It turns out that giving psilocybin, the psychedelic ingredient found in magic mushrooms, to people who suffer from debilitating treatment-resistant depression is a good idea.
Compass Pathways, a U.K.-based clinical stage company that is developing a patented form of psilocybin to be used in conjunction with therapy, reported promising results from its much-anticipated phase 2b clinical trial this week. The study found that patients who took a single psychedelic dose of psilocybin, 25mg, in conjunction with therapy reported almost immediate and significant reduction in depressive symptoms that lasted weeks compared with patients who were given a 1mg dose, which is so low it’s essentially a placebo.
Twenty-nine patients, or 36.7%, who took the 25mg dose showed a 50% or more reduction in symptoms in three weeks after the single dose and again at three months, compared with the patients who took the placebo. Nineteen patients, or 24.1%, who took the highest dose were still in remission three months later, compared with 17.7% after three weeks and 10.1% after three months in the 1mg group.
George Goldsmith, who cofounded Compass Pathways with his wife and medical doctor, Ekaterina Malievskaia, and Lars Christian Wilde, says that when they saw the positive results, they realized they were “groundbreaking.”
“There’s one word that emerged: ‘Wow!’” says Goldsmith. “These people are very ill; this isn’t someone who gets the blues and wants to stay in bed one morning. This is a really big deal to see an immediate benefit in any kind of depression.”
The data from the study showed the two things they were hoping to see: high doses of psilocybin combined with therapy had rapid and sustained positive effects on many patients with treatment-resistant depression (TRD). Patients with TRD have tried two to four medications without success and many of them exhibit suicidal behavior and ideation.
The study, which included 233 patients with TRD, split patients into three groups: 79 were given a psychedelic 25mg dose, 75 were given a lower dose of 10mg, and 79 were given the placebo-like dose of 1mg. All patients in the study stopped taking their antidepressants prior to participation. It is thought to be the largest randomized, controlled, double-blind study of its kind and took place across 22 sites in ten countries and seven languages.
Compass Pathways, which is traded on the Nasdaq, is hoping to bring its molecule, Comp360, a patented high-purity polymorphic crystalline formulation of psilocybin, to market and gain approval by the U.S. Food and Drug Administration. COMP360 has been given Breakthrough Therapy designation by the FDA for TRD. The company’s largest investor is by Atai…