Psychedelic Partnership To Test Psilocybin For FXS In First Phase 2 Clinical Trial

Psychedelics biotechs Nova Mentis Life Science Corp. NMLSF and Wellbeing Digital Sciences Inc. 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.

Market News and Data brought to you by Benzinga APIs
Posted In: CannabisNewsPenny StocksPsychedelicsMarketsHealth Canada Approvalpsilocybin therapiesPsychedelics Research
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

The Benzinga Cannabis Capital Conference is coming to Florida

The Benzinga Cannabis Capital Conference is returning to Florida, in a new venue in Hollywood, on April 16 and 17, 2024. The two-day event at The Diplomat Beach Resort will be a chance for entrepreneurs, both large and small, to network, learn and grow. Renowned for its trendsetting abilities and influence on the future of cannabis, mark your calendars – this conference is the go-to event of the year for the cannabis world.

Get your tickets now on bzcannabis.com – Prices will increase very soon!


Loading...