COMPASS Pathways plc (Nasdaq: CMPS) introduced optimistic outcomes from its exploratory examine of COMP360 psilocybin remedy at the side of SSRI use. The examine wished to check whether or not sufferers with treatment-resistant despair may tolerate and do nicely with psilocybin remedies whereas additionally taking common despair medication.
“The outcomes of this examine problem the widely-held perception that the usage of SSRI remedy along with psilocybin may intrude with psilocybin’s therapeutic impact. Our findings present a powerful sign that COMP360 psilocybin remedy could possibly be an adjunctive remedy to SSRI antidepressants in addition to a monotherapy. For some sufferers with treatment-resistant despair, withdrawal is a tough step despite the fact that, by definition, ‘treatment-resistant’ signifies that these antidepressants aren’t working. That is precisely why we conduct rigorous analysis to assist information our medical trial design – together with addressing boundaries to adoption of COMP360 remedy,” said Man Goodwin, Compass Pathways’ Chief Medical Officer. “We at the moment are trying ahead to assembly with the FDA early within the new yr in mild of those new knowledge to finalize our plans for the section III program, which we count on to start in Q3 2022.” Compass has Breakthrough Remedy designation with the FDA.
Compass stated in an announcement that the open-label examine included 19 sufferers from medical websites in Eire and the USA. The vast majority of sufferers had been feminine (68.4%) and the common age was 42 years. The first endpoint was the change in baseline MADRS1 whole rating at 3 weeks in sufferers having 25mg COMP360 psilocybin remedy given in augmentation with their present SSRI antidepressant routine. Within the examine, 8 of the 19 sufferers (42.1%) had been responders1 at week 3 (in contrast with 36.7% at week 3 within the section IIb trial) and all 8 had been additionally remitters1. The imply discount from baseline noticed in MADRS whole rating was 14.9 at week 3 (in contrast with a 12.0 imply discount in MADRS within the section IIb trial). There was a fast response from day 2 to week 3 after COMP360 remedy, which can also be according to the section IIb consequence. The baseline MADRS rating of sufferers coming into the examine was 31.7, representing average to extreme despair. MADRS scores had been assessed by blinded unbiased raters at baseline, on the day following COMP360 psilocybin remedy, and at weeks 1, 2 and three. Sufferers had been then invited to take part in COMPASS’s long-term follow-up examine which additionally consists of sufferers from the section IIb trial.
COMP360 psilocybin remedy utilizing a 25mg dose additionally confirmed total indicators of enchancment in most different measures together with enchancment in nervousness, clinician and self-rated depressive signs, and optimistic and adverse have an effect on.
In response to Compass, greater than 320 million folks globally undergo from main depressive dysfunction (MDD). A couple of third of those sufferers – 100 million folks – aren’t helped by present therapies and undergo from treatment-resistant despair (TRD). As many as 30% of those try suicide at the very least as soon as throughout their lifetime. TRD carries two to 3 occasions the medical prices of a non-TRD MDD affected person, and sufferers with TRD have larger all-cause mortality in contrast with non-TRD MDD sufferers. The TRD inhabitants is by definition harder to deal with and extra more likely to relapse than sufferers with main depressive dysfunction. In 2018, COMPASS acquired FDA Breakthrough Remedy designation for its COMP360 psilocybin remedy for TRD.
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