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As psychedelic medicines progress through clinical trials, attention is increasingly turning to the commercialisation and adoption of psychedelic healthcare. For drug developers this involves identifying the treatment’s expected patient journey and collaborating with regulators, healthcare providers and payees to promote accessibility.
As we look ahead to 2023, below is a summary of the six best-read articles from The Psychedelics Newsletter in 2022.
At the start of the year, PSYCH spoke with Cybin’s CEO Doug Drysdale on the roll-out of psychedelic medicine and market performance. The company had recently released clinical trial data from studies with its proprietary psilocybin derivative, CYB003, which demonstrated a reduced onset time and 50% reduction in variability compared with psilocybin.
‘Accessibility is really the core of everything we’re trying to do,’ explained Drysdale. ‘Part of the challenge in converting these classical psychedelic molecules into prescribable therapeutics is to overcome some of those limitations that impact accessibility.
‘Psilocybin is very long-acting…To take up a whole room for a whole day with a single patient is inefficient and probably not practical. This resource requirement limits accessibility for patients, so we’ve managed to increase the speed of onset by two times and cut duration in half.
‘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.’
On the subject of market performance, Drysdale cited the widespread impact of ongoing socioeconomic and political turmoil.
‘When I look at what is happening across the biotech space, it is all macro driven. There seems to be a lot of economic uncertainty between COVID-19, interest rates and inflation. There is now political uncertainty in Ukraine and the biotech index is down 30%.
‘This says to me that 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.’
Drug developers such as Cybin are working closely with regulators to accelerate the approval of psychedelic medicine to treat underserved patient populations. Governing bodies have created pathways to expedite the development and review of drugs that may provide a substantial improvement in treatment outcomes.
The FDA’s process is Breakthrough Therapy designation and in the UK the MHRA has established the Innovative Licensing and Access Pathway (ILAP). In October, PSYCH sat down with Dr Laura Squire, Chief Healthcare Quality and Access Officer at MHRA, to discuss ILAP for The Psychedelics as Medicine Report: Fourth Edition.
‘This is an age of change, and we see ourselves as a collaborative and enabling regulator that looks for opportunities to support innovative new products and ways of working,’ declared Squire.
‘The ILAP combines the MHRA’s globally recognised high standards of quality and safety with improved flexibility to reduce the time it takes innovative treatments to be available to NHS patients. The “Innovation Passport”, a new medicine designation, acts as the gateway to entry into this pathway and is awarded to innovative products submitted to the ILAP.
‘The ILAP covers the entire development programme with a clear ambition to speed up the time to patient access. Companies are encouraged to engage early before they have clinical data in order that all the benefits of enhanced interactions with the MHRA and the partners can take place. The ILAP covers the whole life cycle of products, supporting clinical trial recruitment, adaptive inspections, and the collection of real-world data.
‘A successful Innovation Passport designation then triggers the MHRA and partners to create the Target Development Profile document. This living document will set out a unique product-specific roadmap towards patient access in the UK healthcare system.’
MDMA-assisted therapy and psilocybin therapy are anticipated to be regulated in 2024 and 2025 respectively. Assuming similar timelines for other treatments with Innovation Passports, there could be three psychedelic compounds approved for use in the UK by the end of the decade – MDMA, psilocybin and DMT.
To coincide with the launch of the fourth edition of The Psychedelics as Medicine Report, decision makers from across the ecosystem converged to evaluate milestones in the adoption of psychedelic medicine at Emerging Innovations in Healthcare.
The invite-only event on 17 November, hosted by PSYCH at Sea Containers in London, featured a panel discussion on ketamine, MDMA and psilocybin market sizing, in addition to a fireside interview with Vadim Uzberg, Partner at Negev Capital, on market consolidation and market sentiment in 2023.
‘We expect the same market sentiment, which is tough, but we will look to de-risk our investments,’ said Uzberg. ‘Private equity alone is not enough. We need to be creative to finance drug development.
‘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.’
Since Psych Capital’s IPO in June 2022, the publicly listed incubation and pre-seed investment firm has been reviewing Europe’s regulatory landscape and investment opportunities.
As part of this process, Psych Capital has worked closely with the Conservative Drug Policy Reform Group (CDPRG), and in October announced the appointment of Chairman Crispin Blunt MP to its Medical Psychedelic Technical Advisory Board.
On the appointment, William Potts, Chief Investment Officer at Psych Capital, said: ‘Ahead of our next phase, we are delighted to add the CDPRG representative Crispin Blunt, a pioneering and leading healthcare politician leading the UK psychedelic health group, to our Psychedelic Medicines Technical Advisory Board, to augment our regulatory expertise, and to give us a seat at the table in shaping government policy.’
Psych Capital intends to be an active participant in establishing a route-to-market for psychedelic medicines, to revolutionise the treatment of mental health conditions. According to the NHS, 8.3 million people received a prescription for antidepressants in the last year. As they only work for roughly 50% of patients, more effective treatments are desperately needed.
On the subject, Blunt told PSYCH, ‘Depression is the greatest contributing factor to suicide, a cause of disability and it costs the UK £10 billion annually according to research from the Faculty of Public Health. Employment costs associated with mental ill-health cost the UK £94 billion per annum.’
On 29 November, PSYCH released the fourth edition of The Psychedelics as Medicine Report. The report, expanded to include data on adult-use frameworks, contains market valuations and revealed the industry is expected to exceed US$3 billion by 2026.
The industry-leading publication provides a holistic overview of the psychedelic medicines poised for market approval and a balanced perspective of the related socioeconomic opportunities.
The comprehensive account of the industry contains market projections for ketamine-, MDMA- and psilocybin-assisted therapies, with significant inflection points expected in the next three years.
The report revealed ketamine-assisted therapy will account for the majority of the market until 2027 – with revenue from ketamine treatments expected to exceed US$230 million in 2023.
MAPS’ MDMA-assisted therapy for PTSD is the only psychedelic therapy in Phase III clinical trials, with regulatory approval expected in 2024. In North America, the treatment is expected to cost approximately US$7,500 – with patients undertaking two courses of therapy a year. Assuming the price of MDMA-assisted therapy stays consistent, the report estimates the market for MDMA-assisted therapy could exceed US$1.5 billion by 2028.
MAPS’ Founder Rick Doblin commented: ‘There is a big change that’s happened with the rise of for-profit companies. The fact that PSYCH and PSYCH industry reports exist is very exciting.’
In 2021, UK-based COMPASS Pathways shared data from its Phase II trial to combat treatment-resistant depression with psilocybin therapy. If similar results can be replicated in Phase III studies, the treatment could be available to patients in 2025. The report forecasts that if sufficient therapists are trained to administer the psychedelic medicine, the value of the North American market could reach US$1.3 billion by 2028.
Last month, PSYCH spoke with COMPASS Pathways’ CEO, Kabir Nath, to discuss the organisation’s commercialisation strategy.
‘The principal focus of our work has been on North America, although we are looking at Europe as well,’ explained Nath. ‘At COMPASS we are not going to be making investments in treatment centres or hiring therapists; instead, our revenues will come from the drug side. Practically speaking, we are ensuring that our investment goes towards our core strength, drug development.
‘It is important to build out commercial capabilities, but in the next couple of years the strategy will be focused on building relationships, not commercial infrastructure… It is going to be a challenging market environment for the foreseeable future. We have a very strong and experienced management team focused on our priorities and what we need to do.’
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