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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.

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Developing a gold standard for psychedelic clinical trials in Europe

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.”

Policy

Italian campaign on psychotropic substances has signatures verified

Co-founder and international co-ordinator Associazione Luca Coscioni shares his thoughts on the outlook for the campaign.

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Italian campaign on psychotropic substances has signatures verified

Signatures for an Italian campaign calling for the decriminalisation of psychotropic substance cultivation have now been verified by officials.

In 2021, the campaign gathered the half a million signatures needed to trigger a referendum in less than a week. All of those signatures needed to be verified as Italian citizens in order to progress.

With the signatures now verified, one more step remains until a referendum can be called in the spring.

The campaign has focused on cannabis but pertains to the cultivation of all psychotropic substances, such as mushrooms and peyote. 

It has been spearheaded by Forum Droghe, Meglio Legale, Antigone, Luca Coscioni Associations, Società della Reagione, and is supported by parties Volt Italia, Possible, Italian + Europa, and the Communist Refoundation.

Speaking to Psychedelic Health, Marco Perduca, co-founder and international co-ordinator at Associazione Luca Coscioni, which supports freedom of scientific research, commented: “I think this confirms the good idea we had in August, which was that there’s so much popularity concerning the need to amend the drug laws – in particular concerning cannabis – that the moment in which a lot of people would have been allowed to do something very quickly to support the referendum, they would have done it.

Find out more on what the referendum means for psychedelic research and the Right to Science

“We collected the necessary 500,000 signatures in less than a week and the remaining 30,000 signatures in the additional 10 days. According to the law, it’s not only necessary to submit signatures, you have to document that those who signed are certified registered voters in Italy. 

“This is why it took two and a half months to count. This is the first step.”

The campaign aims to modify the wording of “cultivation” in the Consolidated Law on the Discipline of Narcotic Drugs and Psychotropic Substances in Presidential Decree 309/1990.

“The second step is that a title is offered for the referendum – which, according to our reading, was a little too strict on the words that we were eliminating,” said Perduca. 

“So, we found a compromise solution in which, despite the fact that the word “cannabis” will not appear in the text nor in the title, at least the conduct of cultivation, sharing and personal use are represented in the title.

Find out how UK drug policy is hindering scientific research from the CDPRG’s latest report

“The law is very complicated to amend. You cannot just take away a plant or a substance from the schedule. You have also to find other parts of the law that should be eliminated because what is penalised is the action of the plant, per se. 

“So, according to our reading not only of the law but also of the jurisprudence of previous decisions of the Constitutional Court that have blocked similar referenda proposals in 1997 – we decided to go this way. But at least it is clear that it’s a referendum about cultivation and the personnel use and sharing of so-called “soft drugs”.”

Perduca highlighted that the campaign is now working on a document that will be presented by two lawyers before the Constitutional Court on February 15 together with seven other referenda.

“This document will touch upon issues such as the international implications of the deletion of the parts of the law and the constitutional requirements of Article 75 that prohibits the submission of referendum on issues – changes to the constitution, changes in the fiscal system, but also changes in laws that have enacted international treaties.

“And there could be a doubt here that we are in fact, working to do that. We are not because we are just eliminating some words, so we are not un-ratifying a document.

“The law we are working on has never been considered an implementing instrument of the 1988 Convention on drugs. And the third part is the penal part because of course, taking away criminal sentences we have to give as satisfying arguments that the law after the elimination of the words of the referendum is an immediately applicable law.”

The Constitutional Court has until 10 March 2022 to make its decision public. 

Perduca highlights that Italy is currently in a critical political situation, as, due to a new agreement that on 24 January 2021, the Parliament must elect the new president of the republic.

“If the current head of government is going to be elected president of the Republic, there is going either going to be a reshuffling in government or – and this will pose a huge problem for the referendum – if they won’t sign an agreement there is going to be early elections. 

Find out more about public opinion on psilocybin in the UK

“The referendum will push to 2023 because our law doesn’t allow us to have political elections and referenda at the same time.”

If early elections do not happen – Perduca says the campaign will request a vote on the referendum to take place on the same day of administered municipal elections at the beginning of June. 

“The major obstacle now will be to reach the quorum which is 50 per cent of the population plus one vote. We are talking about 27 to 28 million people beyond the age of 18 to turn out and vote.

“The other important political element to take into consideration is that there’s going to be eight referenda before Constitutional Court on 15 February. 

“As well as this campaign, there will be one euthanasia which is also co-promoted by the Lucas Sione Association, which collected twice as many signatures as this one. So, legalisation of euthanasia is a hugely popular theme, but the other six have been promoted by the parties belonging to the center-right coalition, who are all opposing the other two referendums. So, if there is this synergy between those that will ask their voters to go and vote yes for their six and at the same time vote no to the other two. 

“We are counting on people to show up because we know both euthanasia and cannabis are so hugely popular. There’s absolutely no discussion that we’re going to win if there’s going to be a quorum. And so in the event in which all a referendum we will put to a vote. 

“There is some hope that the turnout will be significant. If the Constitutional Court will say no to either all six or to some of the most politically charged of the six referendum concerning the reform of the administration of justice in Italy, things will turn out in a different way. 

“We are ready to fight our battle.”

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Markets & Industry

Dealers licence for psychedelic medicines received by Psygen Labs

Psygen hits a major milestone with the receipt of a dealer’s licence from Health Canada.

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Dealers licence for psychedelic medicines received by Psygen Labs

Psychedelics manufacturer Psygen has received the dealer’s license for LSD, MDMA, psilocybin, psilocin, DMT, 2C-B and mescaline.

Receipt of the Health Canada dealers licence opens the doors to the commercial production of psychedelics at Psygen’s Good Manufacturing Practices (GMP) facility.

The licence will enable, Psygen Labs, a wholly-owned subsidiary of Psygen, to manufacture, sell, import, export and otherwise deal with the above-listed controlled substances. The company In also manufactures high-potential unscheduled substances such as 5-MeO-DMT, ibogaine and others.

CEO of Psygen, Danny Motyka, commented: “Psygen’s dealer’s licence is a major milestone that opens the doors to commercial production of GMP psilocybin and other psychedelics at our facility. 

“Our dealer’s licence issued following a perfect inspection, meaning we had zero observations from the inspector, which is indicative of the diligence and skill that Psygen brings to our work.”

The licence will enable a global reach for Psygen’s facility, which is Canada’s only dedicated manufacturer of synthetic psychedelics based in Calgary, Alberta. Upon completion of the facility Psygen will begin onsite manufacturing of synthetic psychedelics for use in clinical and scientific research.

CSO, Peter van der Heyden, commented: “A primary application for psychedelics is to support psychotherapy for treatment of mental health conditions. 

“After two years of a global pandemic, mental health conditions are a more urgent need than ever. We are excited to supply material for use in clinical trials and the SAP to further validate the utility of psychedelic medicines.”

The company has also announced it will be providing GMP psilocybin for use in patients through Canada’s Special Access Program, following recent amendments that were made to allow access to restricted drugs such as psilocybin and MDMA through the SAP.

See also  Canada's amendment allowing patients access to psychedelics welcomed

GMP psilocybin previously manufactured by Psygen personnel in collaboration with a licensed dealer using Psygen’s methods has already been used in clinical trials for development of therapeutic products. 

The company also has over twenty supply agreements in place for psilocybin, DMT, ibogaine, 5-MeO-DMT, MDMA and LSD to be fulfilled globally.

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Markets & Industry

Numinus wellness now trading on the Toronto Stock Exchange

The mental healthcare company has graduated from the TSXV.

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Numinus wellness now trading on the Toronto Stock Exchange

Numinus Wellness received final approval from the Toronto Stock Exchange to graduate its listing to the TSX from the TSX-Venture Exchange.

Numinus Wellness‘ common shares began trading on the TSX under the symbol NUMI on December 16, 2021, and rang the opening bell to celebrate the milestone.

Numinus Founder and CEO, Payton Nyquvest, who was joined by members of Numinus’ senior management team at the event, spoke to Psychedelic Health to say: “I’m proud of what Numinus has achieved over the past three years by staying true to our mission of providing accessible and innovative care and focusing on being in service to all in need. 

See also  Extension of MDMA PTSD study to be hosted by Numinus

“Graduating to the TSX is an important milestone for Numinus as we take key steps to heighten our corporate profile and reach a broader range of investors. 

“This up-listing is another indication that Numinus has effectively advanced our healthcare strategy, met our business objectives, and built a rapidly scalable growth platform to lead the emerging sector of psychedelic-assisted psychotherapy. 

“This is also reflective of many exciting developments occurring at Numinus. We’re actively growing our clinic network across North America, expanding our lab capabilities, and strategically investing in clinical research to drive long-term value creation for our investors. 

“This is only the beginning of our journey, and we look forward to continuing to champion our mission in this industry.”

The company will be trading on the TSX under the symbols NUMI.WT, NUMI.WT.B and NUMI.WT.C.

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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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