FSD Pharma Signs Agreement With Ingenu CRO to Conduct a Clinical Trial To Determine the Safety and Efficacy Effects of its Proprietary Blend Beverage unbuzzd(TM)
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Insights
The initiation of a randomized, double-blind, placebo-controlled crossover study to assess the safety and efficacy of a new product, unbuzzd™, by FSD Pharma represents a significant development in the pharmaceutical and biotech industry. This study, known as the METAL-1 TRIAL, is designed to evaluate a dietary supplement that claims to enhance cognition and accelerate alcohol metabolism, potentially allowing individuals to recover faster from the effects of alcohol intoxication.
From a scientific perspective, the formulation of unbuzzd™ appears to incorporate ingredients that replenish cofactors necessary for alcohol metabolism, which could theoretically increase the rate at which alcohol is processed by the body. If successful, this could lead to a new product category within the dietary supplement market, targeting consumers interested in responsible alcohol consumption and quicker recovery from its effects. The implications for healthcare providers could also be significant, especially if the medical version of the product proves effective in clinical settings, offering a tool for managing alcohol intoxication in patients.
However, the success of such a product will heavily depend on the outcomes of the clinical trial. Efficacy and safety are paramount and the trial's design must be robust enough to withstand regulatory scrutiny. Should the trial results be positive and the product gains approval, FSD Pharma would likely see a positive impact on its business operations, market share and investor interest.
Entering the market with a product like unbuzzd™ could potentially disrupt the beverage industry, particularly within the niche of alcohol-related supplements. The partnership with Celly Nutrition Corp. and the involvement of industry veterans such as Gerry David and Kevin Harrington could provide substantial marketing leverage and distribution channels for FSD Pharma. This strategic alliance might be a calculated move to penetrate both recreational and medical markets effectively.
Market trends have shown a growing consumer interest in health and wellness products, including those that claim to mitigate the negative effects of alcohol consumption. Should unbuzzd™ prove to be effective, it could appeal to a broad demographic, from social drinkers to professionals seeking a quick recovery from social events. The potential for adoption in institutional settings such as hospitals and by front line workers provides additional market opportunities.
It's important to note, however, that market success is contingent upon consumer trust and regulatory approval. The product's reception will also depend on the pricing strategy, competitive positioning and effectiveness of the marketing campaign led by Celly Nu. For investors, the long-term potential of this product line could represent an area of growth, but it is also associated with significant risk until the clinical trial results are published and the product's safety and efficacy are validated.
FSD Pharma's announcement regarding the METAL-1 TRIAL could have financial implications for the company and its stakeholders. The development of unbuzzd™ and its subsequent clinical trials represent a considerable investment in research and development. The successful completion of the trial and potential market launch of the product could lead to new revenue streams for the company.
Investors should monitor the progress of the trial closely, as positive results could lead to increased stock value, while any setbacks might have the opposite effect. The partnership with Celly Nu and the involvement of high-profile industry figures could attract investor attention and potentially increase stock liquidity. However, the biotech sector is known for its volatility and outcomes of clinical trials are unpredictable. Therefore, investors should consider the inherent risks associated with investing in a company at this stage of product development.
Additionally, investors should evaluate the company's overall portfolio and risk diversification. If FSD Pharma's portfolio is heavily reliant on the success of unbuzzd™, it may represent a higher risk profile. Conversely, if the company has a diversified portfolio with multiple products in development, the risk may be more balanced. Financial performance post-trial will also depend on the company's ability to scale production, manage costs and navigate the regulatory landscape.
TORONTO, ON / ACCESSWIRE / February 26, 2024 / FSD Pharma Inc. (NASDAQ:HUGE)(CSE:HUGE)(FRA:0K9A) ("FSD Pharma" or the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announced that through its subsidiary, HUGE Biopharma Australia Pty Ltd., it entered into an agreement with Ingenu CRO Pty Ltd on February 19, 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-1 TRIAL)".
This trial is an important step to further verify that the effects of drinking unbuzzd™ helps a person sober up faster from the effects of alcohol. FSD Pharma's proprietary dietary supplement product is called unbuzzd™. unbuzzd™ is a fortified oral liquid formula that potentially enhances cognition, replenishes cofactors needed for alcohol metabolism, and may accelerate the rate of alcohol metabolism in the body allowing a person to sober up faster. Celly Nutrition Corp. ("Celly Nu"), led by beverage and marketing icons Gerry David, former CEO of Celsius, John Duffy former executive of Coca Cola and Kevin Harrington formerly on Shark Tank. Celly Nu is the holder of exclusive rights to FSD Pharma's technology for the recreational sale and use market. Separately FSD Pharma continues to develop a medical based product to accelerate the rate of alcohol metabolism for use in hospitals, medical centres and for front line workers.
"Our R&D team has worked tirelessly over the past year to accumulate science-based information to design the unbuzzd™ recreational alcohol use formulation. This clinical trial is an important next step to delivering science-based evidence to confirm what we believe we have discovered - a discovery which could potentially change the rate at which we metabolize alcohol in the body, or in simple terms sober up faster" said Mr. Zeeshan Saeed, CEO and co-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 maintains a portfolio of strategic investments through its wholly-owned subsidiary, FSD Strategic Investments Inc., which represent loans secured by residential or commercial property.
Cautionary Note Regarding Forward-Looking Information
This press release contains forward-looking statements and forward-looking information (collectively, "forward-looking statements") within the meaning of applicable securities laws. Any statements that are contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements are often identified by terms such as "plans", "expects", "expected", "scheduled", "estimates", "intends", "anticipates", "hopes", "planned" or "believes", or variations of such words and phrases, or states that certain actions, events or results "may", "could", "would", "might", "potentially" or "will" be taken, occur or be achieved. More particularly, and without limitation, this press release contains forward-looking statements contained in this press release include statements concerning the future of FSD Pharma and are based on certain assumptions that FSD Pharma has made in respect thereof as of the date of this press release, including those relating to future sales of Class B Shares under the ATM Offering, the offering price therefor and the use of proceeds thereof. FSD Pharma cannot give any assurance that such forward-looking statements will prove to have been correct.
Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. The Company cautions that although it believes the expectations and material factors and assumptions reflected in these forward-looking statements are reasonable as of the date hereof, there can be no assurance that these expectations, factors and assumptions will prove to be correct and these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to a number of known and unknown risks and uncertainties including, but not limited to: the timing and ability to satisfy all applicable listing and regulatory requirements of the CSE and Nasdaq; the fact that the drug development efforts of the Company and Lucid are at a very early stage; the fact that preclinical drug development is uncertain, and the drug product candidates of the Company and Lucid may never advance to clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of the Company and Lucid; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the potential inability to obtain or maintain regulatory approval of the drug product candidates of the Company and Lucid; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of the Company and Lucid; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected or impacted by unforeseen issues; the potential inability to obtain adequate financing; the potential inability to obtain or maintain intellectual property protection for the drug product candidates of the Company and Lucid; the inability of the Company to sell under the ATM Offering or upon the terms outlined herein; the prices at which the Company may sell the Class B Shares in the ATM Offering; and other risks. Accordingly, readers should not place undue reliance on the forward-looking statements contained in this press release, which speak only as of the date of this press release.
Further information regarding factors that may cause actual results to differ materially are included in the Company's annual and other reports filed from time to time with the Canadian Securities Administrators on SEDAR+ (www.sedarplus.ca) and with the SEC on EDGAR (www.sec.gov), including the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2022, the Prospectus and Registration Statement, each under the heading "Risk Factors". This list of risk factors should not be construed as exhaustive. Readers are cautioned that events or circumstances could cause results to differ materially from those predicted, forecasted or projected. The forward-looking statements contained in this document speak only as of the date of this document. FSD Pharma does not undertake any obligation to publicly update or revise any forward-looking statements or information contained herein, except as required by applicable laws. The forward-looking statements contained in this document are expressly qualified by this cautionary statement.
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Contacts:
FSD Pharma Inc.
Zeeshan Saeed, Founder, CEO and Executive Co-Chairman of the Board, FSD Pharma Inc.
Email: Zsaeed@fsdpharma.com
Telephone: (416) 854-8884
Investor Relations
Email: ir@fsdpharma.com, info@fsdpharma.com
Website: www.fsdpharma.com
SOURCE: FSD Pharma Inc.
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