Novamind today announced it has been contracted by the Usona Institute to provide a research site for its Phase II clinical trial investigating psilocybin for major depressive disorder.
The FDA granted Breakthrough Therapy Designation to fast-track the study, with the regulator identifying that psilocybin-assisted therapy may offer a substantial clinical improvement over existing treatments.
In an exclusive interview about the announcement, PSYCH sat down with Dr Reid Robison, Chief Medical Officer at Novamind:
‘We were selected as a site for Usona’s Phase II psilocybin clinical trial for major depressive disorder,’ said Robison. ‘Psilocybin has received fast-track designation from the FDA for this evaluation and we’re honoured to participate in the research study to hopefully find new and improved ways of addressing serious mental health conditions.’
The World Health Organization estimates 280 million people experience major depressive disorder. PSYCH asked Robison what benefits psilocybin-assisted therapy could present to these patients.
‘As a psychiatrist I have spent most of my career doing clinical trials and looking for new and improved treatment modalities. I, like many others, have been quite discouraged by the available approved treatment options, especially for depression, and far too many people are left suffering.
‘There is a desperate need for new and improved ways of treating these conditions, especially depression which is one of the leading causes of disability worldwide.
‘The thing I find really exciting about the potential of psilocybin-assisted psychotherapy for depression is that it is targeting the underlying cause, rather than just treating symptoms alone.
‘In the preliminary studies, it was striking to see that a single dose of psilocybin with psychotherapy was not only able to significantly reduce depression in a number of individuals, but that this was a lasting change in many.’
COMPASS Pathways recently released data from its Phase IIb trial utilising psilocybin for treatment-resistant depression. On the surface this seems to be a similar trial, and PSYCH questioned whether there was a reason why this study was targeting major depressive disorder instead.
‘Both treatment-resistant depression and major depressive disorder are unique and serious concerns in and of themselves. If someone comes in with an episode of major depressive disorder and Usona is successful in obtaining approval for their medication, it will provide an option for treatment earlier in the process.
‘Whereas if a medicine is approved for treatment-resistant depression, there will be a requirement for a number of failed trials of antidepressant medications before it would be approved by insurance companies and made accessible to patients.’
PSYCH was eager to know if Robison was surprised to see COMPASS’s share price drop so steeply following its release of topline study data.
‘In my opinion it was due to a couple of factors, one being an incomplete understanding of both the complexities of treatment-resistant depression and the lack of really strong FDA-approved treatment options.
‘Another factor is that the market in general for psychedelic medicine stocks has been down in the past few months. I’m in it for the long haul and believe in the potential of these medicines. I have no doubt that this psychedelic medicine renaissance is bringing about meaningful changes in our options to treat mental health conditions.
‘I think investors do need to have some patience with the process. It’s not easy to develop a drug in the central nervous system space – period. I remain very hopeful about the potential of both psilocybin and MDMA and other medicines coming down the pipeline.’
Novamind expanded its clinic footprint in 2021 and by aligning with the Usona Institute reinforces its reputation in the industry. PSYCH asked Robison to speak to the organisation’s value proposition for investors.
‘We’re on a mission to raise the bar in mental health care by bringing innovative evidence-based treatment options to our clients. Part of that mission involves conducting clinical research and helping to accelerate the route to market for these new and improved treatment options.
‘We are building out the infrastructure to deliver these treatments once approved by participating in research studies and having trained clinicians and treatment teams experienced with psychedelic-assisted therapy. Aligning with Usona Institute is a highly strategic initiative on our path to bringing psychedelic medicines to the individuals who need them most.’
The company provides ketamine-assisted therapy and other mental health treatments to generate revenue as other psychedelic medicines await regulatory approval. The Psychedelics as Medicine Report has projected ketamine clinics will generate over US$230 million in revenue in 2023, Robison commented on Novamind’s business model.
‘We are treating people today using whatever evidence-based options we can. We are also very forward-looking and not only looking to what’s coming down the pipeline, but helping to pave the way for that. We are able to apply the lessons learned with ketamine to other psychedelic medicines as there exists a need to better understand how they work for different individuals and different conditions.
‘We are helping the field understand the best ways of pairing these medicines with psychotherapy, and it’s this kind of expertise that is appealing to the drug developers that want to partner with us.’
With MDMA and psilocybin expected to be regulated in 2023 and 2024 respectively, PSYCH asked the Novamind executive if the use of ketamine would subside in the future.
‘I’ve been working with ketamine for about eleven years now and can tell you with confidence that it’s not going away after MDMA and psilocybin are approved.
‘It fills an important need in psychiatry as a rapid antidepressant, with anti-suicidality properties, that elicits a brief and powerful psychedelic experience for many individuals. It has helped pave a path towards growth for our clients and accelerated their healing journeys in unique ways that may be complementary to both MDMA and psilocybin.
‘We have a very exciting pipeline of clinical research studies for the year ahead and I truly believe that 2022 is going to be a transformational year for psychedelic medicine. We are finally starting to see monumental shifts in how we approach mental health treatment that are long overdue. I am very grateful that the stars are aligning to improve the treatment landscape, and the public’s reception has just been phenomenal.’