#CPHI22: ‘Expert warns psychedelic approvals alone not a panacea for patients’
Speaking last week at CPHI Frankfurt, Dr. David Erritzoe – Clinical Senior Lecturer and Consultant Psychiatrist, Department of Psychiatry at Imperial College – called on the pharma industry to work more closely with academia to help bring in new psychedelic therapies. In his keynote address Erritzoe provided an overview of current late phase trials (phase ii and iii), which was especially timely as Compass Pathways announced positives results for its phase iib study on Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression.
In fact, more than 70% of the industry now expects an approval of Psychedelic-therapy combinations inside the next three years according to the CPHI Annual Report. Yet Erritzoe argued we are only at the beginning of this journey and these drugs, especially newer synthetic versions, will have a far wider potential than we have yet studied. He explained that ‘the more profound the condition, the better the therapeutic outcome’. And, although the drug cleared a patient’s system in a day the therapeutic effect had a much longer duration. This means that psychedelics are different to any other forms of treatment, and pose a number of interesting questions for pharma companies looking to move in.
In a bold prediction Erritzoe was much more bullish in his outlook stating that MDMA would be approved for use in PTSD in just a year or 18-months and that psilocybin will follow a year later, provided the data holds in the larger scale trials.
Looking further ahead, the most common prediction (39%) in the CPHI Annual Survey was 3-10 new therapies within the 10-years. However, Erritzoe – who works on a number high profile clinical studies in the UK – believes the industry is again being far too conservative, stating that this is likely be an underestimation of the true potential: “Looking at the pipeline, five approvals in the ten-year timeframe seems very achievable and, I think if all goes well, we will see more than five. Again, my message here is that the approvals are only one part of a complex story and there is lots of promise outside of the current – often narrow – trial endpoints. As we get approvals, and the use of drug/therapy combinations matures we are likely to see even better outcomes and more innovative combinations and better personalisation of therapies.”
One of the unusual aspects of this research field is that many companies and organisations are working on similar compounds and treatment models, so researchers are getting the benefit of shared learnings. However, this also makes the space confusing for companies and investors, in particular because of the challenges arising from the unprecedented pursuit of the same, often pre-existing, molecules from different sides in parallel.
Erritzoe forewarned that one administration of a drug/therapy combination is unlikely to be a panacea for most patients and, how this fits into our established pharma healthcare networks, are valid questions that still need addressing. He added, “we need to take a multi-disciplinary approach to maximise the societal and patient benefit. So, for pharma companies, regulators and payors this requires a slightly different approach in how we research, approve and evaluate effectiveness than we are used to. Standard approval pathways were simply not designed for these types of therapies, and we need greater collaboration to break this new ground together.”
The other factor identified was that more funding of research into mode of action was needed – so that more benefit can be unlocked – and/or the funding of these therapies post approval needs addressing. ‘It would be a shame to have approved, amazingly efficacious therapies that only a few can access.’ added Erritzoe.
The industry should therefore embrace some of the academic findings earlier in future trial designs. For example, group therapy sessions – that are not currently looked at in trials – have the potential to really bring down costs and improve access. ‘Similarly, looking at support groups post-approval, like you see in other areas of mental health, could help ensure long term benefits and crucially reduce the burden on health services’.