Trial of Psilocybin Therapeutic in Treatment Resistant Depression Yields Positive Topline Results

Source: Streetwise Reports   11/14/2021

“We believe this data begins to form the basis of an approvable program for Compass Pathways’ COMP360” in this indication, noted a BTIG report.

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.

Disclosures:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures for BTIG, Compass Pathways, Nov. 9, 2021

Analyst Certification
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)

The research analyst(s) responsible for the preparation of this report receives compensation based upon a variety of factors, including the quality and accuracy of research, internal/client feedback, and overall Firm revenues.

Facts, views or opinions presented in this report have not been reviewed by, and may not reflect information known to, employees or other professionals in the “BTIG Group” (BTIG Group includes, but is not limited to, BTIG and its parents, subsidiaries and/ or affiliates). BTIG Group employees, including Sales Representatives and Traders, may provide oral or written commentary or advice that may be inconsistent with the opinions and/or views expressed in this research report. BTIG Group employees and/or its affiliates not involved in the preparation of this research report may have investments in securities or derivatives of securities of companies mentioned in this report that are inconsistent with the views discussed in this report.

Investors in securities products bear certain risks in conjunction with those investments. The value of, and income from, any investments may vary because of changes in interest rates or foreign exchange rates, securities prices or market indexes, operational or financial conditions of companies or other factors within or beyond the companies’ control. Investments in securities may pose significant risks due to the inherent uncertainty associated with relying on forecasts of various factors that can affect the earnings, cash flow and overall valuation of a company.

Any investment in securities should be undertaken only upon consideration of issues relating to the recipient’s overall investment portfolio and objectives (such as diversification by asset class, industry or company) as well as time horizon and liquidity needs. Further, past performance should not be taken as an indication or guarantee of future performance, and no representation or warranty, express or implied, is made regarding future performance. There may be time limitations on the exercise of options or other rights in any securities transactions.