Will the UK be the first European country to embrace psilocybin-assisted therapy?

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At Prime Minister’s Questions on 19 October, Boris Johnson responded to Tory MP Crispin Blunt’s call to reschedule psilocybin. Johnson told the house that he would consider ‘recent advice on reducing barriers to research with controlled drugs’, in a statement that galvanised the country’s biosciences industry. 

In the UK, psilocybin is currently a Schedule 1 drug under the Misuse of Drugs Act, alongside MDMA and LSD. This strictly prohibits its possession, even in medical settings, with research licences granted by the Home Office few and far between.

Advocates for the psychedelic healthcare industry hope the UK could soon move psilocybin, and other compounds, to Schedule 2 to reflect mounting evidence about their therapeutic potential. This would facilitate greater medical research, laying the foundations for a domestic industry with direct access to London’s capital markets.

In spite of the industry’s fledgling status, the UK is already home to prestigious psychedelic research institutions and world-leading publicly traded companies, with Awakn Life Sciences opening the country’s first psychedelic-assisted therapy clinic earlier this year.

The ABC of the UK’s psychedelic healthcare industry

Awakn Life Sciences (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) currently operates two ketamine-assisted therapy clinics in the UK – in Bristol and London – and one in Norway through the acquisition of Axonklinikken AS

In addition to its clinical operations, Awakn develops psychedelic therapies and treatment protocols to treat addiction disorders. The organisation recently secured exclusive rights to data from Imperial College London’s clinical trials to treat alcoholism with MDMA, which indicates Awakn will expand its portfolio to other psychedelic medicines following their regulatory approval. 

Awakn is currently valued at £23.4m with a market cap of over £28.5m. 

In the summer, Beckley Psytech announced the completion of an oversubscribed Series A funding round – raising £58m. Beckley Psytech was founded in 2019, with expertise developed over 20 years by the Beckley Foundation – the prestigious research institution. 

Speaking to PSYCH, Beckley Psytech CEO Cosmo Feilding-Mellen said: ‘We upsized the funding round to US$80 million and have now raised over US$100 million to date. It helped that we previously had a very successful company that made investors significant returns, but we also attracted new, well-respected institutional investors from healthcare, breakthrough science and psychedelic-focused funds.’

The Oxford-based company has generated investor interest through its links to the Foundation and its ongoing clinical trials with psilocybin and intranasal 5-MeO-DMT. The company expects the read-outs from its clinical studies early next year, which it hopes will validate its proof-of-concept to provide a value inflection point. 

The UK’s highest valued psychedelic company, COMPASS Pathways (NASDAQ: CMPS), is further along in its development of psychedelic medicines than the vast majority, as its synthetic psilocybin formulation COMP360 was granted breakthrough therapy status by the FDA in 2018.

The endorsement of the federal regulator suggests COMPASS may be the first company approved to provide psilocybin-assisted therapy, as and when COMP360 completes the required clinical trials.  As the drug is currently in Phase IIb of the trials, there is a high likelihood it will be approved and available to US patients with treatment-resistant depression.

COMPASS is currently valued at £876.9m with a market cap of £1.09b.

Psilocybin-assisted therapy in the UK

Discussing the possibility of psilocybin being rescheduled in the UK, Johnson said he would get back to Blunt, with the country’s operators and supporters waiting expectantly in the wings. Blunt’s warnings about a failure to reschedule psilocybin were ominous, accusing the Home Office of ‘perpetuating what can be considered the worst research blackout in scientific history’, with ‘dire consequences for the UK’s life sciences sector’.

The Psychedelics as Medicine Report: Third Edition revealed the medical psychedelic market is valued at US$190 million, and is expected to exceed US$2.4 billion by 2026, with substantial rewards for early investors. Although the Home Office is currently reviewing the barriers to research, it has sought to temper industry excitement, declaring that the department ‘currently have no plans to reschedule psilocybin’.

However, as clinical trials continue to demonstrate the efficacy of psychedelic medicines, and as their adoption and accessibility grows around the world, the Home Office may be unable to stem the tide of change. 

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