Analysts have predicted a surge of M&A activity in psychedelic healthcare, following a widespread industry shakeout accelerated by a turbulent economic climate. To discuss the organisation’s clinical trials and investments, PSYCH spoke with Beckley Psytech’s CEO Cosmo Feilding Mellen.
Beckley Psytech recently announced the completion of its Phase I trial, with its intranasal 5-MeO-DMT formulation BPL-003. In the announcement, the company declared that consciousness-altering effects of the drug had subsided for 90 minutes. PSYCH was interested to learn how this translated to in-clinic treatment times.
‘The average duration of the experience was 40 to 60 minutes,’ said Feilding Mellen. ‘Ninety minutes was the absolute maximum and ideally we would target two hours or less in the clinic.
‘Clearly there will be numerous stages to go through in the regulatory process, with Phase II studies in patients and discussions with regulators before we can commit to definitive treatment durations.
‘At this stage, we are very encouraged by data that shows the average treatment time is going to be under an hour – enabling us to aim for an in-clinic time of just two hours.’
Beckley Psytech intends to administer BPL-003 in the treatment of alcohol-use disorder and treatment-resistant depression. In the UK, over two million adults have problems with alcohol abuse, with alcohol-related harm costing the NHS £3.5 billion every year.
The UK government pledged two-thirds of the funding for Awakn’s Phase III study in the treatment of alcohol-use disorder. With this in mind, PSYCH asked whether Beckley Psytech was pursuing the MHRA’s Innovative Licensing and Access Pathway (ILAP) to accelerate the therapy’s time-to-market.
‘The idea behind ILAP is great, but as it is a very new system it still needs to be tested out. We actually have an Innovation Passport for ELE-101, our lead psilocin candidate, and so we are going to assess how much difference it makes before we apply for BPL-003.
‘There is a huge unmet need for alcohol-use disorder and, more broadly, substance-use disorder. We are launching a Phase IIa trial with 5-MeO-DMT as an exploratory study into the treatment of alcohol disorder and if we get compelling data would certainly explore ILAP opportunities with the MHRA and Breakthrough Therapy Designation with the FDA.’
Beckley Psytech is something of an outlier in its study of 5-MeO-DMT, with the majority of drug developers in psychedelic healthcare focussing on psilocybin, MDMA and, to a lesser extent, LSD and DMT. Different tryptamines have distinct onset and offset times, which closely correlate with treatment times and, importantly, treatment costs.
PSYCH asked Feilding Mellen if the differences between psychedelic medicines extended beyond duration of effects.
‘There are certainly key differences but, until more clinical trials are conducted, we cannot state so with absolute certainty.
‘What we know about 5-MeO-DMT compared to other drugs is fairly extensive. There is a huge amount of real-world anecdotal and observational data. By observing how these drugs have been used, it gives us an idea of their safety and potential therapeutic applications. This is important qualitative data that we can caveat with the findings from clinical trials.
‘5-MeO-DMT has been found to induce subjective experiences more reliably than any other known psychedelic compound, and in literature the intensity of subjective experience correlates with positive treatment outcomes.
‘We believe that we can more reliably induce these kinds of therapeutic outcomes with 5-MeO-DMT than other compounds. That is the concept that we are aiming to prove through clinical trials.
‘There are other short-acting psychedelic medicines, such as DMT for instance, which is a very interesting compound in its own right. However, they all induce different qualitative experiences and, from a scientific perspective, they all have different receptor binding profiles.
‘While all tryptamines act on the 5-HT2A receptors, they also act on multiple other serotonergic receptors. This may be one of the driving forces behind the different qualitative experiences and, potentially, the different therapeutic outcomes.
‘Typically, 5-MeO-DMT does not produce visual hallucinations, whereas DMT is known to produce very intense visual hallucinations. This may be a distraction when used in a therapeutic setting; however, these are hypotheses, rather than facts, that need to be further investigated.
‘I believe there is a space for multiple psychedelic compounds in the market and that some patients will be better suited to certain compounds than others. There are lots of examples of therapeutic areas where multiple drugs, with different but similar mechanisms of action, exist side by side.’
Beckley Psytech has a diverse drug development pipeline and is expecting to release data from its Phase I study with psilocin formulation ELE-101 in the first half of 2023. ELE-101 was the lead candidate developed by Eleusis, the company Beckley Psytech acquired in November.
‘We want to develop multiple compounds within this class with different applications,’ explained Feilding Mellen. ‘It increases our chance of success to have multiple shots on goal, so we have spent a long time assessing the opportunities out there.
‘The Eleusis opportunity really stood out from a business development perspective because of the ELE-101 programme. ELE-101 is an intravenous psilocin infusion that alleviates some of the practical limitations of psilocybin.
‘Psilocybin is metabolised into psilocin, with psilocin the active ingredient, but absorption rates can vary significantly, which makes the patient experience hard to predict. Secondly, the duration of experiences with psilocybin can be between six and eight hours, which is a long time for patients to spend in the clinic.
‘There is compelling safety, tolerability and efficacy data for both psilocybin and psilocin, with ELE-101 delivering the right outcomes in a controllable, efficient and practical way. Delivering the drug intravenously massively reduces the amount of variability in terms of absorption rates. It also reduces the amount of drug that needs to be delivered, and the duration of the experience is much shorter.
‘If we are able to deliver psilocin in a way that is fast, controllable and consistent, then that is a significant practical improvement on the oral administration of psilocybin. The development of ELE-101 is essentially a fast-follower strategy to oral psilocybin administration, building off the existing safety and efficacy data of psilocybin and its active metabolite, psilocin.’
Beckley Psytech’s purchase of Eleusis was arguably the most high-profile acquisition in psychedelic healthcare in 2022. PSYCH asked Feilding Mellen if the company intended to continue M&A activity in 2023.
‘We have only just bought Eleusis, so are not going to get carried away. We believe we have a really exciting preclinical and clinical pipeline, with two short-acting patent-protected psychedelic compounds in clinical development. BPL-003, our intranasal 5-MeO-DMT formulation, is moving into Phase II trials, and our intravenous psilocin formulation, ELE-101, is in Phase I.
‘We also have an extensive library of preclinical new chemical entities as well. While we have a strong portfolio, we are not blinkered and are keeping a close eye on what is out there. There are lots of people doing really exciting things, and I think there will be further consolidation in the space over the coming years.’