Psilocybin Microdose Capsules Ready for Future Clinical Trial

Psilocybin is a psychedelic substance, but may have therapeutic effects as microdose

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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Nova Mentis is one step closer to testing its psilocybin capsules for fragile X syndrome in a clinical trial.

Capsules containing very small doses (microdoses) of psilocybin are ready to be used in a future Nova Mentis clinical trial, with the company one step closer to testing them as a potential treatment for fragile X syndrome.

The capsules started being produced per chemistry, manufacturing, and control (CMC) guidelines shortly after the company received the green light to get the psilocybin shipped from the U.S. into Canada.

Also ready is a package of information that describes the instructions for manufacturing the psilocybin capsules and how they dissolve to meet regulatory requirements. It also contains records that confirm the final batch has been produced. This is done to ensure the capsules are safe and consistent between batches.

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With this information in hand, the company, together with KGK Science, a Wellbeing subsidiary, can ask Health Canada for the go-ahead to launch a Phase 2a clinical trial to test a microdose of 1.5 mg psilocybin for fragile X syndrome.

“The clinical trial application … will be submitted to Health Canada for approval of a Phase 2a study evaluation psilocybin microdose therapy for fragile X syndrome, the leading cause of autism spectrum disorder (ASD),” Najla Guthrie, CEO of Wellbeing Digital and KGK, said in a press release.

Fragile X syndrome is caused by a mutation in the FMR1 gene in the X chromosome. It can result in a range of symptoms, from developmental delays and learning difficulties to anxiety and hyperactive behavior. People with fragile X are also more likely to fall on the autism spectrum and have problems with communication and social interaction.

Psilocybin is a psychedelic substance that causes hallucinations, from distortions in sensations to changes in mood and thought processes. In a microdose, psilocybin doesn’t act as a hallucinogenic, but instead may have therapeutic effects.

Earlier this year, Nova Mentis announced that treatment with repeated microdoses of psilocybin significantly improved cognitive and behavioral problems in an animal model of fragile X syndrome.

While the company has received orphan drug designation in the U.S. and European Union to use it for fragile X syndrome, it plans to extend its indication to other diseases.

“Nova is excited to initiate the availability of its 1.5 mg psilocybin capsules to doctors, clinics and pharmaceutical companies in Canada for its potential therapeutic use in non-ASD clinical trials, including but not limited to diabetes, heart disease, epileptic conditions and post-traumatic stress disorder (PTSD),” Will Rascan, president and CEO of Nova, said.