Compass Pathways stock plunged Tuesday, even as the London-based psychedelic-drug developer said a strong dose of its psilocybin-based drug helped reduce depression in treatment-resistant patients after three weeks in a Phase 2b trial.
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Compass Pathways (CMPS) said that a 25-milligram dose of its Comp360 medication — a crystalline form of psilocybin taken in the form of an oral capsule, accompanied by headphones and an hours-long song playlist of largely classical music — showed a “highly statistically significant and clinically relevant reduction” in depression-symptom severity over that time.
“The medicines they take, quite frankly, quite often don’t work,” George Goldsmith, Compass’ CEO, said of patients with treatment-resistant depression. “That’s why they’re called treatment-resistant.”
The findings are the latest pointing to the potential for psychedelic drugs to treat mental-health issues like depression, anxiety and PTSD. But the exact reason for the sharp drop in Compass Pathways stock was unclear.
Some analysts called the decision to sell misguided. But one analyst noted investors’ concerns around the treatment’s durability twelve weeks out.
“People who really did not grasp the significance of the data, they decided to sell,” Roth Capital Partners analyst Elemer Piros said in an interview.
233 Patients, 10 Nations, 7 Languages
In the trial, researchers gave that single dose to 233 patients, who also received support from therapists. The trial took place in 22 sites, in seven languages across 10 nations, including Canada, the U.S., the UK and several others in Europe. Ninety-four percent of the patients hadn’t used psilocybin, the hallucinogenic compound in magic mushrooms. Researchers monitored patients’ progress for 12 weeks.
“In this groundbreaking study, a single dose of psilocybin, given in conjunction with psychological support, generated a rapid response that lasted up to 12 weeks,” David Hellerstein, a principal investigator on the trial, said in a statement. “Remission rates appear to be higher than seen in traditional medication studies.”
Trial Objectives
Compass, which is backed by billionaire investor Peter Thiel, has been trying to measure the medication’s impact on patients with treatment-resistant depression. Treatment-resistant depression is considered to be depression that doesn’t fade after at least two anti-depressive treatments.
The objective of the trial was to gauge the right dose size for a bigger Phase 3 trial, set to begin next year. The primary endpoint, or outcome, of the trial was to see if 25 milligrams of Comp360 could ward off treatment-resistant depression in three weeks. The secondary endpoint revolved around its effects over 12.
Compass’s Comp360 treatment regimen received breakthrough therapy designation from the FDA in 2018. The FDA has approved Johnson & Johnson’s (JNJ) Spravato, which uses a derivative of ketamine, for treatment-resistant depression and people who are actively…
Read more:Compass Pathways Goes On Bad Trip, Even As Trial Shows Promise