Compass Pathways
COMP360 is the company’s proprietary, synthesized formulation of psilocybin, currently under investigation as a potential treatment for difficult-to-treat mental health conditions, most notably treatment-resistant depression (TRD).
DRUG PROGRAMS TARGET: Treatment-resistant depression,anorexia nervosa and PTSD.
SUBSTANCE FOCUS: Psilocybin.
CLINICAL TRIALS: Yes.
NEWS & PARTNERSHIPS:
2022
The company presented positive data from the largest randomized, placebo-controlled, double-blind study of psilocybin therapy ever completed, at the American Psychiatric Association annual meeting in New Orleans. The study showed that a single 25mg dose of COMP360 psilocybin, in combination with psychological support, was associated with a highly statistically significant reduction in depressive symptoms after three weeks (p<0.001), with a rapid and durable response for up to 12 weeks. The study will investigate whether there is a difference in the function of serotonin brain networks in autistic and non-autistic adults. The researchers will use a range of imaging techniques and behavioral tasks to examine how the serotonin system is modulated by COMP360 psilocybin. It is an investigator-initiated exploratory study that will take place at the Institute of Psychiatry, Psychology & Neuroscience at King’s College London. The study is co-sponsored by King’s IoPPN and South London and Maudsley NHS Foundation Trust. It will enroll 70 adult participants, including 40 autistic people and 30 non-autistic people.
The company partnered with One Mind to fund Rising Star Awards for the next generation of mental health researchers. The winners will each receive a 300,000 USD research grant sponsored by COMPASS over 3 years. They will also be eligible to participate in select leadership development and entrepreneurship opportunities through the One Mind Rising Star Development Program offered by One Mind.
The company formed a long-term strategic partnership with South London and Maudsley NHS Foundation Trust to launch The Centre for Mental Health Research and Innovation to accelerate psychedelic research and develop new models of care for mental health in the UK. The collaboration will provide patient access to cutting-edge research studies in multiple areas of high unmet need in mental health. The Centre will accelerate research of emerging psychedelic therapies, support therapist training and certification, evaluate real-world evidence, and prototype digital technologies to enable personalized, predictive and preventative care models. Research will initially focus on the company’s investigational COMP360 psilocybin therapy and supportive technologies and will also cover other novel therapeutic approaches being researched and developed by COMPASS, in areas of significant unmet mental health need including TRD, PTSD and anorexia nervosa.
2023
The US Patent and Trademark Office rejected requests for rehearing of the USPTO’s decision denying institution of post-grant review of US patents 10,947,257 and 10,954,259.
The company and MAPS Public Benefit Corporation announced that the American Medical Association approved a current procedural terminology III code for psychedelic therapies. Once effective, the CPT code will provide physicians and other qualified healthcare professionals a means to code and seek reimbursement for delivering psychedelic therapies.
2024
The company entered a research collaboration with Mindful Health Solutions to inform the development of a scalable and cost-effective delivery model for investigational COMP360 psilocybin treatments.
The company entered a research collaboration with Mindful Health Solutions to inform the development of a scalable and cost-effective delivery model for investigational COMP360 psilocybin treatment. The collaboration 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.
The company entered into a 3-year research collaboration agreement to explore delivery models for investigational COMP360 psilocybin treatment. The collaboration will research and investigate models for the delivery of scalable, commercial COMP360 within healthcare systems. The initial phase of the collaboration will comprise research into the delivery of COMP360 at treatment centers across the United States, such as through Greenbrook TMS’s current network of treatment centers, working with their patient populations, which include people suffering with treatment-resistant depression (TRD) and other mental health conditions. In-depth research will include exploring how to improve the patient care experience and gaining a better understanding of therapist needs and investigating the potential use and integration of digital tools within Greenbrook TMS’s existing care pathways.
The company entered into a research collaboration agreement with Journey Clinical to inform the development of a scalable and practical delivery and healthcare provider training model for COMP360 psilocybin treatment. The first phase of the collaboration comprises an in-depth information exchange on the COMP360 psilocybin treatment delivery model. Together, Compass and Journey Clinical will work to better understand the patient care experience, depression patient pathways and care reimbursement processes, and explore innovative care pathways for TRD patients. They will conduct research into therapist training, support, and education, and exchange information on treatment settings for psychedelic therapies. Journey Clinical has built the necessary infrastructure to support broad access to new psychedelic treatments for mental health conditions. Their collaborative care model connects a dedicated medical team, licensed psychotherapists, and patients, supporting the delivery of psychedelic treatments responsibly and at scale, starting with ketamine-assisted psychotherapy. They have a network of over 2,000 therapists, an in-house model of therapist peer support and mentorship, and are partnered with leading therapist training providers.
The company entered into a research collaboration agreement with Hackensack Meridian Health to inform the delivery model design of investigational COMP360 psilocybin treatment. The collaboration between Compass and HMH aims to improve health outcomes and improve patient and provider experiences for mental health conditions such as treatment-resistant depression. Together they will work to understand the real-world challenges and opportunities of delivering care to those living with depression, to inform how future clinical trials of COMP360 psilocybin treatment are designed, and to understand how it will be delivered to patients, if approved.
2025
The company started trading on the NASDAQ Biotechnology Index.
The company has entered a strategic collaboration with the community health organization HealthPort to explore the potential delivery of its investigational COMP360 synthesized psilocybin treatment within underserved populations, contingent upon future FDA approval. By focusing on the unique challenges faced by patients in these settings, the partnership aims to identify and address systemic barriers to equitable access while researching operational frameworks for therapist training, care reimbursement, and the integration of psilocybin therapy into existing community mental health models.
2026
The company started a strategic collaboration with Radial Health, a national network of interventional psychiatry clinics, to design scalable delivery models for its investigational COMP360 psilocybin treatment, contingent upon future FDA approval. By leveraging Radial’s expertise in building customer-centric, operationally scalable healthcare systems, the partnership aims to develop and refine the integration of COMP360 into clinic workflows to ensure a seamless patient experience upon potential market launch.
The company announced a US grant program inviting qualified organizations to develop specialized training content for healthcare providers regarding the delivery of its investigational COMP360 psilocybin treatment, contingent upon future approval. By awarding grants to up to three organizations, the company aims to leverage existing expertise in psychedelic care to build robust, COMP360-specific modules that ensure providers are well-prepared to deliver high-quality, consistent patient care at scale upon an expected commercial launch.
The company entered into a collaboration with Osmind, a platform supporting a large network of interventional psychiatry practices, to help small-to-medium-sized clinics prepare for the potential delivery of its investigational COMP360 psilocybin treatment, contingent upon FDA approval. By leveraging Osmind’s technology and services, the company aims to better understand the operational, clinical, and infrastructure needs of independent psychiatry practices to develop scalable, real-world care models that ensure patient safety and clinical excellence upon a potential future launch.
The company was granted a rolling review for its New Drug Application by the FDA and has been awarded a Commissioner’s National Priority Voucher for its investigational COMP360 synthetic psilocybin treatment for treatment-resistant depression. These regulatory milestones, supported by positive data from two large-scale Phase 3 trials, entitle the company to enhanced communication and significantly accelerated review timelines, potentially reducing the standard review process to one or two months while maintaining the agency’s rigorous safety and efficacy standards.