Quantum BioPharma Announces the Success of unbuzzd™ Clinical Trial
NASDAQ: QNTM | CSE: QNTM | FRA: 0K91 | Upstream: QNTM
Overview
Quantum BioPharma Ltd. announced that it has completed a double-blind, randomized, placebo-controlled crossover design clinical trial (NCT06505239) of its dietary supplement product unbuzzd™, investigating its effects on alcohol intoxication and alcohol metabolism, according to the company.
According to the company, results of data analysis show definitively that unbuzzd™ accelerated the rate at which Blood Alcohol Concentration ("BAC") was reduced in study subjects, while simultaneously reducing the symptoms of intoxication and hangover. The company stated that all these results were statistically significant compared to placebo. Study participants were both male and female and between the ages of 21 and 43, with weights ranging from 119 to 232 pounds, according to the company. The company said the positive effects of unbuzzd™ were rapidly apparent, occurring within 30 minutes after consumption of the dissolved powder, and that unbuzzd™ was well-tolerated and safe, with no reported product-related adverse effects.
Key Highlights
- Accelerated Alcohol Metabolism: unbuzzd™ dramatically and rapidly reduced blood alcohol concentration in study participants, with the rate at which BAC was lowered, on average for most participants, more than 40 percent faster within 30 minutes of consuming unbuzzd™ compared to control subjects, according to the company. This faster reduction of BAC was statistically significant compared to placebo and was observed at each subsequent measurement of BAC over a four-hour period.
- Rapid Improvements in Alertness: Study participants reported statistically significant improvement in alertness as soon as 30 minutes after consuming unbuzzd™, and made fewer cognitive errors within 30 minutes of consuming the product, significantly outperforming placebo results, according to the company.
- Rapid Improvements in Physiologic Changes due to Intoxication: unbuzzd™ lessened the elevation in heart rate and the drop in blood pressure that often accompanies alcohol intoxication, stabilizing both, a result the company said was statistically significant.
- Reduced Perceived Impairment and Mental Fatigue: unbuzzd™ helped alleviate perceived impairment and mental fatigue caused by alcohol intoxication, according to the company.
- Hangover Relief: Participants noted a statistically significant reduction in hangover symptoms, including reduced cognitive and physical impairment and reduced headache compared to placebo results, at both four hours (67 percent reduction in headache severity) and eight hours after consuming unbuzzd™, according to the company.
- No Side Effects: unbuzzd™ was well-tolerated by all study participants, with no reported adverse side effects, the company stated.
Strategic/Operational Context
According to the company, unbuzzd™ is a proprietary blend of vitamins and supplements developed by a world-class team of scientists at Quantum BioPharma, and the double-blind, placebo-controlled crossover study shows, with statistical significance, that unbuzzd™ accelerates the metabolism of alcohol and speeds the lowering of blood alcohol concentration. The company stated that study participants concurrently rapidly restored their mental alertness, reduced their perceived impairment and fatigue, and avoided the worst effects of a hangover.
"We are thrilled to see such significant and meaningful outcomes in this clinical study. This study confirms the exceptional overall performance of unbuzzd™ to help reduce the acute effects of alcohol intoxication," said Dr. Andrzej Chruscinski, Vice President of Clinical and Scientific Affairs at Quantum Biopharma, according to the company. "We are also pleased to see that there were no product-related side effects or safety concerns in this clinical study."
Zeeshan Saeed, CEO of Quantum BioPharma, added, "This clinical trial shows that unbuzzd™ is an important addition to the safe and responsible consumption of alcohol. Consumers now have the benefit of knowing that unbuzzd™ can reduce alcohol intoxication, speed the reduction of blood alcohol concentration, restore mental alertness and well-being, and help them avoid the worst symptoms of a hangover."
According to the company, the formula for unbuzzd™ is licensed to Celly Nutrition Corp. and is currently available at unbuzzd.com. unbuzzd™ is a registered trademark of Celly Nutrition Corp. The company noted that individual results may vary, unbuzzd™ is a dietary supplement, and that consuming unbuzzd™ after alcohol ingestion does not permit operation of a vehicle.
About Quantum BioPharma Ltd.
Quantum BioPharma 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"), Quantum BioPharma is focused on the research and development of its lead compound, 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. Quantum BioPharma invented UNBUZZD™ and spun out its OTC version to a company, Celly Nutrition Corp. ("Celly Nutrition"), led by industry veterans. Quantum BioPharma retains ownership of 25.71% (as of June 30, 2024) of Celly Nutrition at www.unbuzzd.com. The agreement with Celly Nutrition also includes royalty payments of 7% of sales from unbuzzd™ until payments to Quantum BioPharma total $250 million. Once $250 million is reached, the royalty drops to 3% in perpetuity. Quantum BioPharma retains 100% of the rights to develop similar products or alternative formulations specifically for pharmaceutical and medical uses. Quantum BioPharma maintains a portfolio of strategic investments through its wholly owned subsidiary, FSD Strategic Investments Inc., which represents loans secured by residential or commercial property.
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