Move over space travel, smartphones and New York real estate—soon, many investors will be adding psychedelic drugs to their portfolios. This month, the first psychedelic research company is going public on the NEO stock exchange in Toronto.
Mind Medicine Inc., or “MindMed,” will list on the NEO as it prepares to begin Phase II clinical trials for 18-Methoxycoronaridine (18-MC) to treat opioid use disorder. The company’s synthetic drug is chemically similar to the powerful psychedelic ibogaine, which is derived from the iboga plant. Native to West Africa, iboga has long been used in traditional spiritual practices there, and has become increasingly popular in Western cultures in recent years. Unlike ibogaine, 18-MC has no psychoactive effects, but it shows similar potential to treat both cravings and withdrawal symptoms associated with opioid detoxification.
In September, MindMed acquired biotech company Savant, which had received Canadian federal funding to conduct a Phase I clinical trial on 18-MC. The merger accumulated the resources, staff and knowledge to develop the drug further. That same month, Mindmed finished a $6 million investment round that counted Shark Tank TV host Kevin O’Leary and former Canadian cannabis executive Bruce Linton among its investors.
MindMed’s clinical trials will be conducted in New York under FDA guidance. The company believes that 18-MC can be more easily approved and made accessible in the US. It is also researching therapies with other psychedelics, like LSD, psilocybin and ketamine.
“We believe that hallucinogenic therapies have great merit and benefits for treating addiction,” said co-founder Jamon Rahn. “But, undergoing a ‘psychedelic trip’ might be a daunting proposition to some patients. We want patients to pick up these medicines from their local pharmacy with a prescription. We feel there is an immense opportunity to create next-gen versions of psychedelics for approval as FDA drugs.”
If the company can successfully develop an effective new treatment for opioid use disorder, for example, that would be welcome. But what are the risks of a profit-driven approach to psychedelic therapy and mental health treatment? A British-owned psychedelic research company, COMPASS Pathways, may offer a cautionary tale.
In November 2018, the FDA granted COMPASS special “breakthrough therapy status” to commence clinical trials of psilocybin therapy for treatment-resistant depression. But troublingly, the company then signed an exclusive contract with biotech firm Onyx Pharmaceuticals, which produces pharmaceutical-grade psilocybin—an agreement that effectively prevented any other researchers from pursuing clinical trials.
“In July 2017, Usona Institute, a nonprofit medical research organization, tried to work with Onyx to produce psilocybin in order to study its potential as a depression treatment, but was told that it could not due to Onyx’s contract with Compass,” wrote Olivia Goldhill in an investigative piece for Quartz. “According to multiple sources familiar with the matter and documentation obtained by Quartz, Compass told Usona it would only sell its psilocybin to those doing academic research, and wouldn’t sell to anyone who was doing clinical research to get psilocybin medically approved.”
Worse still, the incentive to reduce costs and maximize profits may have led the company to train therapists too quickly for its clinical trials, including many who had never used psilocybin themselves. An advocate interviewed by Goldhill stressed that having first-hand experience with the drug is critical to being able to give the treatment, likening the situation to a scuba-diving instructor who doesn’t know how to swim.
“Experts further noted Compass’s study protocol includes a number of aspects that appear to reflect a desire to reduce costs, including shorter-than-standard therapist training,” Goldhill wrote.
“According to the experts Quartz spoke with, companies running clinical trials typically face pressure to keep costs low so that, if the FDA were to approve the treatment under study, insurance providers would be willing to cover it in that approved form,” the report continued. “Several of these experts told Quartz that they were concerned that Compass’s trial was designed to be fast, large, and inexpensive, and that it could create risky situations for patients.”
Does MindMed share these problems, and will patients and research participants be placed at similar risk? It’s too soon to know for sure, but market pressures certainly push that way. As the company grows its business and funding, it’s critical that its search for innovative mental health treatments doesn’t risk jeopardizing those very treatments and their widespread adoption.
It would be welcome if MindMed and other psychedelics companies were to show awareness by contributing to efforts to decriminalize and legalize psychedelics in California, Oregon and beyond. Such efforts are designed to ensure that anyone who wants to benefit from these kinds of treatments has the freedom to do so, regardless of whether the FDA or a pharmacy says it’s okay.
Photo by Jp Valery on Unsplash.