TORONTO - FSD Pharma Inc. (NASDAQ:HUGE)(CSE:HUGE)(FRA:0K9A), a biopharmaceutical company, announced today that it has received approval from an institutional review board (IRB) to begin its METAL-2 trial in the United States. This trial will explore treatments for acute alcohol intoxication, a condition affecting millions globally.
The IRB approval is a crucial step that allows FSD Pharma to start recruiting participants and proceed with the clinical study. Dr. Andrzej Chruscinski, Vice-President of Clinical and Scientific Affairs at FSD Pharma, expressed the company's enthusiasm about advancing their clinical research in the U.S., marking a significant milestone for their clinical endeavors.
FSD Pharma is focused on developing innovative solutions for neurodegenerative and metabolic disorders, as well as alcohol misuse disorders. Its lead compound, Lucid-MS, is designed to prevent and reverse myelin degradation, a key factor in multiple sclerosis.
Moreover, the company has spun out its over-the-counter version of unbuzzd™ to Celly Nutrition, retaining a 25.71% ownership as of March 31, 2024, and is entitled to royalty payments from unbuzzd™ sales.
The company also highlighted its substantial tax loss carry forward of approximately CAD$130 million, which could offset tax obligations against future profits. Furthermore, FSD Pharma maintains a portfolio of strategic investments through FSD Strategic Investments Inc., including loans secured by residential or commercial property.
This press release also contains forward-looking statements regarding the company's future, including the potential effects and benefits of unbuzzd™, partnerships, and research and development projects. These statements are based on assumptions and involve risks and uncertainties that could cause actual results to differ materially.
Investors are cautioned not to place undue reliance on these forward-looking statements, which are based on the company's beliefs as of the date of the press release. The company does not undertake any obligation to update these statements, except as required by law.
This news article is based on a press release statement from FSD Pharma Inc. and does not include any independent verification of the claims or forward-looking statements.
In other recent news, FSD Pharma Inc. has been active on multiple fronts. The company has confirmed multiple arbitration awards against its former CEO, Dr. Raza Bokhari, following a dispute over his termination. The financial awards include significant amounts in both USD and CAD, with interest rates ranging from 4% to 6% per annum.
FSD Pharma has also initiated a clinical trial for its dietary supplement, unbuzzd™, designed to potentially counteract alcohol intoxication. The METAL-2 trial, in partnership with the Applied Science and Performance Institute, aims to evaluate the supplement's performance in enhancing cognition and accelerating alcohol metabolism.
In addition, FSD Pharma's subsidiary, Celly Nutrition Corp., has partnered with branding agency Six+One to enhance the market presence of unbuzzd™. The strategic partnership aims to develop a comprehensive brand strategy for the beverage, which is designed to support alcohol metabolism and promote alertness.
Moreover, FSD Pharma has expanded its research into treatments targeting metabolic and related disorders, investigating compounds that may improve liver function, reduce metabolic diseases, and decrease visceral fat. The company has also increased its loan to Celly Nutrition Corp. by $300,000, raising the total to $1.3 million, to support the production of unbuzzd™.
These developments underscore FSD Pharma's ongoing efforts in the biopharmaceutical sector, with a focus on innovative treatments for neurodegenerative and metabolic disorders, as well as alcohol misuse disorders.
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