on their behalf in the not too distant future.”

In its partnership with Octarine, Clerkenwell has been epxloring conditions that have very poor treatment options available and identifying indications it believes psilocybin-assisted therapy is going to be beneficial for. 

“Octarine’s development is going to be more viable than the traditional lab development models, and also, when done at scale, is going to be considerably cheaper than others out there as well so, we are really hoping that helps with patient access – identifying a niche condition that has very poor treatment options and then providing a drug and this is associated therapy at a reasonable cost.

“When you start looking at the impact on quality of life or whether people are able to return to work and therefore get back into paying taxes, all of those downstream impacts are what we think is really interesting. Looking at some of those early-stage results where people are coming out after a single or two doses are at three months or potentially even six months are essentially symptom-free or heavily-reduced is where we think that there is real value.”

Fisher added: “The whole point of what we are trying to do is help companies that are want to bring these drugs to markets, build the data that is required to present to regulators, and do so in as an efficient and timely way as possible – being very conscious that either the current options either don’t have the correct facilities to be able to generate the best data. 

“Ultimately that will be the way that these drugs can get into patients hands as quickly as possible.

“I think something that Europe, but also the UK especially, has to their benefit here is that it has really strong research. Imperial College London and King’s College are world leaders in psychedelic research – since the start of the psychedelic renaissance. 

“That gives us a really strong basis on which to build collaborative research – there is a rich ecosystem of researchers that are keen to work with different people, and organisations that are just looking to push the whole sector forwards.

“We’re hoping to fit into that, where we can both work with the for-profit in the space and partner with other organisations and researchers, helping to deliver the trials that require input from different areas.”

Fisher, who started working in psychedelic research in 2015 at the Beckley Foundation, drug policy think tank, Volteface, The Loop, campaigning for drug reform, before founding Hanway Associates a cannabis sector advisory firm, continued: “It’s just wonderful to come full circle from where I started. I had a real passion for the potential of psychedelics years ago when it was only in the academic sphere. It didn’t look like this was anywhere near on the horizon. Now, it is very much reality. 

“It will be a paradigm shift when these drugs can actually be delivered to patients and it is very rewarding to be a part of that process.

“We are trying to focus on providing real gold standard, and paradigm-shifting care that we need to be doing in the trials to start with and then hoping that translates into real-world delivery. We are trying to help patients and get to the root cause, with the use of psychedelics in combination with therapy.”

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Markets & Industry

Psychedelic therapy programmes launch to address heartbreak, burnout and more



Psychedelic therapy programmes launch to address heartbreak, burnout and more

Mindbloom has launched its new Mastermind Series of psychedelic programmes for overcoming heartbreak, burnout and other unique mental health challenges. 

Led by and developed with leading experts in the field, each programme combines specialised teachings with ketamine therapy.

All programmes will include six ketamine therapy sessions focusing on a specific mental health issue, expert-led audio, video, and written content for preparation, treatment, and integration, practical tools such as meditation, one-on-one coaching and group integration sessions.

See also  Psychedelics for frontline workers, palliative care and eating disorders

The first programme in the Series is ‘Recovering from Rejection and Failure’, led by Dr Guy Winch who is a leading authority on emotional health, and a best-selling author and TED speaker whose talks have received over 30 million views.

Winch’s programme focuses on healing and preventing emotional injuries that people suffer in their personal, professional and romantic lives.

Mindbloom CEO and Founder Dylan Beynon stated: “More than 100 studies and 20 plus years of clinical use show that ketamine therapy may be the most transformational mental health treatment available today.

“In the face of epidemics of mental illness, addiction, and loneliness, we’re thrilled to offer our clients access to top experts across a range of issues – and to pair their expertise with our best-in-class ketamine therapy honed over hundreds of thousands of treatment sessions.”

“Emotional wounds like rejection and failure can be even more devastating than physical wounds, yet we don’t give them the same time and attention,” added Dr Winch.

“I’m thrilled to combine my techniques for emotional first aid with ketamine therapy, which has been shown to increase neuroplasticity and help build emotional resilience.”

Additional Mastermind programmes will be released in the coming months, including: Getting Unstuck, by Dr Elizabeth Lombardo; Beating Burnout, by Dr Shauna Shapiro; and Coping with Cravings, by Dr Jud Brewer

“Americans are struggling with heartbreak, burnout, and other challenges every day, and they’re looking for new tools to address them,” said Mindbloom’s Medical Director Dr Leonardo Vando.

“I’m grateful to these experts for providing Mindbloom’s clients with the unique practices and insights they’ve cultivated during their distinguished careers, to help them overcome the biggest obstacles in their lives.”

Continue Reading


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.”

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.

Continue Reading

Markets & Industry

Mychedelica launches to revolutionise psychedelic medicine



Mychedelica launches to revolutionise psychedelic medicine

A new company specialising in psychedelic medicine – mychedelica – is offering a comprehensive suite of services to support the advancement of this transformative field. 

With a team of experienced medical writers and research support specialists, mychedelica is committed to providing the highest quality services to researchers, clinicians, and pharmaceutical companies working in the psychedelic medicine space.

Psychedelic medicine is rapidly gaining recognition for its potential to treat a wide range of mental health conditions, including depression, anxiety, addiction, and post-traumatic stress disorder (PTSD). However, the field is still in its early stages of development, and there is a critical need for high-quality medical writing and research support services to facilitate its progress.

CEO of mychedelica, Bilal Bham, commented: “We are thrilled to launch mychedelica and contribute to the advancement of psychedelic medicine.

“Our team of experienced professionals is dedicated to providing the highest quality services to researchers, clinicians, and pharmaceutical companies working in this groundbreaking field.”

mychedelica provides a comprehensive range of services, including:

Medical writing: Experienced medical writers will craft clinical trial protocols, regulatory submissions, and peer-reviewed publications, ensuring that research findings are communicated clearly and effectively.

Funding research support: Experts in grant writing and fundraising strategies will assist researchers in securing funding for their psychedelic medicine studies.

Regulatory consulting: mychedelica’s team of regulatory experts will navigate the complex regulatory landscape surrounding psychedelic medicine, ensuring that clinical trials and products comply with all applicable laws and regulations.

With its commitment to quality and innovation, mychedelica is poised to play a pivotal role in shaping the future of psychedelic medicine. The company’s services will empower researchers to conduct rigorous clinical trials, clinicians to provide effective treatments, and pharmaceutical companies to develop safe and effective psychedelic medicines.

Continue Reading