New Oral Microdose Treatment of Autism

Nova Mentis Life Science Corp. announced that it has successfully completed an oral microdose psilocybin preclinical study, in the laboratory of Dr. Viviana Trezza, Rome Tre University, Rome, Italy. The results exceeded all expectations with the findings that a very low dose of the Company’s proprietary psilocybin significantly modulated behavioural and cognitive defects, such as recognition memory, in a genetic model of fragile X syndrome (FXS).    

“The science team led by Dr. Hausman, together with Dr. Viviana Trezza from Roma Tre University, continues to deliver promising preclinical results. The recent oral microdose data set not only confirms but exceeds our original injectable formulation results,” says Will Rascan, CEO of NOVA. “The clear positive data is critical as we prepare to submit our clinical trial application to Health Canada for a Phase 2A study evaluating psilocybin microdose therapy for fragile X syndrome.”

Autism spectrum disorder (ASD) is a complex neurodevelopmental disorder for which no treatments exist. Fragile X syndrome (FXS) is the most common form of inherited intellectual disability and the most frequent monogenic cause of ASD (1). The aim of the present study was to evaluate various oral doses of the company’s proprietary psilocybin in a rat model of FXS. A major question to be answered in this preclinical study was whether microdose therapy could be the potential treatment of choice in ASD, as compared to single dose macrodose therapy with associated hallucinogenic and other side effects.

Psilocybin efficacy was tested in FXS, in the Fmr1 knock-out (Fmr1 KO) rat (Fmr1-Δexon 8) – an established genetic model of FXS (1). Wild type control and Fmr1 KO animals were treated with 0.1 mg/kg and 0.3 mg/kg oral psilocybin every other day for 6 treatments, over a 2-week period, and on day 18 underwent object recognition testing. We had great results! Both 0.1 and 0.3 mg/kg were effective in reversing the cognitive impairment displayed by Fmr1 KO animals. Moreover, the 0.1 mg/kg worked best, and did not have any apparent side effects. The 0.1 mg/kg dose in the rat translates into approximately 1.5 mg oral dose in a 70 kg person.

“I am elated to be able to report to the medical community that at long last we may have opened the door to treatment of ASD, an unmet medical need, that has a devastating impact on the patient, family and society,” stated Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “The rat model that we used mimics key autistic-like features in humans and the study results strongly supports an important role for microdose therapy of

FXS. Moreover, this positive response in the rat of every other day oral 0.1 mg/kg psilocybin, equivalent approximately to a 1.5 mg dose in a 70 kg person, may be the treatment of choice to modulate behavioural changes and cognitive defects, and perhaps have a longer term constructive neuroplastic response in the brain without the need for large doses of psychedelic drugs with associated detrimental hallucinogenic side effects.”