Many psychological and neurological disorders are inadequately addressed by existing drugs. Treatment resistance affects around 20-60% of patients with a psychiatric disorder, and 33% of those suffering from a neurological condition, such as epilepsy. Drug resistance can have a profound detrimental effect on patients and their families, leaving them with no option but to seek alternative treatments.
Recently, psychedelic drugs have been at the forefront of therapeutic innovation, showing promising results in treating a range of conditions. With that, this article explores recent advancements in the mainstreaming of psychedelic-assisted therapy, with an industry spotlight on synthetic biology platform, Octarine Bio.
The Mainstreaming of Psychedelics to Date
The psychedelic therapeutic space has made significant progress in recent years. Laws are increasingly being relaxed, clinics are beginning to be set up and more and more research is being conducted. All of this shows great promise for the ‘psychedelic renaissance’.
September 2022 saw clinical research organisation, Clerkenwell Health, open Europe’s first commercial psychedelic research facility in London, to allow drug developers to pursue clinical trials from phase I all the way up to phase III. The first trials are set to begin this month, with Clerkenwell’s client, Psyence, exploring the efficacy and safety of using psilocybin-assisted psychotherapy, compared to psychotherapy alone, to treat adjustment disorder in patients with an incurable cancer diagnosis in a palliative care context, following phase II approval from the MHRA.
Clerkenwell Health have also launched a first-of-its-kind training programme for therapists interested in working with psychedelic drugs. The free programme is designed to grow the workforce and remove barriers to the industry, addressing the lack of therapists identified as a hindrance to the development of the sector, as well as breaking down stigma within the field.
Another important name in the mainstreaming of psychedelics in the UK is Awakn Life Sciences; a biotechnology company focusing on researching, developing and commercialising therapeutics. They currently operate two clinics in the UK, in Bristol and London, using ketamine-assisted therapy to address addiction, anxiety disorders, PTSD, depression and eating disorders.
Recently, Awakn have become the first company to receive government funding for a phase III psychedelic trial, showing the mainstream interest in the use of psychedelic therapeutics. The study follows on from their phase II a/b trial which explored the efficacy of ketamine-assisted therapy in treating Alcohol Use Disorder, and reported an average of 86% abstinence at six months post-treatment compared to 2% pre-trial.
Scientific advancements aside, psychedelic-assisted therapy has also enjoyed increased visibility within popular media. Based on Michael Pollan’s book of the same name, the Netflix series ‘How to Change Your Mind’ has invited audiences to reflect on the ways they view psychedelic substances by examining their use within the therapy context.
For the most part, the series has been well received by viewers, with many now reconsidering their outlook on psychedelic-assisted therapy. There is no doubt that this breakthrough into popular debate will continue to normalise and destigmatise the use of psychedelics to treat mental health conditions.
But, there is still more to be done…
Despite these advances in the mainstreaming of psychedelics, there are still, clearly, a number of barriers that need to be addressed.
At present, psychedelics still exist within their own ‘bubble’, resulting in the term ‘psychedelic industry’ and preventing assimilation into the wider biotech and pharmaceutical industry. We have seen the medical cannabis market fall into the same trap, resulting in medical cannabis being pushed to the periphery of prescribing. The psychedelic industry must take notice and act to avoid the same fate.
We spoke to Nethaji Gallage, CEO and Co-Founder of synthetic biology platform Octarine Bio, for a deeper insight into where the industry currently is in its journey to becoming ‘mainstream’: “In my opinion it needs to be mainstream, it cannot be a ‘psychedelic’ industry as this comes with negative backlash. The industry needs to be seen as a pharmaceutical one, bio tech one, fitting into these layers. When you have such a revolutionary technology, you have to pick your battles to fit into the mainstream.”
In the coming years more and more companies will have to consider this process of mainstreaming, or face difficulties when it comes to raising funds.
Moreover, there is a worry within the industry that the thrilling ‘psychedelic renaissance’ has veered away from rationality and into misinformation and overexcitement. Since the labelling of psilocybin as a ‘breakthrough therapy’ by the FDA in 2018, there has been an apparent rush to patent psychedelic compounds, resulting in the narrative that these drugs can ‘cure’ mental health conditions.
There is a clear need for future coverage of psychedelics to tread carefully and for scientists and practitioners to emphasise that the drug is merely a ‘catalyst’ to the therapeutic process, and not a form of therapy in and of itself.
Therefore, it appears this ‘psychedelic renaissance’ has transformed into a ‘psychedelic hype bubble’ that urgently needs to be burst.
A paradigm for the future
In looking to the future of psychedelic therapeutics in the mainstream pharmaceutical industry, Octarine Bio appear to be setting the precedent for other companies to follow.
The emerging synthetic biology company aim to further normalise psychedelic-assisted therapeutics, identifying that many psychological conditions are poorly addressed by current pharmaceuticals. Therefore, they have turned their focus to creating products in critically overlooked areas, opening up a huge opportunity for psychedelic therapeutics.
They hope this will revolutionise both the psychedelic and cannabinoid industries by addressing levels of the supply chain and making compounds more accessible and cost-effective. Impressively, they create psychedelic compounds out of fermenting yeast, much like the beer brewing process. Not only does this make an accessible product, but it is also scalable and more environmentally friendly, therefore allowing the mainstreaming of psychedelics to become a more achievable reality.
There is also clear outside interest in a project of this nature. At the end of September 2022, the company announced that they had raised €2m in funding and attracted a new investor. Therefore, it appears that future expansion and research is on the cards.
Importantly, Octarine Bio represent the key message that the psychedelic industry should be seen as part of the wider biotech/pharmaceutical industry. It is only hoped that other companies follow suit to push boundaries, break stigma and see psychedelics as pharmaceuticals.
This piece was written by Volteface Intern Megan Townsend. Megan is a current MA Criminology student at Birmingham City University. Tweets @megant2799.
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