Psychiatrist Dr Ben Sessa, Head of Psychedelic Medicine at Awakn Life Sciences, specialises in addiction services and psychedelic-assisted therapy.
PSYCH spoke with Dr Sessa regarding Awakn’s business model, therapist training and the potential of psychedelic healthcare on the NHS.
‘At Awakn we have two things we do ,’ explained Dr Sessa. ‘Research and Development and commercialisation.
‘From an R&D perspective, the goal is to repurpose drugs to treat Alcohol Use Disorder, AUD, in combination with our proprietary therapy. On that front we have a completed Phase IIb study using ketamine-assisted therapy for the treatment of AUD and are progressing into Phase III trials very soon. We have just received approval of a grant from the UK government to cover 66% of the costs of the Phase III trial, which is a fascinating development.
‘We will also be delivering the trial within the NHS infrastructure, which really shows the NHS’s intent to try and adopt the treatment. The reason they are both such great supporters of the research is because of its efficacy.
‘The trial resulted in patients experiencing on average 86% abstinence at six months post treatment versus 2% before the trial, which means that study participants went from being sober on average seven days a year to being sober on average 314 days a year. That is approximately a three and a half times greater success rate than the standard care, which is incredible.
‘We have also completed a Phase IIa trial with MDMA-assisted therapy for AUD and are assessing our options on how best to progress this.
‘In R&D we also have some early stage clinical studies into behavioral addictions and gambling disorder in particular, which is investigating ketamine as a treatment. Finally, we have a New Chemical Entity programme – which looks at new compounds to treat addiction.’
Awakn has developed an MDMA derivative with the potential for a quicker onset, which could promote better integration into existing healthcare frameworks. PSYCH asked Dr Sessa about the new chemical entity.
‘We’d like to aim for a two-hour experience,’ declared Dr Sessa. ‘One of the many ways ketamine is very useful is that it is short acting when we give it by intramuscular injection. You are kind of up and down within 90 minutes and that makes it very clinically deliverable because you can do a session in the morning and a session in the afternoon.
‘With MDMA we’ve done research and it is an eight-hour session. It is arguable that you need an eight-hour session, but it’s worth experimenting as to whether we could produce a shorter-acting MDMA-like analogue that would be more clinically deliverable, economical and therefore potentially more attractive to providers like the NHS.’
MDMA-assisted therapy for PTSD is expected to be regulated in Europe by 2024. MAPS hopes to train 25,000 practitioners to deliver the treatment by the end of the decade.
PSYCH asked Dr Sessa if the number of trained therapists could cause a bottleneck in the roll-out of psychedelic healthcare.
‘It is certainly a concern,’ contemplated Dr Sessa. ‘Which is why MAPS is on a very rigorous therapist training programme at the moment. It has been very difficult to train as a psychedelic therapist as you could only really train psychedelic therapists if you had a psychedelic study to carry out.
‘There are only several dozen studies going on around the world. I’m a trained psilocybin therapist because I trained with COMPASS Pathways and an approved MDMA therapist because I trained with MAPS.
‘In the UK the only people trained to use psilocybin or MDMA are the few lucky people who have done similar studies. So, that does indeed induce a bottleneck the minute the drug gets licensed, when there are only a select number of licensed therapists.
‘However, there is not much point in training thousands of MDMA and psilocybin therapists in the UK today as they cannot use it. It will all be about timing over the next few years and getting people trained ready. That way, the minute the drug is licensed, they can hit the ground running.
‘It is a very strange situation in that we are expecting the floodgates to open when MDMA gets licensed. We need to train therapists, but at the moment there is nowhere to train unless taking part in a research study.’
There are long waiting lists for cognitive behavioural therapy on the NHS. With ketamine-assisted therapy proven effective in clinical trials, PSYCH asked about the treatment’s integration into public healthcare.
‘At conferences, people will ask, “Why does Awakn have to be private?” “Why isn’t ketamine-assisted psychotherapy available on the NHS?” Don’t ask me; there is nothing we want more than Awakn’s protocols on the NHS. We would have queues around the block if we could provide treatments to NHS patients.
‘The NHS is a slow beast. It takes a long time to decide what to fund, so it is normal that innovative treatments are available privately first. I have no doubt that in the future psychedelic medicine will be available for free on the NHS for a few reasons – it is safe, it’s effective and it is cheap.
‘It may sound expensive, when a patient has to pay £6,000 themselves. But, as I often say in my talks, there is nothing more expensive than an untreated psychiatric patient.
‘Psychiatric patients who don’t get better don’t work and are often on disability benefits. If we can deliver an eight-week course of ketamine-assisted psychotherapy for £6,000 and the patient gets better and gets back to work, then that is very cheap.
‘As an addiction consultant, I’ve lost count of the number of times I’ve put patients into expensive six-month alcohol rehabilitation programmes costing £50,000 and on the last day they walk out straight into the pub. The current treatments for addictions on the NHS are very poor with poor outcomes and are, consequently, very expensive.
‘£6,000 may sound expensive, but it actually makes total economic sense. I’m quite convinced that the NHS will put these medicines into public healthcare because psychedelic-assisted therapies make sense economically. That is why they are such great supporters of the work we are doing and will play such a critical role in our Phase III studies.’