- The company said that its COMP360 drug is the first classic psychedelic to consistently achieve a highly statistically significant result and a clinically meaningful effect.
- Compass said that across both Phase 3 trials to date, COMP360 has demonstrated a generally well-tolerated and safe profile, with no unexpected safety findings.
- The company added that a clinically meaningful reduction in MADRS of more than 25% was observed in a significant number of participants receiving the 25 mg dose in both COMP005 and COMP006 trials.
Compass Pathways PLC (CMPS) shares were up more than 23% in Tuesday’s pre-market trade after the company announced that it had successfully achieved the primary endpoint in a Phase 3 clinical trial.
Compass announced on Tuesday that its two Phase 3 trials have confirmed a highly differentiated profile for COMP360 for treatment-resistant depression (TRD).
Here Are Compass’ Findings
The company said that its COMP360 drug is the first classic psychedelic to consistently achieve a highly statistically significant result and clinically meaningful effect, with a generally well-tolerated and safe profile.
COMP360, a synthetic and proprietary formulation of psilocybin, is designed for TRD. Compass said that across both Phase 3 trials to date, COMP360 has demonstrated a generally well-tolerated and safe profile, with no unexpected safety findings.
The company reported that in COMP006, two doses of COMP360 with a dose of 25 mg versus a dose of 1 mg demonstrated a highly statistically significant and clinically meaningful reduction in symptom severity as measured by the Montgomery-Asberg Depression Rating Scale (MADRS.)
MADRS is a 10-item clinician-administered tool used to measure the severity of depressive episodes, ranging from 0 to 60. Compass said that the difference in the MADRS score between the 25 mg dose and the 1 mg dose was -3.8.
The company added that a clinically meaningful reduction in MADRS of more than 25% was observed in a significant number of participants receiving the 25 mg dose in both COMP005 and COMP006 trials. Compass said that COMP005 participants witnessed a 25% reduction in MADRS, while the reduction stood at 39% among COMP006 participants.
The company said that it has sought a meeting with the U.S. Food and Drug Administration (FDA) to discuss a rolling submission and review. It expects to complete a New Drug Application (NDA) submission in the fourth quarter (Q4).
“These data strengthen our conviction in the highly differentiated profile for COMP360 and given the urgent need for new treatments in TRD, we are advancing our discussions with the FDA, with the goal of submitting an NDA in Q4 and securing approval,” said Compass CEO Kabir Nath.
The company announced in January that the U.S. Food and Drug Administration (FDA) had accepted its Investigational New Drug (IND) application for COMP360 for the treatment of post-traumatic stress disorder (PTSD), allowing the company to begin a late-stage trial.
Compass said it is working on making COMP360 ready for commercial launch by the end of the year for TRD as well.
What Does Compass Do?
London-headquartered Compass is a biotechnology company engaged in the development of solutions for mental health conditions through its investigational COMP360 synthetic psilocybin treatment.
The company expects to release the 26-week Part B data from its COMP006 trial for TRD in the early third quarter (Q3) this year.
Here’s What Stocktwits Users Think
Retail sentiment on Stocktwits around Compass trended in the ‘extremely bullish’ territory, with message volumes at ‘extremely high’ levels. The CMPS stock was the second most trending ticker on the platform at the time of writing.
One bullish user called the trial results great, while adding that an FDA approval is “likely.”
Another user called the results huge news, while saying, “just imagine what different dosing regimens could reveal with this safety profile.”
CMPS stock is down 14% year-to-date, but up 27% over the past 12 months.
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