Toronto-based Novamind Inc. a mental health company with a focus on psychedelics, is setting itself up to be the first contract research organization in psychedelic medicine.
Contract research organizations (CROs) offer services intended to reduce the cost of developing new drugs and medicines in specialized markets. They work with biotech, pharmaceutical and medical device companies, as well as research organizations and universities. Many CROs provide support for clinical trials including data management and biopharmaceutical development.
Clinical research on psychedelic medicines is still in its infancy and other companies offering CRO services have not yet entered this market, says Novamind CEO Yaron Conforti.
“The pipeline of clinical trials and psychedelic medicine are in the very early stages,” says Conforti. “The CRO side of this business isn’t going to get big until this pipeline starts moving.”
That pipeline might start with Novamind. The company was founded in 2019 after Conforti partnered with psychiatrist Dr. Reid Robison of Cedar Clinical Research and Cedar Psychiatry, a Utah-based network of psychiatric clinics that offer integrative care, including ketamine-assisted psychotherapy. The goal was to create a model based on infrastructure rather than drug development, says Conforti.
“[It was] an opportunity from a psychiatry perspective to provide both new models of care and delivery of that care, and to focus really on the infrastructure to see that through,” says Conforti.
That approach appears well-suited for this partnership. Conforti brings business savvy as a venture capitalist and entrepreneur with experience building businesses in companies across different industries, including cannabis.
Cedar Clinical Research was part of the Janssen Pharmaceuticals study that supported the development of Johnson & Johnson’s Spravato, an esketamine nasal spray for treatment-resistant depression. Cedar Psychiatry began offering clients Spravato as soon as it was available and is now one of the leading providers of the treatment. To date, Cedar Psychiatry has delivered more than 7,000 ketamine treatments and more than 4,800 Spravato treatments, says Conforti.
“Because of our research background of working with this medicine, we adopted it as soon as it came to market,” says Robison, who is cofounder and medical director of Cedar Psychiatry. “We’re really participating in this mental health revolution that’s long overdue.”
Scaling Clinical and Research Sites
Novamind is now planning to scale Cedar’s existing network of clinical and research sites, says Conforti. In September of 2021, Novamind announced it had opened a sixth integrative psychiatry clinic in Murray, Utah. The new service, dubbed the Murray Clinic, also doubles as Novamind’s third clinical research site.
Novamind also expects to expand to another state by the end of the year, says Conforti.
The Cedar Clinical Research study sites are co-located with the Cedar Psychiatry clinics, and their relationship is symbiotic, says Conforti. As clinic patients are already interested in psychedelic therapies, they provide a pool of possible study subjects that can be recruited for studies of psychedelic medicines.
Cedar Psychiatry Clinic in Layton, UT Cedar Psychiatry Clinic in Draper, UT
This could also help ease some of the challenges of locating patients for studies supported by companies contracting with Novamind CRO services, says Robison. Patients in the Novamind network may have access to upcoming trials and studies that might be relevant to their treatment.
“It really turns out to be a win-win,” says Robison.
Currently, Novamind is partnering with pharmaceutical company Merck on a phase II study of the drug MK-1942 for treatment-resistant depression. According to Robison, Novamind is currently recruiting and enrolling patients for the Merck study.
“We did not have any part in designing that phase of the study, though this is one of our capabilities,” says Robison. “As a selected site, we are responsible for recruiting, screening, and enrolling subjects per the protocol guidelines that were outlined and defined by Merck. We collect and enter all data for these subjects in order for Merck to evaluate the data in real time to determine outcome of trial and medication.”
Every clinical research study at Cedar Clinical Research goes through an institutional review board (IRB) approval process, says Robison. The IRB independently evaluates and monitors the research to make sure it’s ethically acceptable and that the study participants are protected.
There are more patients interested in psychedelic therapies than there are trained clinicians to deliver therapies and that has resulted in a natural bottleneck, says Sam Sabrin, senior advisor to Tabula Rasa and JLS, which invests in companies developing psychedelic-assisted therapies. Sabrin agrees that a CRO with expertise in developing ways to deliver psychedelic therapies could position itself to alleviate that bottleneck.
Including the Psychedelic Experience in Clinical Data
Another important question in designing and executing clinical trials with psychedelic therapies is how the psychedelic experience is incorporated into the trial, says Sabrin. How does a clinical trial account for the experience the group receiving the treatment undergoes compared to the group receiving the placebo? How does the location, ambiance and conversation impact the treatment?
“It’s a nuance that’s important in the psychedelic space because of the trip the patient goes on,” says Sabrin.
Taking these factors into consideration is important for any CRO handling a psychedelic study and the approach it takes could give it a competitive edge against other companies in the field. Novamind has experience with psychedelic-assisted therapies through its ketamine treatments, but Robison says their expertise extends further.
“We don’t consider ourselves a ketamine clinic, we’re really an integrated mental health facility that offers ketamine therapy,” says Robison. “The process is very transferable to other psychedelic compounds because we follow this model of dosing and integration, and so the infrastructure is there to do these longer dosing sessions with one or two therapists present.”
In October 2021, Novamind announced it was launching the Psychedelic Palliative Care program at the Murray Clinic. The program is set to combine psychedelic medicine with psychotherapy, workshops, retreat and group support for both patients and families who are coping with chronic illness and might have limited life expectancy due to a serious illness.
Psychedelic therapies for palliative care are currently being studied by researchers affiliated with several organizations including New York University and John Hopkins University. These studies are demonstrating and documenting the positive impact of psilocybin on the mental health of patients receiving palliative care.
Novamind is also involved in another program delivering ketamine-assisted psychotherapy to frontline workers impacted by COVID-19 related stress. The program, dubbed Frontline KAP, is a partnership between Novamind and the Wholeness Center, a Colorado-based mental health clinic that offers integrative therapies. The program was designed by Robison and the Wholeness Center’s founder Dr. Scott Shannon.
“The clinical pilot started in August 2021 with the recruitment of forty frontline workers and is being delivered in cohorts,” says Robison. “Cohort number one is complete and cohort two is underway. After completing this initial clinical pilot, we hope to roll this Frontline KAP program out more broadly across Novamind clinics.”
Novamind began trading on the Canadian Securities Exchange on Jan. 5, 2021 under the symbol NM. The company raised $15.3 million in funding before going public.
Correction: This story has been updated to reflect that Dr. Reid Robison is a psychiatrist, that he no longer works with the MAPS MDMA-assisted psychotherapy study of eating disorders, and that his name is spelled Robison, not Robinson. In addition to the Murray Clinic, Novamind also has two additional research sites in Draper and Springville, Utah that are currently open.
Images: Courtesy of Novamind. Main image is Cedar Psychiatry Clinic in Layton, UT.