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Company of the Month: Clerkenwell Health

Finding a ‘niche’ is often offered as a well-meaning but easier-said-than-done piece of business advice. Well, Clerkenwell Health have not only found their niche, but taken it from desk-side project, to being on the cusp of opening a clinic off Harley Street in just a year. We spoke to Co-Founder and Chief Scientific Officer, Henry Fisher, about building a contract research organisation (CRO) specialising in psychedelic therapeutics, including the challenges and ethical considerations at play.

Responding to industry trends

Henry’s DPhil in Pharmaceutical Chemistry is where he developed an interest in the potential for psychedelic drugs being used as part of mental health therapies. It was while working with another company he co-founded – providing business strategy consultancy in the cannabis industry – that he and colleagues noticed a marked increase in commercial interest in the area of psychedelic-assisted therapies. With their prior knowledge, they knew they could have an impact, and began considering where they could be useful:

“What we realised was that there was a real gap – and a real need – for a specialist CRO service to design and deliver specialised clinical trials for psychedelics and psychedelic-assisted psychotherapy. The only alternatives that companies had were to work with mainstream CROs that didn’t really understand the space – and some of the considerations that are unique to psychedelics – or to work with universities, who don’t necessarily have the bandwidth, capacity or ability to align their timelines with drug development.”

And so, Henry and the two other co-founders, Tom McDonald (CEO) and Sam Lewis (CFO) had found their niche. What began as a side-project for them all during Covid-19 lockdowns, became a full-time commitment in early 2021 and, since then, has flourished into a growing business, currently with a team of 15 employees.

Challenges of working with psychedelics

Typically being developed to treat severe depression, anxiety and post-traumatic stress disorder (PTSD), psychedelic-assisted therapy involves the ingestion of a psychedelic, followed immediately afterwards by a therapy session with a specialised therapist.

As Henry expands on the unique challenges of working with psychedelics, the benefits of working with specialists for companies in this space become very clear. In particular, the challenges for clinical trials around blinding and expectancy require careful consideration.

Blinding – to ensure that neither the patient, nor the therapist working with them, knows whether they have been given the trial drug or a placebo – has vastly different considerations, versus most other clinical trials. After all, you would expect most people to become aware of the effects of a psychoactive drug:

“There are very particular strategies around how you talk to patients and describe what they may, or may not be feeling, that are very important to design rigorous clinical trials in this area. There are also interesting tactics that can involve whether an inactive or an active placebo is used. An active placebo might be something that stimulates another altered state of consciousness that, for someone that hadn’t experienced psychedelics before, could be mistaken for the type of drug being trialled.”

This specialist knowledge, coupled with understanding of managing the raised expectations of trial patients – chiefly caused by increased press attention in the area over the last few years – is where Clerkenwell Health feel they can really add value to the clinical trial design process.

Opening a trial site

In addition to supporting the design process, the team are also on the cusp of opening their first research site – a specialist centre for conducting clinical trials in psychedelic therapies.

One of the key aspects in the theory behind psychedelic-assisted therapy is that psychedelics can induce a neuro-plasticity. This can then be used to augment a psychotherapeutic intervention (or talking therapy), typically targeted at changing a patient’s perspective or enhancing coping skills. The setting the process happens in is clearly important. This brings us to the carefully-made decision to choose central London, just off Harley Street, for their first site:

“It was really important to us to have a site that was aesthetically pleasing and didn’t feel highly clinical, so being attached to a hospital, for instance, wasn’t an option. The site we found really fits the bill in that regard, and we’ve designed it to really facilitate a high quality therapeutic experience. In addition to the aesthetics, the access and transport links are second-to-none. One of the challenges every CRO faces is recruitment. Being situated in central London gives us access to a huge pool of people within easy travelling distance.”

Tom sought support from MedCity while scouting for the site and added:

“It has been great working with MedCity both in terms of support identifying potential sites for our research facilities, as well as a series of useful introductions to relevant healthcare operators able to help accelerate our growth.”

Funding growth

Clearly, investment in a central London site and growth at this speed doesn’t come without monetary investment. But investors appear to have been attracted to the company’s specialist offering, judging by their current seed funding round. Investors to date include mental health-focused venture capital firms Lionheart Ventures and Vine Ventures.

As well as investors’ input, being in a position to quickly earn revenue has been a key factor in the company’s growth. Henry believes this is down to their niche specialism, which has allowed them to quickly add value to the clinical trial design process for smaller startups working in this space. These have included Psyence Group, which is looking into treatment of adjustment disorders in patients with a terminal cancer diagnosis, and Mindset Pharma, who are developing next generation psychedelic compounds, specifically for the treatment of neurological and psychiatric disorders.

Ambitious future plans

In addition to the immediate plans to open their central London clinic and begin delivering clinical trials, the team have longer-term plans to open up further sites that offer a variety of settings, initially in the South East of England, but, longer term, in and around a number of hubs for this kind of research in Europe. Copenhagen, Switzerland and Barcelona are key targets on that list.

Alongside the ability to build capacity in delivering clinical trials, Henry also hopes this will allow them to contribute to building on the body of research into this area.

“There’s lots to find out about how these therapies can be made more efficient, while still delivering benefit to patients. That might be more remote engagement or augmentation with technology, for example. We think there’s real opportunity for us to innovate in these areas, as well as in gaining a detailed understanding of how settings affect different subsets of patients.”

Henry is also keen that they are ambitious about their ability to help set ethical standards for this relatively nascent field:

“Because of the history of the legalities around psychedelics, there has been, in the past, something of an underground industry for psychedelic-assisted therapies. This meant that some unusual practices developed, and, as interest in research grew, there wasn’t the regulatory oversight there should have been.”

Henry feels that regulators and companies alike are becoming more aware of their responsibilities now, but Clerkenwell Health also see themselves as being in a powerful position to help lead the field and hold sponsors to higher levels of ethical standards:

“Just one example that we’ve taken a stance on as a company, is in post-trial support for patients. This is yet another challenging part of this kind of intervention, because it might not be appropriate to simply hand a patient back to mainstream mental health care afterwards. We see it as our responsibility to ensure patients receive the follow-up care they need though, so it’s something we put a strong emphasis on.”

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