Exasperated with the often-ineffective existing slate of antidepressants, COMPASS Pathways set up shop in London 2016 — and made a beeline for psilocybin, the psychoactive ingredient in magic mushrooms.
On Wednesday, the startup said its man-made version of the chemical — which is illegal across geographies in its natural fungi form — had been well-tolerated in an early-stage, placebo-controlled trial in 89 healthy volunteers.
Although previous research supports the use of psilocybin in relieving symptoms of depression, smaller studies are not always placebo-controlled. The trial testing the COMPASS compound is the largest controlled study of psilocybin to date, said the study’s lead investigator, James Rucker of King’s College London’s Institute of Psychiatry, Psychology & Neuroscience, in a statement.
Existing antidepressants typically come in a pill form, and take weeks to kick in. J&J’s pharmaceutical concoction of ketamine — the notorious party drug that is also a horse and cat tranquilizer — was approved earlier this year, comes in the form of a nasal spray.
In the COMPASS trial, volunteers were randomized to receive a 10 mg or 25 mg dose of the synthesized chemical (encapsulated in a pill) or given placebo. Once dosed, volunteers were given individual support from therapists in groups of six in sessions that lasted up to six hours.
The patients who got the drug will most likely have experienced some psychedelic effect, which is why the therapists were available on hand, COMPASS’ chief communications officer Tracy Cheung noted in an interview with Endpoints News.
“Sometimes that can be a little bit frightening or a little bit intense and the therapist is just there to hold your hand if that’s what’s required and just provide some support or just to kind of say it’s all right, I’m here.”
No serious adverse events emerged, and the most common side effects — as expected — were in the psychedelic realm, including changes in sensory perception. The compound, dubbed COMP360, also had no impact on cognitive and emotional functioning, the company said.
COMPASS is also conducting a Phase II trial testing its psilocybin compound in 216 patients with treatment-resistant depression across sites in North America and Europe. The company expects to report data from this study, which does not include a placebo arm, by early 2021.
Psilocybin is a substance that in most regions is classified as having no medicinal value, falling in the same category as chemicals such as LSD.
“At the moment…we can use it but there’s an awful lot of paperwork and we have to get licenses for each of the countries that we’re working on doing the clinical trial,” Cheung said, noting that the company has raised £28 million so far to investigate the drug.
Psychoactive ingredients, whether derived from cannabis, LSD or magic mushrooms, have long captivated mental health researchers. Navigating the complex legal hurdles to access these compounds has thawed the pace of research but with motivated scientists and a growing burden of poorly treated mental health conditions, the ecosystem of psychedelic research has exploded. In September, John Hopkin’s unveiled it had scored $17 million to open its very own center of psychedelic research to explore the impact of psychedelic compounds on creativity and well-being.
But the brimming enthusiasm comes with a healthy dose of skepticism. Critics worry that the burgeoning research could incentivize unbridled use of non-pharmaceutical versions of these drugs and that clinical trial data could be clouded by the fact that placebo-controlled studies are not necessarily double-blinded, because it is far too easy to determine which group of patients have been given a placebo.