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COMPASS Pathways granted patent covering use of its psilocybin formulation in addressing treatment-resistant depression

LONDONJan. 13, 2020 /PRNewswire/ -- COMPASS Pathways, a mental health care company, announced today that it has been granted US Patent No 10,519,175, relating to methods of treating drug-resistant depression with a psilocybin formulation, by the US Patent and Trademark Office. The patent covers the use of COMPASS's synthesised investigational psilocybin formulation, COMP360, in a psilocybin therapy protocol for patients with treatment-resistant depression. Psilocybin is an active ingredient in so-called 'magic mushrooms'.

Last month, COMPASS reported that COMP360 was well tolerated when administered to healthy adult volunteers with support from specially trained therapists in a randomised placebo-controlled trial. COMPASS is currently running a phase IIb clinical trial of COMP360 in treatment-resistant depression. This trial is recruiting 216 patients from across Europe and North America who suffer with depression that hasn't responded to established medications, and will be the largest clinical trial of a psilocybin formulation to date. In 2018, COMPASS received FDA "Breakthrough Therapy" designation for its programme of psilocybin therapy for treatment-resistant depression.

George Goldsmith, CEO and Co-founder, COMPASS Pathways, said, "Too many people are suffering with treatment resistant depression. We are committed to developing innovations, such as psilocybin therapy, to address this rapidly growing problem. Patents help ensure sustainable funding to conduct the highest quality clinical research to bring the best new therapies to patients who urgently need them. If this research demonstrates psilocybin therapy is a safe and effective option for patients, we will price it responsibly with the goal of making it as affordable and accessible as possible."

COMPASS Pathways and King’s College London announce results from psilocybin study in healthy volunteers

COMPASS Pathways, a mental health care company, has reported that its COMP360 (psilocybin) was well-tolerated when administered to healthy adult volunteers with support from specially trained therapists in a randomised placebo-controlled trial by King's College London. The results from the phase I study, including data on safety and the feasibility of simultaneous 1:1 administration, were presented last night at the annual meeting of the American College of Neuropsychopharmacology (ACNP). Psilocybin is an active ingredient in so-called "magic mushrooms."

The study looked at the effects of 10mg and 25mg doses of COMP360, compared with placebo, in 89 healthy volunteers. Doses were administered simultaneously to up to six participants, who then received 1:1 psychological support from an assisting therapist throughout the session, overseen by a lead therapist and study psychiatrist.

Key results:

  • There were no serious adverse events
  • The majority of adverse events seen with the 10mg and 25mg doses were of the expected psychedelic nature; the most frequent were changes in sensory perception and positive mood alteration
  • COMP360 had no negative effects on cognitive and emotional functioning
  • The study demonstrated the feasibility of administering COMP360 in a controlled setting to healthy participants with 1:1 therapist support, with up to six sessions running simultaneously

In 2018 COMPASS received FDA Breakthrough Therapy designation for its programme of psilocybin therapy in treatment-resistant depression. COMPASS is currently running a phase IIb study across Europe and North America, involving 216 patients who suffer with depression that hasn't responded to established medications.

Dr Ekaterina Malievskaia, Chief Innovation Officer and Co-Founder, COMPASS Pathways, said, "This study is part of our overall clinical development programme in treatment-resistant depression; we wanted to look at the safety and tolerability profile of our psilocybin, and to look at the feasibility of a model where up to six 1:1 sessions are held at the same time. We are focused on getting psilocybin therapy safely to as many patients who would benefit from it as possible. We are grateful to the many pioneering research institutions whose work over the years has helped to demonstrate the potential of psilocybin in medicine."

Dr James Rucker, Consultant Psychiatrist and Senior Clinical Lecturer in Psychopharmacology at King's College London's Institute of Psychiatry, Psychology & Neuroscience, and lead investigator of the study, said, "This is the largest controlled study of psilocybin to date. The results of the study are clinically reassuring and support further development of psilocybin as a treatment for patients with mental health problems that haven't improved with conventional therapy, such as treatment resistant depression."

About this phase I placebo-controlled trial of COMP360 in healthy volunteers:

In this double-blind, placebo-controlled study, 89 healthy volunteers were randomised in a 1:1:1 ratio to receive 10mg COMP360 (n=30), 25mg COMP360 (n=30), or placebo (n=29), with 1:1 support from a trained assisting therapist during a session lasting about six hours. In total, 25 dosing sessions were completed, with up to six participants per session. The study involved a 12 week follow-up period.

COMPASS Pathways News | December 2019 Issue

Dear all

The COMPASS family has grown. Our Christmas party this year was a large, noisy and joyful occasion - and as our team, advisers, partners, investors and supporters chatted, I felt deeply grateful to all of you who have trusted our intentions, vision and skills, were generous with your time and expertise, and joined us as we work to transform mental health care.

As another year comes to an end, I wanted to share my reflections on 2019 at COMPASS.

It feels good to have reported our first clinical data from our healthy volunteers study, at the annual meeting of the ACNP (American College of Neuropsychopharmacology) in December. In addition to creating regulatory quality data on the short- and long-term safety of psilocybin, we explored the safety and feasibility of 1:1 therapeutic support with several simultaneous sessions. If further supported by regulators, this model could expedite research and eventually improve patient access to innovative treatments. The healthy volunteers study was completed in less than a year, an accomplishment made possible by the dedicated team at the Institute of Psychiatry, Psychology & Neuroscience at Kings College London.

James Rucker from IoPPN, presenting at ACNP

Our core clinical program of psilocybin therapy in treatment-resistant depression is progressing well. We now have 18 sites actively recruiting patients, across Europe and North America. In addition, a number of investigator-initiated studies for other indications of significant unmet need have received regulatory approval and will start in 2020. We have learned, and continue to learn, a huge amount about running regulated clinical trials with psychoactive substances. This includes best practice around manufacturing and handling a scheduled substance; therapist training; patient recruitment; and psychological support and care.

It’s not easy for patients with mental illness to demand an increase in research funding and equitable access to mental health care - these patients need advocates. This year we partnered with the US Depression and Bipolar Support Alliance (DBSA), a peer-support advocacy organisation, to better understand the realities and needs of patients living with depression and other mood disorders. It was a highlight of the year for me to participate in a joint meeting of the DBSA and the FDA (US Food and Drug Administration) on patient-preferred outcomes and their role in the regulatory decision process. With the emergence of a new class of psychoactive rapid-acting antidepressants, such as esketamine and psilocybin, established methodology and existing psychiatric scales might not be able to reflect the real value these new treatment paradigms create for patients, families and health systems. To understand this better, we look forward to working closely with regulators, researchers and patient groups on these and similarly challenging questions in the new year.

It’s been a tremendous year for the field of psychedelic science. We have seen psilocybin therapy becoming more widely known and accepted: new psychedelic research centres have been established at Imperial College London and Johns Hopkins University, with combined pledges of over $20m; and new conferences of the International Society of Research in Psychedelics and European MIND Foundation have launched with great success. We were delighted to see that, a year after we received Breakthrough Therapy designation for our psilocybin therapy for treatment-resistant depression, the FDA granted another Breakthrough Therapy designation for psilocybin, this time in major depression to Usona Institute. This highlights the regulatory support for new approaches to caring for patients suffering with depression. Just last month we had a thoughtful and constructive four hour consultation with the European Medicines Agency (EMA) and European payors (EUnetHTA – European Network for Health Technology Assessment) on the evidence required for psilocybin therapy to be reimbursed and integrated into national health systems, so all patients in need can access it regardless of their ability to pay. The outcomes of our conversations with patient advocacy groups, regulators and payors will further inform our clinical development programme for the next few years.

This year we have also witnessed the growth of interest in psilocybin from entrepreneurs and investors. According to LinkedIn, there are now more than 300 new companies and platforms in the psychedelic space, mostly focusing on recreational consumer-oriented markets. As the field grows, the division between recreation and medical use will become clearer as these different models require different resource and funding, skills and risk tolerance. Our business development team has been hard at work, looking at investment and partnership opportunities outside of our current programmes, with a focus on ideas that offer transformative treatments and new models of patient care. The most successful decriminalisation and legalisation efforts are unlikely to make a dent in the mental health crisis we are facing. The research in new therapeutic targets and novel treatments will continue within the constraints of the current regulatory and healthcare systems. For the first time in decades, psychiatry has a real shot at having approved treatments that not only alleviate the symptoms, but empower patients, and we simply cannot afford to miss that chance.

And so to 2020. Next year we aim to complete our phase IIb clinical trial of psilocybin therapy for treatment-resistant depression, and to analyse and report results from over 20 pre-clinical and early phase clinical studies.

Most importantly, we will also focus on developing our strategic academic and business partnerships, and sponsored research, to create clinical research centres with deep experience and understanding of psychedelic science and therapy. I hope that 2020 will be the start of the decade in which we see a real transformation in mental health care and come closer to our vision of a world of mental wellbeing.


COMPASS London team 2019

We wish you and your loved ones all the very best for the holidays and the New Year. As always, please share your reflections, ideas and questions with us.

With warm holiday wishes,

Ekaterina

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