COMPASS Pathways: Leading the Mental Health Care Evolution

“At COMPASS, our vision is a world of mental wellbeing. Every one of us is committed to discovering and developing new therapies that will help patients and their families. For too many people, mental health care today isn’t good enough. We are determined to change that.”

– COMPASS, “Why we exist”.

 

COMPASS Pathways (CMPS) describe themselves as “a mental health care company.” Perusing the company website, there are continued references to concepts such as building the “mental health care ecosystem of the future”, and “accelerating patient access to evidence-based innovation in mental health .”

The current status of mental health care in the United States, and worldwide, is…less than ideal:

• Suicide is the 4th-leading cause of death in persons age 15 – 29 years

• An estimated 10% – 30% of patients with depression do not respond to “typical” antidepressant medications, such as SSRIs.

• One estimate posits that 50% – 66% of patients with depression taking a typical antidepressant medication alone report less than “full” efficacy – in other words, the antidepressant kind of sort of works but the patient still feels some level of clinical depression.

• Depression and anxiety alone cost the global economy $1 trillion ANNUALLY due to lost productivity. And, evidence suggests that depression remains underdiagnosed and undertreated across health systems across the globe.

COMPASS describes themselves as a mental health care company, perhaps because they see a role for the company beyond psychedelics. Currently, though, their big project is COMP360 – a proprietary psilocybin formulation developed by COMPASS that is currently undergoing pivotal phase 3 trials to evaluate its use for treatment-resistant depression (TRD). COMP360 is also under study for treating other conditions as well.

This article hits on some recent updates from COMPASS which give us hints and insight into their pipeline, development process, and when we can anticipate psilocybin therapies reaching patients.

Recent Updates on COMPASS

There are several recent updates from COMPASS to discuss.

$286 Million Fundraising Round

COMPASS secured $286 million across 11 investment firms (led by TCGX and Aisling Capital) in a private fundraising round, the company recently announced in August 2023. The company expects the funds to cover financial needs through “late 2025”.

This follows a previous $50 million in debt financing secured from Hercules Capital Inc earlier this year.

This funding may be a sign COMPASS is very confident that their psilocybin product, COMP360, will receive FDA-approval – and have the data and plan to instill confidence in investors as well.

COMP360

COMP360 is COMPASS’s synthetic psilocybin formulation. A Phase 3 trial evaluating COMP360’s efficacy for treatment-resistant depression is currently recruiting patients. COMP360 has received a “Breakthrough Therapy” designation from the Food and Drug Administration (FDA). This designation is reserved for potential therapies which treat a serious condition, and for which early clinical evidence suggests the therapy offers substantial improvement in treating the condition compared to currently available therapies.

COMP360 is also under study for treating conditions besides treatment-resistant depression. Currently, there are Phase 2 trials looking at whether COMP360 is effective as a treatment for post-traumatic stress disorder (PTSD), as well as anorexia nervosa.

Projecting 2027 for Commercialization of Psilocybin Therapy

In July 2023, COMPASS participated in the Psych Global Symposium, hosted in London, England. (COMPASS is headquartered in London.) During the event, the company made predictions regarding commercialization of psilocybin therapy. This makes sense – COMPASS is currently well positioned to know when psilocybin products may reach patients.

COMPASS is currently running two phase 3 trials for their proprietary psilocybin formulation, COMP360, for use in patients with treatment-resistant depression (TRD). COMPASS describes the trial as “the largest randomized, controlled, double-blind psilocybin treatment clinical program” to date.

At the symposium, representatives for COMPASS commented that they are expecting results from the first trial around mid-2024. We’ll have to wait until 2025 for results from the second trial. If results from these trials meet the threshold for achieving their intended outcomes, COMPASS states commercialization of COMP360 may happen “by the beginning of 2027”.

Important to note – it’s not clear whether COMPASS was referencing approval by the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA) with respect to the 2027 prediction.

Or maybe it’s both?

Conclusion

COMPASS is currently focused on COMP360 and evaluating its use across several mental health conditions. They recently closed a funding round which secured $286 million in funding, which should carry the company through completion of Phase 3 trials for COMP360 in treatment-resistant depression.

Perhaps more interesting – or maybe it’s just me – will be watching to see what non-COMP360 products COMPASS brings to the table. If COMP360 receives approval and is a financial blockbuster, this could fund further research into other proprietary psychedelic molecules – a different version of MDMA, DMT, or ketamine, for example.

I’ll avoid making another horrible COMPASS pun and simply leave on this note – COMPASS has been in the psychedelic game since the wave hit in the 2010s. I don’t think they’re going away anytime soon.

If they weren’t previously on your radar, today’s article hopefully showed why they should be.