atai Life Sciences (NASDAQ: ATAI), the innovative mental health platform company I have started in 2018, of which I am Chairman and which is committed to unlocking the compelling potential of psychedelics, has announced this morning that it has bought an additional stake in COMPASS Pathways (NASDAQ: CMPS), bringing atai’s ownership in Compass beyond 20%.

Here are some of our reasons and considerations:

COMPASS Phase 2b results for TRD have been excellent

We think the COMPASS Phase 2b trial for Treatment-Resistant Depression (TRD) is a total game-changer. COMPASS had the tenacity to stage the world’s largest psilocybin (the active ingredient in so called “magic mushrooms”) trial to date – through the pandemic! – and their COMP360 psilocybin candidate has delivered, showing real and meaningful potential in tackling TRD – a major mental health challenge.

Treatment-resistant depression – meaning patients have tried everything possible and did not find relief – is a harrowing condition affecting one in three people with depression – that’s a staggering one hundred million people worldwide for whom current depression treatments just don’t work.

In this trial, many patients found rapid relief after just ONE single dose of COMPASS’s psilocybin. We believe that this is an incredible result with important implications for the future of mental health care.

We believe that the game-changing nature of the trial has not yet been fully realized by the broader market. atai is taking advantage of this mis-pricing opportunity and has increased its strategic investment into COMPASS.

The details of the trial show the potential of Psilocybin

Just one 25mg dose of psilocybin reduced patients’ depression by 6.6 MADRS points from baseline to week three (vs. 1mg), meeting the primary endpoint of the trial. The MADRS (Montgomery–Åsberg Depression Rating Scale) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. This, to our knowledge, is the largest antidepressant effect demonstrated in such a short period.

To put this into context, most standard selective serotonin reuptake inhibitor (SSRI) antidepressants are approved on the basis of just a 2-3 point reduction and can take many weeks to take effect, while intranasal esketamine demonstrated just a 4 MADRS point reduction at 28 days in TRD (in third party studies).

The potential real-life impact – keeping in mind that these data were generated under stringent clinical trial conditions and without any tailoring to the specific needs of the individual – could be even more transformative for those patients suffering from TRD.

TRD is just the beginning

And it’s important to remember that treatment-resistant depression is just the beginning here. COMPASS already is exploring the potential of COMP360 across many more mental health conditions, or conditions wherein mental health is compromised. It has trials underway in depression in cancer and post-traumatic stress disorder, and is exploring numerous other potential indications including, anorexia nervosa, body dysmorphia, type 2 bipolar disorder depression, suicidal ideation, autism, with many more to come.

Additionally important to know: COMPASS has both – patent protection on their synthetic psilocybin as well as anticipated data exclusivity – often equally important and powerful as patents – on the indications mentioned above and more. Patents and intellectual property (IP) are IMO the most important pillar of drug development, and psychedelic drugs are no exception. Patents foster innovation, and innovation benefits patients in need.

IMO in the long term the only thing that matters is delivering robust evidence in rigorous scientific approval trials, combined with patent protection to be able to fund these trials and pay investors adequate returns. All with the goal that patients can have access to the valuable compounds as soon as possible. The companies that will thrive are those that are able to deliver, and we believe COMPASS has impressively proven it has the ability to do just that.

And being confident all along about the results for their phase 2b trial, COMPASS management has shown conviction and already prepared everything for their phase 3 study of psilocybin in TRD, which is anticipated to launch in 2022.

atai is committed to leading this new field of mental health innovation

Our increased ownership of COMPASS Pathways is a demonstration of our strong, ongoing confidence in the potential of psilocybin, in the management team of Compass and in the future of COMPASS Pathways as a ground-breaking pioneer in mental health.

We see their great progress with psilocybin as highly complementary to our wider mental health innovation work at atai, spanning psychedelics, non-psychedelics and digital therapeutics.

In addition to our stake in COMPASS, atai has 11 (!) more clinical programs underway, focused on a broad range of mental health issues, including two compounds which are also already in Phase 2 and hence right in the heels to Compass: R-Ketamine in Treatment-Resistant Depression and RL-007 against Cognitive Impairment Associated with Schizophrenia – with Phase 2a data expected in late 2021.

We are proud to now play an even bigger part in COMPASS’ future and look forward to all we may achieve together, all in line with our vision, at atai, to heal mental health disorders, so that everyone everywhere can live a more fulfilled life.