Psilocybin, the active ingredient in magic mushrooms, is often seen as a controversial compound due to its psychedelic properties. In recent years, however, more rigorous scientific studies could result in psilocybin cementing itself as a mainstream psychotherapeutic.
Psilocybin was first isolated by renowned Swiss chemist Dr. Albert Hofmann in 1957, and in 1958 it was produced synthetically for the first time. Hofmann was a researcher at Sandoz Pharmaceuticals, and the drug was branded as Indocybin and marketed for psychotherapeutic uses in the 1960s. However, the abuse and misuse in the drug scene brought many troubles for Sandoz, new legal restrictions classified the drug as Schedule I (illicit drug with no therapeutic benefit), and the pharma company abandoned the drug. As such, this R&D field has been on pause for decades and shunned by the medical community.
In 2001, the University of Arizona started the first psilocybin study in a patient population, targeting obsessive compulsive disorder patients, and as the saying goes, the rest is history. GlobalData’s Clinical Trials Database has identified that 18 clinical trials with psilocybin have been completed so far, while 21 are currently ongoing. As illustrated in the table below, psilocybin has potential in a wide range of neurology indications: from depression to migraine and various forms of addiction.
Currently, Compass Pathways has the most advanced clinical trial, studying psilocybin in treatment-resistant depression patients. On August 22, 2018, the company received the green light from the FDA for starting a Phase IIb dose-ranging study with 216 patients, the largest clinical study ever done with psilocybin, involving patients from research centers across Europe and North America. If successful, Compass will start a Phase III trial, with a view to file for approval in 2021.
The effectiveness of this hallucinogenic has been well-documented so far. Notably, a small double-blind study led by Johns Hopkins researchers demonstrated that about 80% of participants suffering from cancer-related depression or anxiety found considerable relief for up to six months from just a single dose of psilocybin. This is remarkable news considering that the vast majority of depression medications on the market can take weeks or months to show effects, and sometimes these are modest and come with damaging side effects. With this in mind, Compass is well-positioned to satisfy a major unmet need in mental health and stimulate further research of this compound.