News & views

Our collective understanding of mental health is increasing all the time, with advances in neuroscience, psychotherapy, psychopharmacology and digital platforms.

Latest COMPASS news

COMPASS Pathways receives FDA approval for psilocybin therapy clinical trial for treatment-resistant depression

For online press release, see: https://www.prnewswire.com/news-releases/compass-pathways-receives-fda-approval-for-psilocybin-therapy-clinical-trial-for-treatment-resistant-depression-868824616.html

COMPASS Pathways, a life sciences company dedicated to accelerating patient access to evidence-based innovation in mental health, has received approval from the US Food and Drug Administration (FDA) for a clinical trial in psilocybin therapy for treatment-resistant depression. Regulatory approvals for the trial have already been given in the UK, the Netherlands and Canada.

The trial is a phase IIb dose-ranging study with 216 patients taking part in 12 to 15 research sites across Europe and North America. It will begin in the UK later this month and sites in other countries will join the trial as further regulatory approvals are received.

Psilocybin therapy combines a dose of psilocybin (a psychoactive medicine and the active ingredient in “magic mushrooms”) with psychological support, and has shown promising signals of efficacy and safety as treatment for depression in academic studies in the UK and US. If the trial is successful, it will be followed by phase III studies.

George Goldsmith, Chairman and Co-founder of COMPASS Pathways, said, “We are excited to be starting this landmark trial which has the potential to transform lives. Depression is the leading cause of ill-health and disability worldwide, and treatment-resistant depression affects more than 100 million people. It is a huge unmet need and the trial will teach us more about how this new approach might address it.”

Ekaterina Malievskaia, Chief Medical Officer and Co-founder of COMPASS, said: “The design of this study has been a truly collaborative effort, with scientists, clinicians, patient representatives and regulators from Europe and North America working together with the goal of helping patients suffering with treatment-resistant depression.“

About COMPASS Pathways

COMPASS Pathways is a life sciences company, founded in 2016 to accelerate patient access to evidence-based innovation in mental health. We are developing psilocybin therapy through a late-stage clinical trial in Europe and North America for patients with treatment-resistant depression. We will improve mental health through the development of new patient care pathways, based on advances in neuroscience, psychotherapy, psychopharmacology, and technology. www.compasspathways.com

Enquiries:

Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Chris Strutt, chris@compasspathways.com, +44 7850 546135

COMPASS Pathways News | July 2018 Issue

This is the second of regular newsletters from COMPASS, highlighting recent and forthcoming events and developments that are relevant to us, our partners and healthcare system stakeholders.

It has been an incredibly busy time since the start of 2018. We are excited by the progress we have made across various areas, all of which promise benefits and hope for patients and their families. We have advanced our plans and preparations for our clinical trial on psilocybin therapy for treatment-resistant depression (TRD); and completed pre-clinical studies, which have provided compelling evidence on the safety of psilocybin therapy in animals and in-vitro models.

In addition, we have manufactured two batches of psilocybin, the equivalent of more than 20,000 doses of 25mg, to cGMP (Current Good Manufacturing Practice) standards to support regulatory assessments and our late-stage clinical trials; we are launching a psilocybin therapy study for healthy volunteers; and we have expanded our team and our board of directors.

About 100 million people suffer with TRD, and do not respond to existing treatments. In addition to the distress and suffering caused for individuals and their families, depression presents a severe cost burden for healthcare systems. Over the next few months, we will begin our TRD clinical trial in Europe and North America.

We’re building on the significant work that has already been done in this area, by gathering evidence in a larger population to see whether psilocybin therapy could provide a breakthrough to help patients suffering with TRD. If it does, we are committed to making sure as many patients as possible will benefit from the treatment.

In everything we do, we are guided by principles that put the patient first. They focus on delivering innovation and providing access to it, adhering to the highest standards of scientific rigour and integrity, and embracing openness and collaboration.

Our clinical trial on treatment-resistant depression

This trial will be a phase IIB dose-ranging study with 216 patients. The first patient will enter the trial in July or August in the UK. The trial will take place in 12 to 15 research sites across Europe and North America. If the trial is successful, it will be followed by phase III studies. Most likely these will compare the optimal dose to either placebo or standard of care.

Earlier this month, we held our first investigator and therapist training meeting at The Champalimaud Centre for the Unknown in Lisbon. This brought together more than 100 people from across Europe, who will be involved in managing the trial and working with patients. Over five days, the clinical teams reviewed the programme and protocol design, discussed recruitment and retention strategies, and received in-depth training to enable them to conduct the study to the highest levels of quality and consistency across research sites. Our clinical research partner, Worldwide Clinical Trials, was impressed by the unprecedented level of participation and commitment of the study teams. In his opening remarks, their president, Angelico Carta, described our partnership as “COMPASSion Worldwide”. We are excited to be working with Worldwide to bring this vision to life for patients.

Healthy volunteers study at Institute of Psychiatry, Psychology and Neuroscience (IoPPN)

In July, we are launching a study of the “Effects of psilocybin on cognition and emotional processing” at the IoPPN, King’s College London, in partnership with the University of Zurich, Switzerland and Cambridge Cognition. Ninety healthy volunteers will be randomised to receive placebo, 10mg or 25mg of psilocybin, administered simultaneously in up to six participants. The study will explore the effects of psilocybin on cognitive and emotional empathy, executive function, memory, attention and cognitive flexibility. In addition to scientific insights, it will provide a unique opportunity for therapists involved in psilocybin research to support psilocybin sessions alongside some of the most experienced researchers and clinicians from the US, UK and Switzerland. The study will run for 16 weeks from 23rd July.

Manufacture of cGMP psilocybin

Through a great collaboration with our manufacturing and formulation partners, we have manufactured two 250g batches of psilocybin, the equivalent of 20,000 doses of 25mg, to the highest regulatory standards (cGMP – Current Good Manufacturing Practice). A large portion of this material is being used for stability testing to meet regulatory requirements. The remainder is now encapsulated, packaged and ready to be shipped to our trial sites. This will support our late-stage clinical trials in Europe and North America as well as independent investigator-led trials at leading academic sites on both continents.

Supporting independent psilocybin research

We are passionate about increasing access to treatments and options for patients, and furthering research that will improve mental health outcomes. So in addition to using our psilocybin for our own clinical trials, we are also making it available, free of charge, to members of the European College of Neuropsychopharmacology (ECNP) through its Medicines Chest programme. We are looking at extending this approach to other eligible scientific associations and researchers with approved protocols.

Psychedelic research in the news

There has been a real surge of interest in the potential of psychoactive medicines in recent months.

Two of COMPASS’s founders, George Goldsmith and Ekaterina Malievskaia, were guests on Rob Reid’s After On podcast and talked about their backgrounds and motivations, and the forthcoming treatment-resistant depression clinical trial.

Significant coverage has also been generated by a new book by Michael Pollan: “How to change your mind – what the new science of psychedelics teaches us about consciousness, dying, addiction, depression and transcendence.” COMPASS and our work is referenced in this book, as well as in an article Michael wrote for the New York Times Magazine in mid-May.

As a result, we are receiving numerous emails from patients and their families from all over the world. These messages inspire us to do all we can to develop and deliver accessible new treatment options for patients who are not helped by current medicines and therapies.

The importance of a sustainable business model

COMPASS is committed to accelerating patient access to evidence-based innovation in mental health. We want to develop and deliver medicines and therapies that can address significant unmet medical need (eg treatment-resistant depression) and then make sure they reach the patients who need them.

That is why we have decided to adopt a sustainable business model, in which we generate a reasonable profit to support and incentivise innovation. This strategy is already yielding important support for our research. For example, we have received our first R&D incentive payment from the UK government. As a private sector business, and based on our R&D investments, we will continue to receive these incentives which will enable us to fund more research. This virtuous cycle will encourage further private sector innovation in life sciences.

Drug development is a complex and costly process, particularly when it involves managing clinical trials and regulatory processes in multiple countries. We believe a balanced for-profit model, which aspires to deliver innovative therapies and enable patient access to them, is most likely to deliver the needed innovation on a long-term basis, which is critical to patients.

Our board of directors and scientific advisory board members

Our expanded board of directors has had its first meeting. Christian Angermayer, George Goldsmith and Ekaterina Malievskaia have been joined by three new independent directors. We welcome Annalisa Jenkins, who brings a tremendous amount of R&D expertise, having served as the Chief Medical Officer at Bristol Meyers Squibb and Head of R&D at Merck Serono; Thomas Lönngren who brings deep regulatory expertise, having led the European Medicines Agency for a decade; and David Norton who brings significant industry experience as former Company Group Chairman at Johnson & Johnson Pharmaceuticals and service on a number of boards.

We are also launching our scientific advisory board with leaders in neuroscience, psychiatry, regulatory science and health systems. They will be overseeing COMPASS's scientific research and clinical development programme to ensure we address the highest areas of unmet need with rigour and clinical equipoise. The members of the advisory board are:

Professor David Nutt MD PhD (Chairman)

  • Edmond J Safra Chair in Neuropsychopharmacology, Imperial College London
  • President, The European Brain Council
  • Former President of the European College of Neuropsychopharmacology

Professor Dr Elisabeth Binder

  • Director, Department of Translational Research of the Max Planck Institute of Psychiatry
  • Associate Professor in the Department of Psychiatry and Behavioral Sciences at Emory University School of Medicine
  • Member, Board of Directors of the European College of Neuropsychopharmacology

Professor Sir Alasdair Breckenridge CBE FRSE

  • Former Chairman, UK Medicines & Healthcare products Regulatory Agency
  • Chairman, Centre of Regulatory Excellence Advisory Board

Thomas Insel MD

  • President & Co-Founder, Mindstrong Health
  • Former Lead, Verily Mental Health team
  • Former Director, US National Institute of Mental Health

Professor Zach Mainen PhD

  • Director of Neuroscience Programme, Champalimaud Centre for the Unknown
  • Leader of Systems Neuroscience Lab and founding director of International Neuroscience Doctoral Programme

Professor Luca Pani MD

  • Executive Director of Global Medical Innovation, NeuroCog
  • Former Director General, Italian Medicines Agency (AIFA)

Professor Diego Pizzagalli PhD

  • Director, Center for Depression, Anxiety and Stress Research; McLean Imaging Center; Laboratory for Affective and Translational Neuroscience
  • Professor in Department of Psychiatry, Harvard Medical School

Professor John Rush MD

  • Professor Emeritus, University of Texas Southwestern MC & Duke-NUS Graduate Med School
  • Recipient of Thomson Reuters: World’s Most Influential Scientific Minds (2014)
  • American Psychiatric Association: Award for Research in Psychiatry (2007)

Professor Paul Summergrad MD

  • Dr. Frances S Arkin Professor and Chairman of Psychiatry Department, Tufts University School of Medicine
  • Past President, American Psychiatric Association

Your feedback

If you’d like to know more about what we are doing or have comments about COMPASS Pathways News, please get in touch with us at info@compasspathways.com. If you’d like to subscribe to our mailing list, you can do here any time.

Welcome to Summer Interns

Summer is here and COMPASS Pathways is thrilled to welcome new interns to the team!  We were impressed with the experience and skills of our summer applicants. After multiple rounds of interviews, five additions were made to our team. Our interns are part of the inaugural class of our internship program. They have come from multiple universities and corners of the world, and we are excited to work with each of them! They are contributing to our activities in various functions including in marketing, research, and clinical trials operations.

Each brings their own unique skill set, and we can’t wait for them to add to our company’s success! Learn a little more about our interns below:

 

              Anais Soula                  

       

Hometown: Anglet, France
Favourite Food: Her grandmother's home cooked food
PhD in Neuroscience: Bordeaux University
MA in Cellular and Molecular Biology: Bordeaux University
MA in Technology and Innovation Management: Paris-Sud University

 

 

 

 

             Claudia Sisa

 

Hometown: Pesaro, Italy
Favourite Food: Margarita Pizza
PhD in Neuroscience of Women's Health: UCL
MA in Biomedical and Neuromotor Science: University of Bologna
MA in Molecular Cellular and Developmental Biology: UCLA

 

 

 

                 

    Nour Awad 

 

Hometown: Beirut, Lebanon
Favourite Food: Japanese
Associate Consultant at ZS Associates
Research Analyst at UNDP
MS in Environmental Health Engineering: Columbia University
BEng in Chemical Engineering: American University of Beirut
BSc in Chemical Engineering: McGill University

 

 

 

                Livia Ng

 

Hometown : Hong Kong
Favourite Food : Scotch Eggs
BSc in Neuroscience: UCL

 

 

 

 

 

          Johanna Fisher

 

Hometown : Villemoiron-en-Othe, France
Favourite Food : Cookies
Franklin Roesevelt Lycee

 

 

COMPASS Pathways News | December 2017 Issue

END OF YEAR UPDATE

December 2017

Dear friends, supporters and colleagues,

The holiday season is approaching, and as we begin dreaming of festive treats and spending the holidays cocooned in thick duvets with a cup of hot chocolate in hand, I would like to reflect on our journey this past year and share a few 2017 highlights.

Trial designed by multidisciplinary team

In February, we held our treatment-resistant depression (TRD) trial design meeting at London’s Home House, assembling experts and leaders from the fields of psychiatry, pharma development, neuroscience and psychedelics. Those of you who were there will remember the spirit of collaboration and mutual learning, and how energised we all were by the novelty and promise of the approach.

EMA scientific advice completed

Only a few months later we presented our trial design and clinical development programme to the European Medicines Agency (EMA), at a scientific advice meeting led by the head Italian regulator and psychiatrist, Professor Luca Pani. We were impressed by how deeply European regulators were thinking about our proposed approach, and how well informed they were about these old, yet new compounds. The EMA’s thoughtful feedback and questions, on topics ranging from pre-clinical data to post-regulatory approval scenarios, led us to revise our protocol and clinical development plan and to develop strategies that will ensure our trial demonstrates safety and efficacy.

Clinical trial programme started

Our clinical trial programme is led by Sue Stansfield, a former global executive at inVentiv Health. Early in her career, Sue completed her PhD focusing on serotonin, and one of her first research projects was conducted in collaboration with Prof David Nutt. We have a strong partner in Worldwide Clinical Trials, our contract research organisation. Worldwide was selected for its commitment to innovation and focus on Central Nervous System (CNS) research. In our first six months of working together, the Worldwide team have demonstrated exceptional engagement, flexibility and resourcefulness. Together we have completed regulatory and ethics submissions in five countries, and have received positive initial feedback from ethics committees and health ministries. We are particularly excited that we have had our first clinical trial approvals, from the UK’s Medicines and Healthcare Products Regulatory Authority and the Dutch Ministry of Health. Well done and thank you to everyone involved!

Trial sites selected

In June we began to look for potential trial sites. We were encouraged by the wealth of psilocybin research knowledge that exists in some of the oldest and most established academic institutions in Europe, and among many of the most reputable researchers and clinicians in the field of mood disorders. Twelve sites in the UK, Norway, Finland, the Netherlands, Germany, Portugal, Spain and the Czech Republic have now been selected. We are delighted that Professor Guy Goodwin, former head of Psychiatry at Oxford University and former president of the European College of Neuropsychopharmacology, has agreed to be a coordinating Principal Investigator of our trial. Our COMPASS/Worldwide team has visited all the sites - a definite highlight of the last six months. To all the Principal Investigators and their teams, thank you for your enthusiasm and determination to overcome any and all challenges!

Patient experience at the core of our trial

We have been developing innovative patient preparation and therapist training models, essential components that will help to ensure the safety and success of the study. With considerable input and guidance from Bill Richards, Torsten Passie, Peter Gasser, and the excellent team at MAPS (Multidisciplinary Association for Psychedelic Studies), we are finalising the structure of the therapist training process for the first group of European therapists. This will use a web-based training platform, followed by three days of in-person training, and an apprenticeship with experienced psilocybin therapists at three European academic sites. We are fortunate to be working with two technology partners who share our vision. Longboat specialises in digital support for clinical trials, optimizing the flow of information between patents and study teams, and improving patients’ experience of research participation. Longboat will be hosting our digital patient preparation platform, showing animations and videos about psilocybin. Another partner, Mindstrong, will be collecting behavioural markers of depressive symptoms via a mobile application, with the ultimate goal of personalised care for depression.

cGMP (Good Manufacturing Practices) psilocybin now available for research

This year, we have completed synthesis, formulation, stability testing, and all pre-clinical tests for psilocybin. Our psilocybin has made the transition from a research chemical to a medicinal product, ready to be approved upon successful completion of phase 2b/3 trials in the EU and US.

The availability of cGMP-grade psilocybin has stimulated a lot of interest in the scientific community. COMPASS will provide psilocybin for investigator-initiated studies in at least nine countries across Europe, North America and Australia for psychiatric and medical indications, as well as experimental studies, free of charge. All participating sites will be contributing to the unified safety database which will help expedite approval and, ultimately, patient access.

Team growth

In addition to Sue Stansfeld, we have been joined by two new colleagues: John Boghossian, who is leading business and partnerships development, and Molly Lennard-Jones, our team coordinator. John graduated from MIT and the Harvard Business School and comes with experience in market access. Molly developed a strong interest in mental health after completing her research thesis on the role of personal narrative in PTSD among Holocaust survivors. Since September we have also been working with Chris Strutt and Tracy Cheung, formerly of GlaxoSmithKline and GE Healthcare respectively, who support us on public affairs and communications. We are fortunate to have such a talented and experienced group of people in the COMPASS team and our rate of progress has increased rapidly since they have been on board.

We have welcomed two new members to our advisory board: Dr Tom Insel, a neuroscientist and former head of the US National Institute of Mental Health; and Dr Paul Summergrad, the head of Psychiatry at Tufts University Medical School and former head of the American Psychiatric Association. We are deeply grateful to all of them and our ‘founding’ advisors - including Prof Sir Alasdair Breckenridge and Dr John Rush - for their continued support, expertise and wisdom.

Lastly, I want to express my thanks to two people without whom COMPASS would still have been a dream: Joe Heinen, our Chief Financial Officer, and Sarah Drummond, who makes all the important conversations and events happen.

Looking ahead

It has been a very busy year and 2018 is set to continue in the same way. A few key events:

With all the positive signals following our regulatory submissions, we are well positioned to enrol our first patient in March 2018. We expect to complete the enrolment for the dose finding phase of the study by the end of 2018.

A study of 50+ healthy volunteers is planned for Q2 2018. This study will explore the safety and effects of psilocybin on cognitive function and emotional processing. It will also begin to collect safety data on the simultaneous administration of psilocybin in groups of 5-10 volunteers. The study will be supported by psychiatrists experienced in group administration of psychedelics as well as by our therapists-in-training. It will be an excellent opportunity to start building a platform for shared knowledge and professional development for mental health professionals interested in the emergent field of psychedelic research and therapy.

A Pre-Investigational New Drug meeting with the FDA (US Food and Drugs Administration) is planned for January 2018. We plan to share the results of the EMA Scientific Advice with FDA and seek approval for the replication of the confirmatory phase of our TRD trial in the US.

We are always on the lookout for talent. With scientific rigour and patient experience at the core of our work, we plan to hire a lead for therapy research and training, early next year.

We continue to be humbled and inspired by the task ahead of us. We are immensely grateful for the enthusiasm and expertise that has been so generously shared by everyone involved. Thank you for all of your support, it has made such a difference to our work and will undoubtedly make a difference in patients’ lives.

I wish you the happiest of festive seasons and all the best for the New Year.

Kind regards,

Katya, on behalf of George, Lars and the COMPASS team

COMPASS Pathways receives FDA approval for psilocybin therapy clinical trial for treatment-resistant depression

Regulatory approvals for the trial have already been given in the UK, the Netherlands and Canada.

COMPASS Pathways News | July 2018 Issue

This is a newsletter from COMPASS, highlighting recent and forthcoming events and developments that are relevant to us, our partners and healthcare system stakeholders.

COMPASS Pathways News | December 2017 Issue

The holiday season is approaching, and as we begin dreaming of festive treats and spending the holidays cocooned in thick duvets with a cup of hot chocolate in hand, I would like to reflect on our journey this past year and share a few 2017 highlights.

In the news

The renaissance of psilocybin as a viable treatment option

Article from pharmaceutical-technology.com listing current clinical trials involving psilocybin.

Q&A: Compass Pathways’ Goldsmith on fighting depression with psilocybin

The British startup is about to begin the largest clinical trial ever to test whether psilocybin can be used to treat depression

‘Reluctant Psychonaut’ Michael Pollan Embraces The ‘New Science’ Of Psychedelics

National Public Radio Fresh Air podcast with Michael Pollan on his new book “How to change your mind”.

Science & technology

The renaissance of psilocybin as a viable treatment option

Article from pharmaceutical-technology.com listing current clinical trials involving psilocybin.

Mushroom Emerge From Underground

“Magic mushrooms show promise to treat depression and anxiety–and major academic institutions and Silicon Valley are stepping up research and investment. The wellness travel space, in very creative ways, is moving from experiential to truly emotional and transformative travel.”

Patient experience

Psychedelic Healing

Could magic mushrooms help reboot the brain? Article from BBC Focus Magazine focusing on the experience of Kirk Rutter, a participant in the Imperial College psilocybin therapy study

Can Magic Mushrooms Provide Lasting Peace?

Psilocybin has been illegal in the United States for more than 40 years. But Mr. Mihai, who had just finished treatment for Stage 3 Hodgkin’s lymphoma, was participating in a study looking at whether the drug can reduce anxiety and depression in cancer patients.

Just One Dose of This Psychedelic Drug Can Ease Anxiety

In two new studies released simultaneously by researchers at New York University and Johns Hopkins, doctors reveal that a single dose of psilocybin—a compound from magic mushrooms—can ease anxiety and depression for up to six months.

Roland Griffiths Talks About Psilocybin Research

Insights from Professor Roland Griffiths into the psilocybin research carried out at Johns Hopkins University looking at anxiety, depression and psychological distress in cancer patients.