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FSD Pharma has received Institutional Review Board (IRB) approval for its METAL-2 trial in the USA to study the safety and efficacy of Unbuzzd(TM) in acute alcohol intoxication. This approval allows the company to begin recruiting participants and planning the clinical study. Dr. Andrzej Chruscinski, Vice-President of Clinical and Scientific Affairs, emphasized the significance of this milestone in advancing research on acute alcohol intoxication.
On May 29, 2024, FSD Pharma (NASDAQ:HUGE) announced that the United States District Court for the Eastern District of Pennsylvania confirmed the company's Petition to Confirm Arbitration Awards against Dr. Raza Bokhari, its former CEO. The awards, issued by a Canadian arbitrator in 2022, total over CAD $3 million plus interest. The court found no valid basis to deny enforcement under the New York Convention. This legal victory follows Bokhari's termination in July 2021 and his unsuccessful arbitration challenge.
FSD Pharma has submitted a clinical trial protocol for Unbuzzd™, aimed at studying its safety and efficacy in treating acute alcohol intoxication. The METAL-2 trial will be conducted with healthy volunteers in a crossover design. The protocol is awaiting approval from an institutional review board (IRB) in the USA. Recruitment for the trial will commence once approval is granted. Dr. Andrzej Chruscinski, Vice-President of Clinical and Scientific Affairs at FSD Pharma, expressed enthusiasm about reaching this milestone.
On May 24, 2024, FSD Pharma announced an investor relations services agreement with IR Agency, starting on May 22, 2024. The agreement aims to enhance communication with the financial community through creating company profiles, media distribution, and building a digital community. The service will last one month and cost C$335,699 (approximately US$245,000). The IR Agency, led by Rafael Pereira, is independent of FSD Pharma and holds no equity interest in the company's securities. The agency will work from May 28, 2024, to June 28, 2024, to help the company achieve its communication goals.
On May 16, 2024, FSD Pharma and Celly Nutrition announced new packaging and logo for their beverage product, unbuzzd™. The product, designed to aid in alcohol metabolism and promote alertness, will launch this summer. The new design, developed with Six+One, features a vibrant green and yellow color scheme and a playful logo to appeal to a broad demographic. The packaging will be available in various formats, emphasizing the product's scientific development and benefits. Unbuzzd™ aims to balance fun with responsibility, promoting safe and mindful consumption.
FSD Pharma, a biopharmaceutical company, has submitted a Phase-1 clinical trial application for Lucid-21-302 in Australia. Lucid-21-302 is a neuroprotective compound for the treatment of multiple sclerosis, showing promise in preclinical models. The company aims to advance Lucid-21-302 into a phase-2 clinical trial, with optimism about its potential as a treatment for MS.
FSD Pharma signed an 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. The trial will compare the effects of unbuzzd(TM) to a placebo in thirty healthy volunteers. FSD Pharma aims to establish itself as a leader in products targeting alcohol intoxication.
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