Psychedelics come of age
By Cape Capital
Psychedelics reset the brain through dream-like experiences—Sean McLintock believes they are the next big medical breakthrough for mental health
Perhaps best-known as the hallucinogenic, trippy narcotic of choice at underground raves in the 1960s, in recent years, psychedelics—which were classified as Schedule 1 drugs a decade later, effectively restricting all medical research—have re-emerged as a potential life-changing treatment for those with mental health and chronic pain issues.
‘The reason we are looking for alternatives is the scale of unmet need,’ says Sean McLintock, a founding partner of Neo Kuma Ventures, which invests in early-stage psychedelic healthcare companies.
According to the World Health Organisation, around 280 million people globally suffer from depression, and of these, King’s College London states that approximately a third have treatment-resistant depression (meaning they haven’t responded to at least two types of antidepressants). Even prior to Covid-19, a World Economic Forum report calculated that poor mental health is estimated to cost the economy over a trillion dollars per year in lost productivity.
‘SSRIs, a class of drug commonly used to treat depression and anxiety, build up the level of serotonin in the brain over time but they only cover up the symptoms of someone’s underlying trauma and have limited efficacy. Psychedelics are different in that they can reset the root cause,’ continues Sean.
'She kicked alcohol and stayed sober until the end of her life. It woke me up to the potential of these medicines’
He first became interested in the subject after his late mother struggled with alcoholism. ‘We tried everything as a family and nothing worked. Then, when I was 22 and finishing my law degree in South Africa, I read about a microdosing study in Switzerland on psilocybin, the active ingredient in magic mushrooms. She took part and afterwards was a completely different person. She kicked alcohol and stayed sober until the end of her life. It woke me up to the potential of these medicines.’
Psychedelics alter perception and mood by promoting new pathways between neurons. ‘The best way I’ve heard it described is like shaking a snow globe and when the flakes settle, they are in different patterns,’ says Sean. The experience of taking them is often likened to being in a spiritual, mystical, dreamlike state. ‘Brain-imaging studies are helping us to understand what is happening, not only in psychedelics but also in dream states.’
Three key psychedelics have been given rare breakthrough status by the Food and Drug Administration (FDA): ketamine, MDMA and psilocybin. Of these, the only one that is available so far is Spravato, a ketamine-based nasal spray brought to market by Johnson & Johnson and authorised for use in Europe, the US and Canada to reduce symptoms in patients with major depressive disorder. It’s also accessible off-label, which means that although it’s not approved for other indications, it is allowed to be used because it’s deemed safe.
Then there’s MDMA, which is being trialled by the Multidisciplinary Association for Psychedelic Studies (MAPS). It has passed its second Phase 3 trial which resulted in 67 percent of participants given the drug no longer meeting the diagnostic criteria for PTSD after three sessions, compared with 32 percent of those in the placebo group. ‘That should be in the market within 18 months and will be a massive catalyst for the industry,’ says Sean. ‘It’s going to get really serious for psychedelics after that.’
Finally, the end of last year saw the results of the largest trial of psilocybin to date, led by COMPASS Pathways and published in The New England Journal of Medicine. It showed that after a single dose of psilocybin therapy, around 30 percent of patients with treatment-resistant depression were in remission at week three. If the trials continue to progress well, that should be on the market in around four years.
‘There are around 50 drugs currently undergoing clinical trials and most of these are happening in the US, which is the biggest market for any drug,’ says Sean. ‘After the US, we expect the EU and the UK to be the second and third largest markets for psychedelics. We’re also seeing interesting stuff happen in countries like Australia where, from July this year, therapists can request approval to treat patients with either psilocybin or MDMA for mental health conditions.’
'It’s easy to box psychedelics off as wacky'
The research renaissance was kickstarted at the beginning of this century by doctors affiliated with Johns Hopkins University in the US. It continued at Imperial College London and then proliferated around the world as credibility grew.
‘It’s easy to box psychedelics off as wacky but many of those working in this area have strong backgrounds in neuroscience. What we’re seeing is an application of some of the world’s best and brightest minds to understand these drugs,’ says Sean, who is working with a number of government lobbying institutions that are trying to change the scheduling of psychedelics at UN level. ‘This has combined with people travelling to places such as Peru, Brazil and Costa Rica to have these treatments in a legal setting. Anecdotal reports coming back to the mainstream and social media spurred a social momentum which has latched onto the scientific interest and now we’ve seen a lot of regulatory and legislative momentum follow suit.
However, he draws a clear distinction between those who are treated medically by an approved drug versus legalised retreats or recreational use. ‘Legalised retreats are not what we invest in. While some are brilliant businesses offering strong guidance and support to their clients, that is not the side of the industry we support. We’re for the use of these drugs in a very controlled clinical setting. I think when you put it in that context and look at the efficacy results of the scientific studies, it’s very difficult for a politician or regulatory arm to not want to take them forward.’
Nevertheless, one of the major roadblocks to psychedelics is still their perception amongst psychiatrists, general practitioners, and psychologists. ‘They are going to be the ones advocating these treatments on the ground so I think greater education and communication of the efficacy of the trials is needed. The hurdle of winning over clinicians who are used to prescribing SSRIs as a frontline treatment is going to take time,’ he says.
Sean cites other hurdles, including the expense of clinical trials; the need for companies to partner with pharmaceuticals who will have to be convinced of the commercial value of psychedelics; and, perhaps biggest of all, the need to train clinicians in this new type of combination therapy. ‘With psilocybin for instance, patients usually have a six-hour session with two therapists and that’s burdensome on the healthcare system. The roadblock will be justifying that upfront cost as a pay-off compared to the drugs someone would take throughout their lifetime,’ he says.
The potential reward though, is great. He concludes: ‘We’re working towards a world where if you’re suffering from a condition like PTSD or depression, there are a number of treatment options. None of them are a silver bullet but in the next decade more will enter the medical arena and be widely adopted—and that’s a positive thing.’