Evidence of durability of psilocybin-based COMP360 is a key point for the FDA, according to Compass Pathways Chief Medical Officer Guy Goodwin. By providing 26 weeks’ worth of such data instead of the requested 12, the company is delivering “in spades,” he said.
New data from two late-stage trials of Compass Pathways’ psilocybin-based therapy for treatment-resistant depression point to a clear path to the FDA, with both executives and analysts lauding durability data and a consistent safety profile.
The Phase 3 COMP006 trial of COMP360 “clearly met the Street’s bar for success,” Stifel analysts said in a note to investors Tuesday morning, “with overall dataset derisking . . . approval.” Compass’ stock jumped almost 33% to $7.74 on Tuesday morning.
The highly anticipated trial hit its primary endpoint, with two 25-mg doses of COMP360 given three weeks apart eliciting a 3.8 point change on the Montgomery-Åsberg Depression Rating Scale (MADRS)— a key measurement of the severity of depressive episodes—compared with participants who received 1 mg of the drug after six weeks of treatment. This equated to a “highly statistically significant reduction in symptom severity,” according to Compass’ Tuesday press release.
Compass also revealed 26-week data from the Phase 3 COMP005 trial, in which a single administration of the candidate previously drove a 3.6-point MADRS reduction at six weeks. The company emphasized that COMP360 “maintained durability of effect at least through week 26 after just one or two doses.”
On an investor call Tuesday morning, Lori Englebert, chief commercial officer at Compass, called this “perhaps the most impressive” takeaway of the trial.
“This is highly differentiated versus Spravato,” Englebert said, noting that Johnson & Johnson’s inhaled esketamine treatment, approved for treatment-resistant depression (TRD) in 2019, requires dosing every one to two weeks to maintain durability “following the high burden of 12 initial treatments.” Spravato is widely viewed as Compass’ main competitor in the TRD space.
Evidence of durability is also a key point for the FDA, Chief Medical Officer Guy Goodwin added on the call. “We’re providing that in spades,” he said, noting that the agency had requested only 12 weeks of durability data.
After 26 weeks of treatment with COMP360 in the COMP005 trial, 40% of patients who had at least a 25% reduction on MADRS and received a second dose went into disease remission, Steve Levine, Compass’ chief patient officer, said during the investor call.
“[This] tells us not only that this group had a very meaningful initial response, but a second dose might deepen that,” Levine said.
Stifel also noted this apparent durability benefit, saying that “early insights into durability look favorable, suggesting that patients who benefit early tend to fare well over time.”
As for safety, findings from these latest data readouts “are consistent with previous studies of COMP360 and there are no new, unexpected or concerning safety findings,” the chair of the trials’ independent Data Safety Monitoring Board said in a statement in Compass’ press release.
However, Stifel noted that “there [were] a few cases of suicidal ideation.”
The “small handful of suicidal ideation events” occurred at the 25-mg dose, the analysts wrote. But Compass management noted that two of these cases were in nonresponders and the other three were “more transient/resolved within the first day of treatment,” according to Stifel.
Compass has requested a meeting with the FDA to discuss a rolling NDA submission, which is expected to be complete in the fourth quarter this year.
“If approved, COMP360 will be the first to market in a highly anticipated new class,” Englebert said.
Given psilocybin’s current Drug Enforcement Administration classification as a Schedule 1 drug, however, a potential launch could be delayed, H.C. Wainwright analyst Patrick Trucchio told BioSpace earlier this month. Even if Compass were to submit an NDA following the 26-week data released today, a fourth-quarter 2027 launch would be “optimistic,” he noted.
