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Compass, with Phase 3 hits, ready to take psilocybin to the FDA
A psychedelic medicine for hard-to-treat depression could be under approval review before the end of this year, now that its developer has scored positive data from another large clinical trial. Compass Pathways, a London-based biotechnology company, said Tues
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A psychedelic medicine for hard-to-treat depression could be under approval review before the end of this year, now that its developer has scored positive data from another large clinical trial. Compass Pathways, a London-based biotechnology company, said Tuesday it has asked to meet with the Food and Drug Administration to discuss a “rolling” submission of its synthetic form of psilocybin — a hallucinogen-inducing compound found in certain mushroom species — sometime in between October and December. Should the FDA accept that application and ultimately grant approval, the compound would become the first “classic” psychedelic cleared for the U.S. market. Backing Compass’ position are two late-stage studies that each enrolled hundreds of people with treatment-resistant depression. Results from the first of those experiments, which tested one dose of the compound against a placebo, came last summer. Though positive, they didn’t live up to investor expectations , leading to a major stock sell off and Compass losing nearly half of its market value. Company shares have more than rebounded since, and at one point spiked more than 50% higher Tuesday morning, to just under $9 apiece, with the release of data from that second, twice-as-large trial . There, researchers evaluated two doses of Compass’ medicine, codenamed COMP360, against a far smaller dose that acted as a control group. Such a design can help address “unblinding,” a well-documented concern with psychedelics studies where participants deduce what arm they’ve been assigned to based on whether they’re experiencing the test drug’s mind-altering properties. According to Compass, six weeks into the trial’s treatment period, patients on the highest dose of COMP360 scored an average 3.8 points lower than those in the control group, on a 60-point scale where bigger scores signal more severe depression symptoms. Compass also said almost 40% of participants in the higher dose arm experienced a “clinically meaningful reduction” in depression scores at that time point. Among those patients, researchers saw a “statistically significant rapid onset” of the drug’s effect, starting the day after administration and lasting through the six weeks. Compass expects 26-week data to become available in the third quarter. Across both experiments, the company has relied on an independent board of experts to assess safety. This board, Compass said, views the safety data seen thus far as “consistent” with earlier studies. No new, unexpected or concerning findings have arisen, including no evidence of a “clinically meaningful imbalance” between treatment arms in suicidality. “This is a remarkable achievement for the field of psychiatry — especially in the TRD population, where proving benefit has historically been extraordinarily challenging,” said Compass CEO Kabir Nath in a statement. “These data strengthen our conviction in the highly differentiated profile for COMP360,” he added. Wall Street shared that enthusiasm. Ritu Baral, an analyst at TD Cowen, wrote in a note to clients that her team strongly believes Compass’ drug will get approved and will have “robust market uptake” thanks, in part, to a “feasible” risk-mitigation strategy. The fresh results “clearly met the Street's bar for success,” according to Paul Matteis of Stifel. Analysts have debated how COMP360 might compete against Johnson & Johnson’s Spravato , a nasal spray form of ketamine that the FDA greenlit in 2019 for treatment-resistant depression. Spravato has, since its approval, become one of J&J’s fastest-growing products, with sales increasing 57%, to $1.7 billion, last year. Spravato , because of its ketamine base and effects on the brain, isn't considered a "true" psychedelic like psilocybin. Matteis acknowledged that investors may still nitpick Compass’ data, on measures like the number of participants who were partial versus full responders, or how the overall package stacks up to Spravato’s. His teammates, however, “are less focused on the actual raw numbers and more focused on the fact that the trials worked and the drug appears safe — it's important to remember that many antidepressants, including Spravato, have been commercially successful despite multiple failed trials and COMP360 is 3-for-3,” Matteis wrote in his own note.