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Numinus Executives Dish on Details of Its Upcoming Phase 1 Clinical Trial Using Natural Psilocybin

Last week The Dales Report sat down with two key executives at Numinus to learn about the company’s latest milestone: a significant partnership that will allow it to undertake its first clinical trial. Chief Medical Officer Dr. Evan Wood and Science Officer and General Manager Sharan Sidhu provided more information on the partnership with KGK Science, and what it means for the future of psilocybin research.

The clinical trial Numinus will undertake in partnership with the London, Ontario-based contract research company will assess the safety and psychoactive properties of a naturally derived mushroom extract, developed by Numinus. The trial will take place at Numinus Bioscience lab and will enroll 14 participants, with the goal of obtaining data on the safety profile of the extract. 

If successful, Sidhu says the trial would show that “it is possible to use natural sources of medicinal compounds to be able to alleviate some of the mental health issues that we’re seeing.”

Could Natural Psilocybin Be More Beneficial?

In a press release detailing the latest announcement, Sidhu said the company believes there are several advantages to working with naturally occurring psilocybin. She explained to TDR that the company has built up existing data that supports this idea.

“All the experimentation, all the quality data, all the efficacy data, and all of the endpoints are meeting requirements for every single experiment that we are doing, so competency is rising,” she says, “but until we have the data from the end of the trial, we won’t know for sure.”

Dr. Wood outlined the difference in Numinus’ approach with the clinical trial when compared to other firms in the space, and noted that there are already a number of groups pursuing synthetic psilocybin, which is developed using precursor chemicals in a laboratory.

“We’re taking a different approach: we think that not only is natural psilocybin potentially friendlier for the environment—it’s not made with chemicals and you can grow it as an agricultural product—but there’s also molecules that likely coexist with psilocybin that may provide a synergistic benefit,” he said.

A Dream Partnership

Working with KGK Science is no accident. Wood said between Sidhu and himself, the two share a number of relationships with contract research organizations and opted for KGK based on its impressive history. 

“We selected an organization that has a track record with these naturally occurring natural health products, or regulatory strategies for naturally occurring products,” he said. “They have done phase one trials with cannabinoid compounds and things like that, which is a different pathway than if you have a molecule that you have developed in your laboratory and that you want to take through a pharmaceutical drug path.”

The nature of phase one trials is that they can be done very quickly, as the goal is to measure their effects and document their safety—something Numinus could have done on its own, Wood said. Working with KGK, however, will provide the company’s clinical and lab teams with the expert guidance that can only come from having already gone through the trial process many times before.

“They take developers and innovators like Sharan and her team in the laboratory, and myself and my team in the clinic with therapists and physicians, and say, ‘okay, this is protocol… this is how we can get everything that policymakers at the FDA or Health Canada would require to demonstrate that your therapeutic is safe for use in humans’.”

Once that first step is complete, it will open the door to additional, more specific clinical trials.

“We know that mushrooms are safe, but we couldn’t say to Health Canada, ‘trust us’,” Wood said. “We know it has a psychedelic effect, and we know it’s safe. This study enables us to make those determinations.”

Watch the video below to hear the entire conversation, and stay tuned for part two later this week. 

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