This story is part three of a series examining efforts by leading companies to bring psychedelic-assisted therapies to market. In part one, Lindsay Hoover of the JLS Fund discussed the market strategies of five publicly traded companies in the space. In part two, Hoover focused on the drug development initiatives of leading developers of psychedelic medicines. In this final installment of our series, Hoover examines how Cybin is expanding its share of the psychedelic-assisted therapies market by partnering with a chain of 129 clinics providing transcranial magnetic stimulation. Hoover is an investor in Lucid News and JLS has invested in Cybin.
Marketing strategies of some of the top public companies developing psychedelic-assisted therapies must sometimes address the challenges of meshing a clinical model with drug development.
While some companies choose to partner with existing chains providing clinical services, others are building custom clinics. Field Trip has launched a handful of clinics constructed from scratch in the U.S. in Atlanta, New York, Los Angeles, California, Chicago, Houston, and in Toronto and Amsterdam. Field Trip has an ambitious expansion strategy, including an aggressive, intended rollout of 75 clinics by 2024.
Meanwhile, UK-based Compass Pathways has established a Centre of Excellence to accelerate research and improve patient experience in mental health care with Sheppard Pratt, a private, nonprofit provider of mental health, special education, substance use, developmental disability, and social services.
Cybin and Greenbrook Partner For Competitive Advantage
Toronto-based Cybin has taken its own approach to clinical care. According to a recent announcement the company has entered into a collaboration agreement with medical center chain Greenbrook TMS (TSX: GTMS) (NASDAQ: GBNH) to establish Mental Health Centers of Excellence.
Greenbrook operates 129 outpatient mental health service centers in the U.S. Through its company-operated treatment centers, doctors provide transcranial magnetic stimulation (TMS) therapy, a U.S. Food and Drug Administration approved therapy to treat major depressive disorder and other mental health conditions.
Transcranial magnetic stimulation is a non-invasive form of brain stimulation using a changing magnetic field to direct electric current at a specific area of the brain through electromagnetic induction. TMS therapy provides local electromagnetic stimulation to brain regions known to be directly associated with mood regulation. To date, Greenbrook claims to have provided more than 620,000 TMS treatments to over 17,000 patients struggling with symptoms of depression.
According to their collaboration agreement, Cybin and Greenbrook TMS NeuroHealth Centers will work together to establish Mental Health Centers of Excellence to facilitate research and development of innovative psychedelic compound-based therapeutics for patients suffering from depression.
Cybin and Greenbrook say their core values are aligned because both companies are on a mission to assist individuals suffering from depression. Of the 17,000 patients treated in the U.S. by Greenbrook’s affiliated physicians, all of them suffer from major depressive disorder (MDD) and other mental health conditions.
Meanwhile, Cybin is pursuing research and development of novel compounds and delivery mechanisms. The company is building the foundation of what it believes will become the next generation of commercially viable psychedelic therapeutics to treat mental health disorders, including depression.
According to both companies, the network of outpatient mental health service centers that Greenbrook has built over the years will give Cybin a competitive market advantage to access resources and patients to accelerate clinical research in the U.S. This may prove critical as access to patients to participate in research studies can be a challenge for companies developing new therapies.
“Cybin’s collaboration with Greenbrook highlights the potential benefits to drug developers of close partnership with treatment providers, especially in the case of psychedelic medicines, where the treatment methodologies and protocols are anticipated to be an integral aspect of therapeutic success,” says Lindsay Hoover of the JLS Fund.
“The ability to collect meaningful volumes of patient data and gauge the effectiveness of various therapies and their associated delivery methods, and integrate that information into clinical trial design, could be a significant advantage to Cybin; it may even lead to better-informed drug design going forward and the potential to assess off-label uses for approved formulations.”
Cybin’s Mental Health Centers of Excellence
Specific projects to be pursued at Cybin’s Mental Health Center(s) of Excellence will further clinical research of the psychedelic compounds in the company’s development pipeline. The company says that this plan will help them develop a deeper understanding of psychedelic therapeutic delivery and facilitate the recruitment of participants for upcoming clinical trials.
Cybin believes that by forming its Mental Health Centers of Excellence and potentially leveraging outpatient mental health service centers’ future FDA-approved psychedelic medicines, it may provide near-term and long-term value to patients and stakeholders alike.
“We are extremely proud and excited to be working with the world-class team at Greenbrook TMS to establish these important Centers of Excellence. This opportunity to combine our pre-clinical and clinical knowledge of psychedelic therapeutics with Greenbrook’s deep experience in patient care and delivery is unparalleled and serves as a significant step toward establishing a national distribution network for future psychedelic therapies,” said Doug Drysdale, Cybin’s CEO.
Hoover believes that the Greenbrook collaboration is a “brilliant move” for Cybin.
“We at JLS Fund have long appreciated the value of access to patent data and clinical infrastructure to psychedelic drug developers, says Hoover. Cybin has entered into a partnership that can provide valuable insights while allowing the company to continue to focus on its core business without shouldering the financial overhead of clinical operations.”
Drug Development For Targeted Disorders
Part of Cybin’s core business targets two anxiety disorders in developing its proprietary CYB004 molecule.
By seeking to develop therapies that address social anxiety disorder (SAD) and generalized anxiety disorder (GAD), Cybin believes that it can focus on significant areas of unmet need in mental health treatment. SAD is not to be confused with a different emotional affliction with the same acronym – Seasonal Affective Disorder.
In the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), often referred to as the bible or encyclopedic cornerstone of psychiatry, SAD and GAD continue to coexist within the same diagnostic category. Even though they share some features, GAD and SAD (sometimes called social phobia) are particular problems.
Persistent anxiety that is excessive or disproportionate to an actual threat is a characterization of both disorders. People with SAD sometimes experience physical symptoms associated with their anxiety, such as sweating or hyperventilating from panic attacks, as do those with GAD.
According to news reports, SAD is estimated to affect between 3% and 6% of US adults. 1 in 13 adults globally suffers from GAD.
Brain Monitoring For Mental Health Treatments
Cybin has recently sponsored a Kernel Flow feasibility study to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics to understand further and monitor brain activity. The move may signal the company’s entry into ketamine-assisted therapy by using Kernel’s proprietary Kernel Flow device for psychedelic-based studies and clinical trials.
Kernel Flow uses pulsed light instead of continuous-wave light to increase measured brain information. In contrast with electroencephalography (EEG) electrodes that usually require gel on the head or functional magnetic resonance imaging (fMRI) studies that require a participant to lie in a scanner, the Flow device is a wearable helmet. The hardware technology is reminiscent of a helmet from Tron, an envisioned computer extension of the human intellect that uses quantitative neuroimaging technology to measure brain activity in real-time.
Using a wearable helmet during psychedelic treatments could potentially be used for neuroscientific or physiological studies of brain activity during psychedelic experiences. Direct neuroimaging research of psychedelic effects, in vivo, has rarely been attempted and never with a wearable device.
“We still have much to learn about what is occurring in the brain during a psychedelic experience. This first-of-its-kind, Cybin-sponsored study, using the Kernel Flow device, aims to expand our physiological understanding of psychedelic pharmacotherapy,” says Doug Drysdale, Chief Executive Officer of Cybin.
In addition to the partnerships with Greenbrook TMS and Kernel, Cybin announced the scaling up of its European operations and research partnerships with academic and clinical research organizations, including transferring its intellectual property assets to its recently formed wholly-owned Ireland-based subsidiary.
Cybin continues its progression of scaling and building on its IP portfolio of novel psychedelic compounds, delivery platforms, and methods of use in psychiatric indications. Since its inception, the company has progressed several initiatives simultaneously, all of which stem from its growing intellectual property portfolio.
The company expanded its IP portfolio to 12 patent filings and filed an international patent application (PCT) with the potential to obtain patent coverage in 153 countries. It has grown its pipeline of psychedelic molecules to 50+.
Cybin now has four active drug programs using novel psychedelic compounds which target three mental health indications: major depressive disorder, alcohol use disorder, and anxiety disorders (general anxiety disorder/social anxiety disorder). Cybin expects to complete 51 pre-clinical studies to support its progression of novel molecules into clinical studies in early 2022. One study with the University of Washington is a co-sponsored, randomized, placebo-controlled clinical trial of psychedelic-assisted psychotherapy with psilocybin for frontline clinicians experiencing Covid-related distress.
Part 1 of this story looks at the intellectual property (IP) strategies of companies developing psychedelic assisted therapies. Part 2 of this story looks at the challenges of meshing a clinical model with drug development and the market strategies of Cybin and Numinus.
Featured Image: Cybin