Compass Pathways plc (Nasdaq: CMPS) (“Compass”), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, and Mindful Health Solutions (MHS), one of the US’s leading providers of innovative behavioral health care, today announced that they have entered into a research collaboration agreement to inform the development of a scalable and cost-effective delivery model for COMP360 psilocybin treatment, if approved for treatment-resistant depression (TRD). This is the latest of several collaborations for Compass, intended to better understand a range of potential approaches to deliver COMP360 to patients in different care settings.

MHS offers comprehensive mental health care services for patients living with TRD and other mental health conditions. They focus on early adoption of advanced, interventional treatment options, as part of a long-term, holistic care model that includes medication management and psychotherapy. MHS operates over 20 outpatient clinics located across California, Washington, Texas, and Georgia.

“It is crucial that we understand how different mental health service providers are positioned to deliver COMP360 psilocybin treatment to patients, should it receive FDA approval,” said Kabir Nath, CEO of Compass Pathways. “By joining forces with MHS, Compass will have the opportunity to learn from a leading provider of innovative behavioral health care for people living with treatment-resistant depression and other difficult-to-treat mental health conditions.”

The collaboration with MHS will include an in-depth information exchange on Compass’s potential delivery model for investigational COMP360 psilocybin treatment, and how it might fit into a healthcare delivery system similar to MHS. Compass and MHS will chart the depression and TRD patient pathway, and investigate challenges with the current patient care experience, including potential approaches to address these. MHS will complete training and learning sessions on Compass’s psychological support model and therapist training program and conduct research to better understand therapist training needs. Compass and MHS will exchange information on model treatment rooms, site activation services, and coding and reimbursement considerations related to psychedelic treatments.

“There are millions of people in the US living with depression for whom existing treatments do not work,” said John Minahan, CEO of Mindful Health Solutions. “Part of MHS’s mission is to make innovative treatments accessible to everyone who may benefit from them. As such, we are proud to collaborate with Compass Pathways and to contribute to learning how COMP360 psilocybin treatment may be most effectively delivered to patients, if approved for TRD.”

Compass has previously announced research collaboration agreements with Greenbrook TMS, a leading provider of interventional psychiatric treatments such as transcranial magnetic stimulation; Hackensack Meridian Health, a leading not-for-profit health care organization and the largest, most comprehensive and truly integrated network in New Jersey, addressing the full continuum of care for people living with TRD; and Journey Clinical, a leading psychedelic-assisted psychotherapy platform with the largest network of licensed therapists focused on psychedelics in the US.

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About Compass Pathways

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).

We have commenced a phase 3 clinical program of COMP360 psilocybin treatment in TRD, the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single 25mg dose of COMP360 psilocybin with psychological support. We are also conducting phase 2 clinical studies of COMP360 psilocybin treatment for post-traumatic stress disorder (PTSD) and anorexia nervosa.

Compass is headquartered in London, UK, with offices in New York and San Francisco in the United States. Our vision is a world of mental wellbeing. www.compasspathways.com.   

About Mindful Health Solutions

Mindful Health Solutions (mindfulhealthsolutions.com) is a leading provider of innovative behavioral health care in the US, with a focus on emerging psychedelic research, precision medicine, and cutting-edge treatment protocols such as transcranial magnetic stimulation, esketamine, and IV Ketamine for patients living with TRD and other serious mental illnesses. MHS operates over 20 outpatient clinics located across California, Washington, Texas, and Georgia.  MHS has a team of psychiatrists, therapists and nurse practitioners focused on helping patients get the help they need. They are dedicated to improving patients’ lives, especially those suffering from depression.