In The Face of Emerging Research, Numinus’ Upcoming Phase One Trial Is All About Safety And Efficacy
In a recent discussion with The Dales Report, Chief Medical Officer Dr. Evan Wood and Science Officer and General Manager Sharan Sidhu of Numinus discussed the company’s imminent phase one clinical trial, and where it will fit in the current landscape of psilocybin research.
In the past, Numinus has said that one of the main drivers behind its work is the goal of providing patients with access to psychedelic treatment. Until regulations allow the company to do so, the priority for Numinus and for regulators is safety.
“The main objective is always going to be safety first,” said Sidhu. “These products have to be effective, but safety is definitely going to be something that’s on [Health Canada’s] radar. When we’re bringing to them a natural product, we have to show that it’s effective in a healthy population.”
The trial intends to show regulators that the use of natural mushroom extract, which contains more than just the single compound of psilocybin, can be both safe and effective.
What Does Existing Science Say?
Dr. Wood suggested that a recent study published study of psilocybin versus leading antidepressant escitalopram in the New England Journal of Medicine should give people who are new to psychedelics more confidence in its potential.
“It’s about as mainstream as you can get… to have one of the foremost medical journals of the world, where cardiologists, respirologists, and infectious disease doctors will all be reading and learning about psychedelics, [publish the work],” he said.
He says the questions people should be asking about psychedelics and psilocybin specifically should start around efficacy and safety. It’s crucial to learn about potential side effects and compare different approaches, because “for some people, this type of psychedelic experience might not be the best thing.”
“There may be some paths where people think an antidepressant is the approach they want to take,” he said. “Alternatively, people might want to try something in a concise, six-week therapeutic protocol that could get at the roots of their depression or anxiety,” he said.
Existing research shows that those who have participated in the sort of psychedelic therapy protocol he is describing found the experience to be among the most meaningful of their lives, so much so that they could “put depression and anxiety in the rearview mirror.”
Dr. Wood senses a palpable “level of desperation” in the medical community for new mental health treatments, and says interest in psychedelics is being bolstered by demand from the population at large.
Reflecting On Existing Research
“We’re at the beginning of research in these areas, and all data is good data, but we want to see as much data come out so that we have peer-reveiwed references to [work from],” said Sidhu about the NEJM study, as well as other research that is being conducted.
“Data for me is something that’s reproducible, something that’s sustainable. There are positives and negatives with all studies, and it was the same with this one.”
Dr. Wood said the study’s combining of antidepressant medication with intensive psychotherapy is “unrealistic” in real-world terms, something that likely lent to the results of the study’s primary outcome, which found that there was no statistically significant difference between the antidepressant effects of escitalopram and psilocybin.
However, “every secondary endpoint showed a benefit of psilocybin in comparison to the best available thing we have.” Given the results, he says the study clearly shows that psilocybin is a very serious consideration for treatment for depression. He says the proof will be in the details of the follow-up paper.
Synergy As A Team
Looking ahead to their own phase one trial, Sidhu said it speak to how she, Wood, and Numinus’ medical and science teams have worked synergistically to produce something.
“This trial is a really good example of how we can leverage the capabilities and expertise of the primary research, and then the clinical research, and produce results and data that is going to contribute to the value of psilocybin therapy.”
Watch the video above for the full interview.