Companies in the Space
COMPASS is a UK-based biotech company pioneering a new combination therapy for treatment resistant depression that involves administration of the psychedelic drug psilocybin – named COMP360 – accompanied by psychological support. They consider themselves a mental health company first and foremost. They are the only company outside MAPS that is this advanced regarding getting psychedelic medicine through clinical trials. In many ways, compass kick-started the retail investor’s interest in psychedelic medicine. They were the first psychedelic company that got listed in the NASDAQ. (link to podcast)
Compass also offers a therapist training program for mental health professionals interested in working with psychedelics and has been approved by the FDA for research purposes. The company hopes to bring a combination of the psychedelic drug psilocybin and psychological support to market. “The FDA has never approved a drug in combination with a therapy before, and yet Compass Pathways has received breakthrough therapy designation in 2018, which is only granted when a therapy is significantly better or potentially significantly better than the standard of care.” (link to podcast)
Even while Compass has seen some steady progress in the clinic, its share price has nose-dived, sinking 72% over the past 12 months.
Psilocybin is currently classed as a schedule 1 drug which means both the FDA and DEA do not see any medical benefit. Compass’ challenge is to change their mind.
Exploring The Potential Of Psilocybin Therapy From George Goldsmith & COMPASS Pathways
I have also added this Business Trip podcast interview with Lars Wilde, a COMPASS co-founder. I thought he was very articulate and gave a lot of information about the company and the general direction psychedelic therapy is heading towards. Highly recommend!
Controversy around Compass:
“In a community long dominated by true believers, however, the possibility of profit is a new and destabilizing force. Hence the controversy around Compass Pathways Plc. Initially founded as a nonprofit mental health company in 2015, Compass funded important early research projects and had the vocal support of Doblin and several prominent psychedelics researchers. Then, in 2018, it began taking out patents, mostly concerning a specific form, or polymorph, of synthesized psilocybin. It also filed patents for a psychedelic therapy technique, going so far as to claim that aspects of clinic decor—“soft furniture,” “muted colors,” “a high-resolution sound system”—are, because they are key to Compass’s proprietary therapy, therefore proprietary themselves.
The company’s executive chairman and co-founder, George Goldsmith, defends these moves as the best way to bring a promising treatment to the masses. Compass, he argues, has the potential to transform mental health, but not if it can’t make money. “The cost of doing that at scale through a regulated model is unfortunate but true,” he says. “There’s no way to do discounted clinical trials.” The company’s critics, he argues, are part of a “cult.”
For those critics—among them former supporters—this newly aggressive intellectual property strategy threatens to throttle the nascent market. “This is a bit like somebody saying we’re going to patent the phrase ‘Hail Mary,’ ” says the investor and philanthropist Carey Turnbull, who founded a nonprofit called Freedom to Operate to contest the company’s claims. Experts in physical chemistry and crystallography his group hired found that Compass’s synthesized molecule was not, in fact, new, but a patchwork of older polymorphs. In June of this year, the US Patent Trial and Appeal Board denied Turnbull’s petitions for “post-grant review” of Compass’s patents.
As all this unfolded, Compass went public on Sept. 18, 2020. On the first day of trading, it attained a market value of nearly a billion dollars. Last December, after the company presented the results of its largest trial of psilocybin therapy to date, its stock price peaked at $58. The trial results, however, at least in the heady context of other recent studies, were mixed. Patients with treatment-resistant depression who received a dose of Compass’s psilocybin drug COMP360 all saw a significant improvement in symptoms. About one-third of patients in a high-dose group showed a decline in the severity of their depression after 12 weeks. But so did 10% in a control group. (A quarter of patients in the high-dose group no longer appeared to suffer from depression at all.) The trial also raised safety concerns, with some participants experiencing suicidal impulses. “There’s been theoretical fears that the nature of the ‘trip’ might be beneficial for many but problematic for a subset,” Paul Matteis, the managing director for biotech equity research at Stifel, wrote in a research note at the time. Compass’s stock has steadily declined over the past year and a half and was worth about $17.50 a share in mid-August.” (view full article here – it is great!)