FSD Pharma (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9A), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions to address ailments affecting millions worldwide, has submitted a Clinical Trial Application (“CTA”) for its planned phase-1b clinical trial. According to the announcement, the trial will focus on evaluating the safety and efficacy of unbuzzd(TM) in healthy volunteers in an induced state of alcohol intoxication. The application is the first step in receiving approval to begin the trial; the application will be reviewed by an Australian human ethics review committee (“HREC”). Pending approval, the company anticipates beginning to recruit volunteers in April. A dietary supplement product under development for potential marketing in the United States, unbuzzd(TM) is a fortified oral liquid formula containing natural ingredients, vitamins and other food supplements designed to enhance cognition and replenish cofactors needed for alcohol metabolism; the company noted that the formula has potential to accelerate the rate of alcohol metabolism in the body, restore mental alertness and improve cognition post-alcohol consumption.
“This marks the culmination of several months of intense work by the FSD team and by our expert advisors, conceptualizing and designing this meaningful clinical trial to assess the safety and efficacy of this exciting product on people who drink alcohol,” said FSD Pharma vice president of scientific and clinical affairs Dr. Andrzej Chruscinski in the press release. “We look forward to working closely and swiftly with our Australian partners and the ethics committee on this project.”
To view the full press release, visit https://ibn.fm/rMGhu
About FSD Pharma Inc.
FSD is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development. Through its wholly owned subsidiary, Lucid Psycheceuticals Inc. (“Lucid”), FSD is focused on the research and development of its lead compound, Lucid-MS (formerly Lucid-21-302) (“Lucid-MS”). Lucid-MS is a patented new chemical entity shown to prevent and reverse myelin degradation, the underlying mechanism of multiple sclerosis, in preclinical models. FSD Pharma has also licensed unbuzzd(TM), a proprietary formulation of natural ingredients, vitamins and minerals to help with liver and brain function for the purposes of quickly relieving individuals from the effects of alcohol consumption for use in the consumer recreational sector, to Celly Nutrition Corp; FSD is entitled to a royalty on the revenue generated by Celly Nu from sales of products created using the technology rights granted under the licensing agreement. FSD continues its R&D activities to develop novel formulations for alcohol misuse disorders and continues the development of such treatments for use in the healthcare sector. FSD Pharma also maintains a portfolio of strategic investments through its wholly owned subsidiary, FSD Strategic Investments Inc., which represent loans secured by residential or commercial property. For more information about the company, please visit www.FSDPharma.com.
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