Phase 2a Trial to Test Microdoses of the Psychedelic Psilocybin in 10 Patients

KGK Science partners with Nova Mentis Life to launch open-label trial

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by Patricia Inácio, PhD |

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KGK Science, a wholly owned subsidiary of Wellbeing Digital Sciences, has entered into an agreement with Nova Mentis Life Science to conduct a Phase 2a clinical trial testing the efficacy of psilocybin as a potential treatment for fragile X syndrome.

The open-label trial will be the first to test the efficacy of very small doses (microdoses) of psilocybin — 1.5 mg — as a means to lessen behavioral and cognitive symptoms associated with fragile X syndrome.

The study, which expects to enroll 10 patients, will be conducted at KGK’s dedicated research facility in Ontario, Canada. An open-label trial, sometimes referred to as “non-masked” or “unblinded” trial, is a study in which participants and researchers are aware of the treatment given.

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Under the terms of the agreement, KGK will be responsible for designing the trial’s protocol, conducting the clinical trial, managing and validating the data, and performing all the statistical analyses. Additionally, the company will take care of regulatory and ethics submissions for the trial and draft the study’s final report.

“We are thrilled to be working with Nova Mentis for their planned phase II clinical trials to test the efficacy of psilocybin-based therapeutics for the treatment of behavioural and cognitive symptoms associated with Fragile X Syndrome,” Najla Guthrie, CEO of Wellbeing and KGK, said in a press release.

“Over the past 25 years, we have successfully helped hundreds of companies with custom designed clinical trials and claim substantiation strategies that move products efficiently into the global markets,” she said.

Psilocybin known for being main psychedelic agent in ‘magic’ mushrooms

Psilocybin is best known for being the main psychedelic agent in “magic” mushrooms. It causes hallucinations that can manifest as distortions in sensations and alterations in mood and thoughts. When given in a microdose, however, psilocybin doesn’t act as a hallucinogenic, but may provide therapeutic effects instead.

In an animal model of fragile X, repeated treatment with microdoses of psilocybin significantly eased cognitive and behavioral problems. This included improvements in recognition memory, or the ability to identify a situation as familiar.

Based on promising preclinical data, psilocybin has been designated an orphan drug in the U.S. and the European Union for fragile X syndrome. This status offers financial incentives and regulatory support to accelerate the development and review of treatment candidates that may significantly benefit people with rare diseases.

The upcoming trial comes on the heels of a green light from the U.S. Drug Enforcement Administration to ship psilocybin into Canada. Nova Mentis expects trial results will be used to support psilocybin’s therapeutic development in fragile X and other conditions.

“Nova’s planned psilocybin treatment of FXS [fragile X syndrome] is a major drug development milestone for our company,” said William Rascan, president and CEO of Nova Mentis.

“We are confident that KGK’s extensive experience in high-quality clinical research trials and expert regulatory support in the space will enable us to make considerable progress towards successful treatment of [autism spectrum disorder] and FXS, currently unmet medical needs,” he added.