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FSD Pharma Inc (2)
Symbol HUGE
Shares Issued 39,358,863
Close 2024-03-11 C$ 1.06
Market Cap C$ 41,720,395
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FSD applies for unbuzzd phase 1b trial approval

2024-03-11 11:17 ET - News Release

Dr. Andrzej Chruscinski reports

FSD PHARMA SUBMITS A PHASE-1B CLINICAL TRIAL APPLICATION FOR ETHICS COMMITTEE FOR ITS PROPRIETARY BEVERAGE UNBUZZD(TM)

FSD Pharma Inc. has submitted the company's clinical trial application (CTA) for a planned phase 1b clinical trial to assess the safety and efficacy of unbuzzd in healthy volunteers in an induced state of alcohol intoxication (Metal-1 trial). This clinical trial application is submitted for review by a human ethics review committee (HREC) in Australia, a first step to obtain permission to initiate the clinical trial. Recruitment of healthy volunteers to this trial is expected to begin this April, following approval by the HREC.

unbuzzd is the dietary supplement product under development for potential marketing in the United States. unbuzzd is a fortified oral liquid formula with natural ingredients, vitamins and other food supplements that potentially enhances cognition, replenishes co-factors needed for alcohol metabolism and has the shown to accelerate the rate of alcohol metabolism in the body.

"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. We look forward to working closely and swiftly with our Australian partners and the ethics committee on this project," said Dr. Andrzej Chruscinski, vice-president, scientific and clinical affairs at FSD Pharma.

John Duffy, the current chief executive officer of Celly Nutrition, said: "unbuzzd has been developed to accelerate the metabolism of alcohol, restore mental alertness and improve cognition postalcohol consumption. This development has been based on science alone, the phase 1b clinical trial is another example of FSD Pharma Inc.'s commitment to the efficacy of unbuzzd. The Celly Nutrition team looks forward to bringing this cutting-edge innovation to consumers across the United States."

Mr. Duffy, among other companies, previously worked for Coca-Cola (NYSE: KO) for 22-plus years, including serving as vice-president for national sales for Coca-Cola.

Gerry David, CEO (retired) of Celsius Energy Drink (Nasdaq: CELH), stated that: "I truly see unbuzzd as a product that will affect so many lives in such a positive way. I look forward to helping make unbuzzd a mainstream success."

About FSD Pharma Inc.

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., FSD is focused on the research and development of its lead compound, Lucid-MS (formerly Lucid-21-302). 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. 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 research and development activities to develop novel formulations for alcohol misuse disorders and continues the development of such treatments for use in the health care sector. FSD maintains a portfolio of strategic investments through its wholly owned subsidiary, FSD Strategic Investments Inc., which represent loans secured by residential or commercial property.

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