FSD Pharma Signs Agreement with Applied Science and Performance Institute (ASPI) to Conduct a Clinical Trial in the United States to Assess the Safety and Efficacy of unbuzzd(TM) in an Induced State of Alcohol Intoxication

TORONTO, ON / ACCESSWIRE / April 30, 2024 / FSD Pharma Inc. (NASDAQ:HUGE)(CSE:HUGE)(FRA:0K9A) ("FSD Pharma" of the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative, inflammatory, and metabolic disorders, today announced that it entered into agreement with Applied Science and Performance Institute (ASPI) in Tampa, Florida, on April 24, 2024 to conduct "A Randomized, Double-Blind, Placebo-Controlled Crossover Study to Assess the Safety and Efficacy of unbuzzd in Healthy Volunteers in an Induced State of Alcohol Intoxication (METAL-2 TRIAL)".

unbuzzd is a unique dietary supplement with natural ingredients, vitamins and GRAS (Generally Recognized as Safe) ingredients that potentially enhances cognition, replenishes cofactors needed for alcohol metabolism, and may accelerate alcohol metabolism in the body. In the METAL-2 trial, the ability of unbuzzd to reverse the effects of acute alcohol intoxication will be compared to a placebo in a crossover design with thirty healthy volunteers randomized in the trial. FSD Pharma licensed this technology to Celly Nutrition Corp. for the recreational sale of unbuzzd.

"We are thrilled to be working with ASPI's agile and experienced team to conduct this study given their expertise in clinical trials with dietary supplements in the health and wellness industry. This trial marks a key milestone and we believe is important in establishing our company as a leader in products targeting alcohol intoxication" said Mr. Zeeshan Saeed, CEO and founder of FSD Pharma.

About FSD Pharma
FSD Pharma 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, 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. ("Celly Nu") and 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 Pharma 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 maintains a portfolio of strategic investments through its wholly-owned subsidiary, FSD Strategic Investments Inc., which represent loans secured by residential or commercial property.