Compass Pathways Archives - Medical Design Sourcing

Compass Pathways names board member at pivotal moment for psychedelic industry

Compass Pathways has named biotech exec Daphne Karydas to its board. Karydas is the president and chief financial officer of Flare Therapeutics Inc., which is developing drug discovery programs targeting transcription factors for cancer and other diseases. Signs point to a potential FDA approval of psilocybin and MDMA under strict controls in the coming years, but the psychedelic therapy market has seen significant volatility in recent years. Since the company went public in September 2020, Compass has seen its valuation drop by more than two-thirds. Its stock, however, has shown some recent resilience rebounding by 17.49% year-to-date.

The volatility isn’t unique to Compass. Fellow psychedelic stock company ATAI Life Sciences NV (NASDAQ:ATAI) has seen its valuation plummet by 93% since its debut in mid-2021. The market fluctuations mirror the challenges of navigating the psychedelic therapy space, increasing the need for seasoned leadership.

In addi…

The psychedelic neuroplasticity and safety conundrum: Reaping the rewards of neuroplasticity with caution

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Evidence continues to build that serotonergic psychedelics such as psilocybin, DMT, and LSD promote neuroplasticity. Cortical atrophy is involved in the development of a broad swathe of neuropsychiatric conditions ranging from depression to substance use disorder. But it remains unclear how psychedelics may potentially treat mood disorders and other conditions. Despite their therapeutic potential, these compounds continue to remain unpopular in some quarters and could be contraindicated for many individuals even if they ultimately win regulatory approval.

Drug developers, such as Boston-based Delix Therapeutics and Onsero Therapeutics, aim to develop compounds that trigger neuroplasticity in what they deem to be a safer and more accessible therapeutic option than classic psychedelics.

Meanwhile, players such as Compass Pathways (Nasdaq:CMPS) and Small Pharma (CVE:DMT), are wo…

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…

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…

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…