TORONTO, ON - May 28, 2024 - FSD Pharma Inc. (NASDAQ:HUGE)(CSE:HUGE)(FRA:0K9A), a biopharmaceutical firm focusing on innovative biotech solutions, has officially submitted a clinical trial protocol for Unbuzzd™, a product aimed at mitigating the effects of acute alcohol intoxication. This submission, part of the METAL-2 trial, is currently under review by an institutional review board (IRB) in the USA, with recruitment of healthy volunteers to commence following IRB approval. The METAL-2 trial employs a crossover design to assess both safety and efficacy.
Dr. Andrzej Chruscinski, Vice-President of Clinical and Scientific Affairs at FSD Pharma, expressed enthusiasm about reaching this milestone, noting the importance of moving closer to clinical assessment of Unbuzzd™.
About FSD Pharma
FSD Pharma is committed to developing a range of innovative assets and biotech solutions for treating neurodegenerative and metabolic disorders as well as alcohol misuse disorders. The company operates through its subsidiary, Lucid Psycheceuticals Inc. ("Lucid"), focusing primarily on Lucid-MS, a patented compound designed to prevent and reverse myelin degradation, a key factor in multiple sclerosis. Lucid-MS has shown promising results in preclinical models.
Additionally, FSD Pharma has licensed Unbuzzd™ to Celly Nutrition Corp. ("Celly Nu") for the consumer recreational market. Unbuzzd™ is a formulation containing natural ingredients, vitamins, and minerals aimed at enhancing liver and brain function to quickly alleviate the effects of alcohol consumption. FSD Pharma earns royalties from the sales of products developed under this licensing agreement. Continuing its R&D efforts, FSD Pharma aims to create novel formulations for treating alcohol misuse disorders within the healthcare sector.
The company also maintains a strategic investment portfolio through its wholly-owned subsidiary, FSD Strategic Investments Inc., involving loans secured by residential or commercial property.
Conclusion
FSD Pharma Inc. continues to advance its innovative biopharmaceutical portfolio, now focusing on the clinical trials for Unbuzzd™ to address acute alcohol intoxication. The company remains dedicated to pioneering treatments for challenging disorders while navigating the inherent risks and uncertainties of early-stage drug development.
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