News of the FDA approval of psilocybin therapy trials had rocked through the mainstream media and underground psychedelic communities alike this summer. The Food and Drug Administration has granted Compass Pathways the license to pursue trials in America that are among the first of their kind. The company has long since gained approval from regulators in the UK, the Netherlands and Canada, and are well underway researching the applications of psilocybin.
Those interested in psilocybin-containing fungi, and the medicinal powers of mushrooms, are all abuzz about the new trials; investors and some big names in science are showing interest and hopping on board. Let’s take a look at the company, who’s involved and what they intend to do in the short-term and long, to increase access to psilocybin and other “unconventional” compounds. If you’d like to read more about the company details, check out our business profile.
Psilocybin as a mental health treatment
In their own words, Compass Pathways seeks to assist in “accelerating patient access to evidence-based innovation in mental health. ” Born in 2016 from the experiences the founders had with current weaknesses in the treatment of mental health, it seeks primarily to develop psilocybin therapy for Treatment-Resistant Depression (TRD). The husband-and-wife co-founders saw no other viable choice after other treatments for their son’s depression had failed.
In the last fifty years, there have been at least 65 clinical trials involving psilocybin, but only a handful of those were rigorous investigations using psilocybin therapy as a mental health treatment. The recent decade has seen a surge of studies, pursued by such prestigious institutions as Johns Hopkins, NYU, UCLA and the Imperial College London.
Primarily investigated as a counter to existential distress in terminal cancer patients, psilocybin has been explored in addiction therapy and as treatment for OCD and TRD. These studies have been relatively limited in scale, usually including less than 50 participants, partly due to a lack of access to purified compound. One of the first goals of Compass Pathways was to produce significant batches of high-grade psilocybin for research purposes.
They have recently produced 500 grams of the purified chemical, equating to nearly 20,000 average doses. It was created using the highest of regulatory standards (cGMP), assisting its application to the FDA and other agencies. While most is being used in stability trials, a requirement for drug testing, the rest has been packaged and is actively being used or distributed to support late-stage clinical trials and independent investigator-led trials at leading academic sites.
Supporting patient access
As a collaborator with independent research, Compass Pathways has been able to distribute free psilocybin to members of the European College of Neuropsychopharmacology through its Medicines Chest Program. The company is actively seeking ways to expand this distribution network and provides low-cost psilocybin to those outside current programs. Further, they provide assistance in developing protocols and clinical trials to maintain rigorous investigation and reporting.
This high scientific standard has been made a hallmark of the Compass Pathways process. They have vowed to publish all results of their internal trials, both positive and negative outcomes, in the fastest ways possible. On top of supporting independent and translational research, focus and effort persists into accelerating regulatory processes and increasing patient access.
To this end, they are also investigating other indications for psilocybin therapy, in addition to TRD. Further, they hint toward the development of up to two “new” substances, with a goal of taking them to market within the next decade. On top of these pursuits, here are a sample of their current activities involving psilocybin:
A Clinical Trial on Treatment-Resistant Depression (TRD)
- Taking place in Europe and North America (This is the important FDA approval)
- Not necessarily a new investigation, but much larger sample size
- This is considered a phase 2B trial, with ranging dosage
- 216 participants over 12 to 15 different testing sites
Already underway in the United Kingdom (London, Manchester, Newcastle)
- Two other sites in the Netherlands (Groningen, Utrecht)
- Working with “Worldwide Clinical Trials”
- Upon success, will be followed by a phase 3 trial
- Investigates optimal dose and standards of care
A Healthy Volunteer Study on Cognition and Emotional Processing
- A phase 1 trial, double-blind
- 90 participants, aged 18-65
- Dosed 10 or 25 mg of psilocybin, or placebo
- Simultaneous dosing of 6 people (group interaction)
- Tested over 12 weeks with 4 check-ins
IoPPN, King’s College London; U. of Zurich, Switzerland
- In association with Cambridge Cognition
- Began mid-summer 2018, expected to finish mid-November 2018
- Results by early 2019
To facilitate and improve studies like these and those in the future, Compass Pathways has established partnerships that provide innovative training and tracking features. Mindstrong Health monitors “digital biomarkers of brain health” by using smartphone interactions to examine mood and emotional state. Calm is an application that assists therapists in meditation training and provides relevant content. 7Cups is yet another tool for therapists and clinical trial operators that develops active listening skills.
Collaborations like these are a central pillar of the Compass Pathways sustainable business model. In an effort to best deliver novel therapies and enable patient access, they have settled on a “balanced for-profit model” of operation. They hope this will incentivize innovation by “exercising of intellectual property rights” and being “open to flexible, value-driven approaches to pricing.” In short, they seek to generate a “reasonable profit” from various applications in the hope that it will drive interest and funding for their primary goal of psilocybin therapy.
Psilocybin therapy, and psychedelic therapy in general, has generally been seen as an esoteric or “future” treatment for any mental disorder. Compass Pathways seems poised to fast-track at least one application of the purified compound, tackling treatment-resistant depression, opening the door to many other applications and chemicals.
Stay tuned for exciting developments coming from this venture and others that are similar. Already, other businesses are cropping up; the next “Business Spotlight” will focus on Atai Life Sciences, a company helmed by Christian Angermayer that has already raised $25 million to continue funding work with psychedelic therapies. And don’t forget to look at our full business profile breakdown on Compass Pathways.