Psychedelics company Wellbeing Digital Sciences Inc. (OTC:KONEF)'s subsidiary KGK Science Inc. has entered into a research services agreement with Canadian-based biotech Nova Mentis Life Science Corp. (OTC:NMLSF) for a first-of-its-kind Phase 2 clinical trial on psilocybin microdoses' efficacy to improve behavioral and cognitive symptoms associated with the genetic disorder Fragile X syndrome (FXS.) FXS is a genetic condition that causes a range of developmental problems including learning disabilities and cognitive impairment.
The deal foresees KGK being in charge of providing research services, including the development of the clinical trial protocol, regulatory and ethics submissions, conducting the trial, data management and validation, statistical analysis and drafting the final report.
The clinical study is set to be conducted at KGK's research center in London, Ontario, Canada. The small, open-label trial would be used to support Nova Mentis' drug development program under the FDA Orphan Drug designation received in late 2021.
"Nova's planned psilocybin treatment of FXS is a major drug development milestone for our company," stated 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 ASD and FXS, currently unmet medical needs."
Wellbeing and KGK's CEO Najla Guthrie added: "We are thrilled to be working with Nova Mentis for their planned Phase 2 clinical trials. 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."
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