Topline results were positive from Compass Pathways Plc's (CMPS:NASDAQ) Phase 2b clinical trial of its novel version of psilocybin, COMP360, in treatment resistant depression, and these data are "important for the company and for the psychedelic field," BTIG analyst Bert Hazlett wrote in a Nov. 9 research note.
Hazlett reviewed the basics of the 233-patient study. It tested 25 milligrams (25 mg) and 10mg of COMP360 against an ineffective 1 mg COMP360 dose, administered once. After, patients were monitored for 12 weeks. The study's primary endpoint was a reduction in patients' total Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline, at week three.
Hazlett presented the key findings from three data sets, efficacy, sustained response and remission, all of which showed 25 mg of COMP360 produced results. He wrote that these all of these data will be important for the acceptance of COMP360, and they should help inform Phase 3 work.
In terms of efficacy, the analyst relayed, primary endpoint data showed the 25 mg dose to have a statistically significant result of minus 6.6 points (p<0.001) when compared to results of patients given 1 mg. Also, 25 mg showed a rapid and durable response from day two through week six as well as evidence of antidepressant activity to week 12.
Sustained responder results revealed that more patients in the 25 mg dose cohort than in the 1 mg cohort achieved this state, 24.1% versus 10.1%, respectively. Sustained responders met MADRS response criteria at weeks three and 12, met it at least once in weeks six or nine and did not start new depression treatments.
MADRS responders were patients who experienced a greater than 50% decrease in their total MADRS score. At week three, 36.7% of the 25 mg dose recipients fell into that category and at week 12, 32.9% did. In comparison, MADRS responders among the 1 mg dose recipients at the same time points were 17.7% and 16.5%, respectively.
The final set of results pertained to remission, or having a MADRS score of less than 10 at weeks three and 12. Of the 25 mg cohort, 29.1% and 26.6% showed remission at week three and week 12 respectively, compared to 7.6% and 11.4% of the 1 mg cohort
Regarding the safety of COMP360, patients in the 10 mg cohort experienced the most serious treatment-emergent adverse events (8% of them), followed by the 25 mg patients (6.3%) and lastly, the 1 mg patients (1.3%). When it came to suicidal behavior one month out from dosing, all of the patients who experienced it were in the 25 mg group (3.8% of them).
In other news, Hazlett reported, Compass Pathways reported results of another study of COMP360, this one evaluating 25 mg in 30 cancer patients with depression. Two to four of the patients received both psilocybin and one-on-one therapy. On average, patients' MADRS score dropped 19.1 points from baseline, 24 patients were sustained responders and 15 achieved remission.
BTIG has a Buy rating and a $63 per share target price on Compass Pathways, the current share price of which is about $43.06.
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Disclosures for BTIG, Compass Pathways, Nov. 9, 2021
I, Robert "Bert" Hazlett, hereby certify that the views about the companies and securities discussed in this report are accurately expressed and that I have not received and will not receive direct or indirect compensation in exchange for expressing specific recommendations or views in this report.
BTIG LLC expects to receive or intends to seek compensation for investment banking services in the next 3 months from: COMPASS Pathways plc (CMPS)
BTIG LLC had an investment banking services client relationship during the past 12 months with: COMPASS Pathways plc (CMPS)
BTIG LLC managed or co-managed a public offering of securities in the past 12 months for: COMPASS Pathways plc (CMPS)
BTIG LLC has received compensation for investment banking services in the past 12 months from: COMPASS Pathways plc (CMPS)
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