Psychedelic medicines are entering the latter stages of drug development, progressing from Phase II to Phase III trials, with the sector anticipating their approval and arranging for their adoption.
For drug developers this means focussing on commercialisation strategies, identifying the treatment’s expected patient journey and market size, and collaborating with regulators, healthcare providers and payees to maximise treatment accessibility.
They will also need to mitigate potential bottlenecks and create services that promote the therapy’s integration into existing healthcare frameworks. As the industry approaches significant milestones in the adoption of psychedelic healthcare, PSYCH spoke with decision makers from across the ecosystem.
The Adoption of Psychedelic Medicine
MAPS intends to submit its Investigational New Drug Application for MDMA-assisted therapy in the second half of 2023. This means the company could be generating revenue from the novel therapy for PTSD by 2024, with MAPS aiming to train 25,000 therapists to administer MDMA by the end of the decade.
Speaking at the sold-out PSYCH Symposium on the roll-out of MDMA-assisted therapy, MAPS’ Founder Rick Doblin said: ‘I think we have a very good chance of getting 100% insurance coverage, with copays, for MDMA-assisted therapy in the US. On the National Health Service, I think coverage will also be able to be obtained, but at a lower price.
‘There is an advantage with working with national healthcare providers in the sense that they tend to look at an overall situation. So, not only do they look at the cost of treating the disease, but they also look at related costs such as disability payments for those unable to work.
‘In Europe, even though these costs come from different buckets they are both government buckets. With that in mind, I think we will be able to make a very good argument for cost-effectiveness and national healthcare coverage.’
This sentiment was echoed by Awakn Life Sciences’ Head of Psychedelic Medicine, Dr Ben Sessa, who spoke with PSYCH for The Psychedelics as Medicine Report: Fourth Edition.
Dr Sessa declared, ‘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.’
Drug development programmes typically cost hundreds of millions of dollars to complete. The costs of these programmes escalate the further they progress, with later-stage trials larger and consequently more expensive. In the race to secure market approval, many will have to obtain additional funding or risk going bust.
Rising inflation and a looming recession have made it difficult for drug developers to attract capital, with macroeconomic factors accelerating the market’s maturity and initiating an industry shakeout. With mergers and acquisitions defining the next phase of the industry’s evolution, attention is increasingly turning to early-stage investment opportunities.
‘Psychedelic medicine has reached a critical inflection point in its development,’ recognised Vadim Uzberg, Partner at Negev Capital. ‘The science supports transdiagnostic efficacy in psychiatric conditions; next-generation molecules offer improvements in delivery, safety, efficacy, and scalability; valuations have dropped to more reasonable levels; and big pharma is getting more comfortable with this sector. We expect positive clinical trials results in 2023, and likely some industry consolidation. Overall, we remain excited and optimistic.’
Negev Capital invests in companies conducting preclinical and Phase I studies, with the aim of supporting drug developers to generate intellectual property. To discuss market consolidation, and the investment fund’s focus on early-stage drug development, Uzberg will participate in a fireside interview at Emerging Innovations in Psychedelic Healthcare.
Emerging Innovations in Psychedelic Healthcare
On Thursday, 17 November, 50 industry decision makers will accelerate innovation in psychedelic healthcare through facilitated networking opportunities. Cybin’s CEO, Doug Drysdale, will share insight on the future of psychedelic healthcare at the event and spoke with PSYCH ahead of the occasion.
‘Accessibility is really the core of everything we’re trying to do,’ explained Drysdale. ‘There is room to continue to improve and optimise the treatment as we get closer to market, to minimise the burden on the healthcare system, and make these treatments as accessible as possible.
‘When I look at what is happening across the biotech space, it is all macro driven… In these uncertain times people cycle out of more speculative stocks, like psychedelics, but this creates an opportunity. Fundamentally, nothing has changed about the sector or about Cybin.’
Emerging Innovations in Psychedelic Healthcare coincides with the release of The Psychedelics as Medicine Report: Fourth Edition, the industry’s leading data and insights publication. To register your interest to attend the invite-only event, please visit the website or contact firstname.lastname@example.org.