Compass Pathways preps first Phase 3 psilocybin study

Among psychedelic companies, Compass Pathways plc (Nasdaq: CMPS) is noteworthy for having received Breakthrough Therapy designation from FDA for psilocybin in treatment-resistant depression in 2018. Now, Compass has completed the design of a Phase 3 pivotal study to test its COMP360 psilocybin therapy in treatment-resistant depression (TRD).

The Phase 3 study will be the first Phase 3 trial to investigate psilocybin internationally.

London-based Compass Pathways will divide its Phase 3 program into three clinical trials, which it anticipates will begin by the end of the year.

The first pivotal trial will test a 25-mg dose of psilocybin monotherapy against a placebo in approximately 378 volunteers.

The second study will administer a fixed repeat dose (1, 10 and 25 mg) in three dose arms. The trial aims to determine whether a repeat dose can improve recipients’ response.

Both pivotal studies will use change in MADRS score as the primary…

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Compass Pathways names Big Pharma veteran as new CEO

Psilocybin-focused mental health company Compass Pathways (Nasdaq:CMPS) has seen its share price steadily decline since late last year. In early November, 2021, its share price flirted with reaching $50 per share. On July 18, CMPS shares closed at $13.02.

Today, however, the shares were up 6% in mid-day trading, hovering around $13.80, after the company announced it would install a new CEO on August 1.

Kabir Nath will replace the company’s current CEO and chairman, who will assume the role of executive chairman until the end of the year.

Kabir Nath

“I am grateful for this opportunity and excited to get to know all our teams here at Compass Pathways as well as the members of our community,” Nath wrote on LinkedIn, “This is an exciting time to be joining Compass and I can’t wait to see what we will accomplish together.”

Nath is a veteran of the life sciences industry, having held senior ro…

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Psilocybin therapy shows promise for treating anorexia and depression in small studies

Compass Pathways (Nasdaq:CMPS) announced positive data from two early studies focused on using psilocybin therapy for anorexia nervosa and severe treatment-resistant depression.

The London-based company presented the results at the Society of Biological Psychiatry Annual Meeting in New Orleans.

In the anorexia nervosa study, 10 patients received a single 25 mg of the company’s COMP360 synthetic formulation of psilocybin. Almost one-third (30%) of the patients had clinically significant reductions in eating disorder psychopathology after one month. That figure rose to 40% at three months.

A total of 90% of study volunteers reported that the clinical trial was meaningful and therapeutic.

Participants reported no serious adverse events.

Dr. Walter Kaye at the University of California San Diego School of Medicine oversaw the study.

The second treatment recruited 12 individuals with severe treatment-resistant depression who had not respon…

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