Comments 1 - 13 of 13 Search these comments
But getting the green light from regulators is just the first in a series of hurdles for COMP360.
I think some guarantee of safety and potency, based upon a logical QA/QC testing process, would add value.
When I get cut off from booze I stop and lay down.
I am mostly a wino nowadays. One glass a night with dinner. My weapon of choice is sauvignon blanc, especially from New Zealand.
I’ve run the reds gamut, especilly Italian wines, but they generally put me to sleep so I stick with whites. I do like a decent chardonnay, but yeah, sauvingon blancs are my fave. I can relate to your MIL’s reaction. I once went to a well-regarded burger joint and all they had was Pinot Grigio and Rose'. I’m outta here.
Compass Pathways said Monday its psilocybin drug has cleared the first of two late-stage tests in a challenging form of depression as it advances toward the potential of becoming the first classical psychedelic on the market.
Patients treated with Compass’ COMP360 in a Phase 3 trial saw an average 3.6-point improvement on a depression symptom rating scale called the Montgomery-Åsberg Depression Rating Scale at six weeks versus placebo. Compass said Monday the result is both “statistically significant” and “clinically meaningful.”
Jefferies analyst Andrew Tsai previously told Endpoints News that a two-point difference is enough to secure FDA approval.
But in a previous interview with Endpoints, Compass’ former chief medical officer and now HMNC Brain Health CMO Hans Eriksson said most clinicians would want to see a minimum four-point difference.
The Phase 3 COMP005 trial enrolled over 250 people with treatment-resistant depression (TRD) across 32 sites in the US. The study looked at the effects of a single 25 mg dose of COMP360, which contains a synthetic version of the hallucinogenic compound found in magic mushrooms.
Compass plans to discuss the primary endpoint data with the FDA, but does not intend to file for approval until a second Phase 3 study reads out next year. That trial is testing three separate doses of COMP360 administered twice — including a sub-therapeutic 1 mg dose — in more than 550 patients with TRD.
An independent data safety monitoring board said there have been no unexpected safety findings or “clinically meaningful imbalances” in suicidality between arms across the two Phase 3 trials so far.
But getting the green light from regulators is just the first in a series of hurdles for COMP360. The drug’s commercial rollout and reimbursement prospects could present another challenge due to its high burden of administration. COMP360 treatment requires supervision by a healthcare professional for six to eight hours, as well as preparatory and integrative sessions.
Compass has said it plans to leverage the roughly 5,500 psychiatric treatment sites in the US that administer Johnson & Johnson’s ketamine-based depression treatment Spravato. But even that plan has its limitations, because Spravato only requires around two hours of supervision.
Meanwhile, the broader psychedelics field has attracted a recent boost in support from key figures in the Trump administration, including HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary. It has also started to see some consolidation, with atai Life Sciences and Beckley Psytech announcing plans to merge earlier this month.
https://endpoints.news/compass-reports-phase-3-depression-data-for-psilocybin-drug/