Mental health treatments often fail many patients, leaving them struggling to find relief and support. Patients in this category are often considered “treatment-resistant,” where multiple therapies have limited or no effectiveness. Many people with mental health conditions such as depression, anxiety or bipolar disorder encounter this frustrating reality. Despite their efforts to seek help, they are unable to find effective treatments that alleviate their symptoms and improve their quality of life.

This failure of mental health treatments further exacerbates the marginalization experienced by individuals with these conditions. As their condition persists or worsens, they may face stigmatization, discrimination and isolation. Often, this is because treatment is looking at a singular tool for a heterogeneous or multiple-cause disease state. For example, some drugs on the market currently modulate serotonin, norepinephrine and dopamine transmission within the brain. For some patients, this helps maintain a healthy mental state –  but for others, it not only fails to work but may cause undesirable side effects. 

Geoff Grammer, Chief Medical Officer of Greenbrook NeuroHealth Centers breaks down the current landscape, sharing, “If we think of depression, kind of like headache, there's a lot of things that cause headaches. If you came and saw me for a headache and I said, all I got is Tylenol, that's going to leave you wanting. Take migraines, for example, [Tylenol is not even a suitable drug to administer]. Often people need different classes of agents for that. So what we're beginning to see is people breaking away from that kind of very rigid [historical] model and bringing more tools to the front to give patients more options to try to address some of those variations in what's causing the disease.”

To address these issues, there is a pressing need for not only the development of better treatments but also improved access to them. It is crucial to ensure that individuals with mental health conditions have readily available and affordable access to a range of evidence-based therapies, such as psychotherapy, medication and alternative interventions. One investigational therapy that has emerged in recent years is psilocybin treatment, particularly for illnesses like treatment-resistant depression (TRD) or PTSD.

Steve Levine MD, Senior Vice President of Patient Access and Medical Affairs, COMPASS Pathways, shares, “We need as many tools in the toolbox as possible because the demand is so great in psychiatry.  And we're on the cusp of that, whether it's psychedelic treatments or other promising innovations that we will hopefully see approvals for in the coming years, as well as the infrastructure that's being built to deliver them. In the coming decade, I hope we will see increased access for patients in need of care and better tools to meet those needs coming together to make a difference for these patients.”

The company’s innovative approach has received FDA Breakthrough Therapy designation in the U.S. and Innovative Licensing and Access Pathway designation in the UK for their investigational COMP360 psilocybin in treatment-resistant depression. Moreover, in late 2021, COMPASS Pathways announced the completion of a randomized, controlled double-blind phase 2b study of investigational COMP360 psilocybin treatment involving 233 patients with TRD in 22 sites across Europe and North America.

As part of its goal to develop new and more effective treatment options for TRD and other difficult-to-treat mental health conditions, COMPASS is researching and developing an integrated digital and AI product ecosystem to potentially improve the prediction of patient outcomes, scale therapist training and gain a better understanding of TRD as an illness. While the vision is to use these tools in tandem with COMP360 psilocybin treatment if approved, they are being built with scalability and broad use in mind in order to help impact the treatment of a wide range of mental health disorders. 

Treatment-resistant patients are a high unmet need. There is a need not only for innovative treatments but also for companion technologies and programs to support patients. It is also crucial for psychedelic treatments to go through clinical trials to establish safety and efficacy and through formal FDA approval so patients can get access to care in a regulated medical system. COMPASS Pathways, along with peers like BioRestorative Therapies (NASDAQ:BRTX), are innovators in a growing market.