To strengthen the adoption of psychedelic-assisted therapies, drug developers are striving to minimise their cost – with shorter lasting tryptamines. Psilocybin can induce altered states of consciousness for over ten hours, during which time patients need to be supervised by trained practitioners. DMT and 5-MeO-DMT have much shorter onset and offset times, enabling treatments in under 90 minutes.
This substantially reduces the resources required to provide the novel interventions, facilitating their integration into existing healthcare frameworks. This is particularly true of nationalised healthcare providers, such as the NHS, where price is of paramount importance.
UK-based Small Pharma and Beckley Psytech are conducting clinical trials with DMT and 5-MeO-DMT to treat major depressive disorder and treatment-resistant depression. PSYCH spoke with Beckley Psytech’s Chief Scientific Officer, Stephen Wooding, and Small Pharma’s Chief Medical and Scientific Officer, Carol Routledge, on streamlining psychedelic-assisted therapy.
Beckley Psytech recently initiated a study with King’s College London on the tolerability of its intranasal formulation of 5-MeO-DMT. PSYCH asked Wooding if an intranasal formulation of the drug was developed for its short duration and to decrease treatment times in the real world.
‘5-MeO DMT doesn’t have good oral bioavailability, so the main reason for looking into intranasal delivery was to find a patient-acceptable way of getting around that,’ mulled Wooding. ‘We’re very familiar with what is happening with psilocybin. We’re doing some work with psilocybin ourselves, but the relative burden of being in a facility for a significant period of time, for the room and the people and so on and so forth, may in the end be a sort of a negative in terms of uptake.
‘Our view was if there’s a way of doing this well and effectively, and that’s the key – well and effectively – but quicker, then that’s going to work well for the patients ultimately, but also then for the services that deliver the treatments. So, it’s definitely a driver in the space.
‘If you think about 90 minutes versus 6 or 7 hours, that seems fairly clear-cut, but that’s a very empirical way of looking at it. If it’s 90 minutes and it doesn’t work, then it doesn’t work. If it’s 6 hours but it works really well, then players will look at the overall efficiency, not just at resource utilisation.’
Wooding’s sentiments were echoed by Small Pharma’s Chief Medical and Scientific Officer, Routledge:
‘Imaging studies demonstrate that DMT, even though it produces a short psychedelic experience, has mechanisms that seem to be very similar to psilocybin – which is a demonstrated antidepressant.
‘As the psychedelic experience is very short, between 20 and 30 minutes, even when you add the therapy component the whole treatment is still relatively short, between one and a half to two and a half hours. That is a real benefit to patients, with much less time needed in the clinic and a duration of action that lasts a few months.
‘Therapeutically it should perform at least as well as psilocybin, but, from a patient burden and clinical flexibility standpoint, fitting into a standard treatment regimen, a molecule with a short psychedelic experience would be much more beneficial and the ideal molecule.’
Beckley Psytech’s Wooding worked as a physician in the NHS for seven years before joining Janssen UK to develop expertise in both drug development and delivery systems. In 2011 he was appointed Head of Market Access EMEA and in 2015 became Head of Global Commercial and Market Access Strategy, leading health economics and strategic marketing to provide rapid and sustained access to innovative medicines.
PSYCH asked Wooding if unique challenges were faced in the psychedelic healthcare industry, as opposed to traditional pharmaceuticals.
‘The combination of the drug and psychotherapy is critical. What will be interesting to see is how the healthcare infrastructure reacts to that. That will vary around the world because different healthcare systems are set up differently and mental health generally is not well resourced.
‘I think a lot of the issues people look at, such as a lack of psychotherapists, that all melts away if you’re able to take a severely depressed patient and actually transform their lives. Those patients have a lot of comorbidities, so they are actually quite burdensome on healthcare systems.
‘You might need to have therapists, but if you can demonstrate that you have a patient who has responded well and can get back to doing things that they want to do, then I think that really makes a difference in terms of how you bring these medicines to market.’
With extensive insights into gaining pharmaceutical market access in Europe and the rest of the world, PSYCH asked the former Janssen UK executive how far he believes Europe will be behind North America in the adoption of psychedelic medicines.
‘There is usually a delay into Europe, but it will depend a lot on the efficacy data. If you look at the MDMA PTSD data, it’s pretty impressive. If that can be replicated in a second Phase III trial, then that speeds things through with the regulators.
‘The other piece that is different in Europe is that market access is driven much more by health technology assessments, so bodies like GBA and in Germany, they tend to look at the product within the context of the settings that it’s going to be used and what else is available. That does happen in the US, but to a lesser extent, and certainly happens in Canada, which is more like the European market in that regard.
‘In the sort of socialised medical care markets, where a lot of it is picked up by government and insurance providers linked to government, there is usually a delay, not necessarily so much with registration. Companies tend to go to the US first and then follow into Europe, where you have to negotiate price and reimbursement, as that takes additional time.
‘I think one of the reasons that companies look at the US first is that market access is a little bit easier. So, if you’re pushing against a door, you can actually move forward quickly following your license. In most countries in Europe, you get the license and then you’ve got to persuade people to pay for the drug.
‘The US is getting more complex in that regard and insurers are increasingly looking at these things and asking if they represent real value… I suppose the difference in the US is that innovation tends to be a little bit more embraced. In Europe it’s embraced but somewhat more slowly, with a look at the price and the associated costs.’