Psychedelics biotechs Nova Mentis Life Science Corp. (OTCQB:NMLSF) and Wellbeing Digital Sciences Inc. (OTC:KONEF)'s subsidiary KGK Sciences Inc. have submitted the first-ever Phase 2a Clinical Trial Application (CTA) to test safety and efficacy of oral microdose of proprietary psilocybin NM-1001 for cognitive and behavioral symptoms associated with Fragile X Syndrome (FXS) to Health Canada.

FXS is the leading genetic cause of autism spectrum disorder (ASD), and NOVA is applying to commence the Phase 2 study via its partner and Contract Research Organization (CRO), KGK, while recently completing the production of its cGMP synthetic psilocybin 1.5 mg microdose capsules to be used in the trial.

NOVA's scientific advisory board chairman Dr. Marvin S. Hausman explained that the company's drug development plan "is to initially establish the therapeutic potential of repetitive low-dose psilocybin to adults with FXS to improve behavioral and cognitive symptoms."

NOVA's president and CEO William Rascan further added that the study is "the first human clinical study of psilocybin for FXS," and that it is intended to support an orphan drug submission with both the U.S. FDA and European Medicines Agency.

"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 continue to make considerable progress towards successful treatment of ASD and FXS, currently unmet medical needs," Rascan said.

On behalf of Wellbeing and KGK, CEO Najla Guthrie agreed that it is "an exciting time" for both partners, and further added: "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."

The CTA is subject to a 30-day review by Health Canada and, if approved, the partners intend to begin the open-label 10-patient study in early 2023.

Photo courtesy of geralt and sergeitokmakov on Pixabay.