HempFusion Wellness Announces Toxicology Results from Validcare’s Clinical Study on CBD Liver Safety
DENVER, Colo.–(BUSINESS WIRE)–HempFusion Wellness Inc. (TSX:CBD.U) (OTCQX:CBDHF) (FWB:8OO) (“HempFusion” or the “Company”), a leading health and wellness company offering premium probiotic supplements and products containing CBD, is pleased to announce that Validcare, the organization coordinating the execution of what the Company believes to be the largest human observational, liver and human toxicology study to date, has released its initial findings from the industry sponsored, decentralized human safety study of hemp derived CBD products. The preliminary findings are validating and encouraging, and according to the study’s investigators, there was no evidence of liver toxicity in the 839 participants in the clinical trials.
After seven months of clinical investigation, Validcare announced that its team of principal investigators met with members of the United States Food and Drug Agency’s Cannabis Product Council (formerly known as the Cannabis Work Group) (“FDA” or “Agency”) to share initial findings from the clinical study. This study was commissioned and designed in response to the FDA’s requests, including the Agency’s March 5, 2020 report to the United States Congress for science-based data, so the FDA can confidently determine the appropriate regulatory path(s) for hemp derived CBD products.
“Participating in what is believed to be the largest human liver toxicology study on CBD was a tremendous honor, and the initial findings are incredibly validating for consumer safety,” commented Jason Mitchell, N.D., HempFusion’s Co-Founder and Chief Executive Officer. “We believe this is a pivotal step forward for the CBD industry, and we look forward to continuing to find ways to provide consumers with safe and quality products. When specifically looking at how our products performed in the study, having no liver toxicity only bolsters what we have always stated about our products. We believe they are safe,” continued Dr. Mitchell.
“We are encouraged by these findings and are hopeful this study provides the FDA with sufficient science-based data to determine and take action on a safe regulatory path forward,” commented Dr. Aqua, M.D., Co-Principal Investigator of this IRB-approved study. “We will continue to analyze this real-world data. Due to the overwhelming success, we are adding a second cohort to this study to increase statistical certainty for liver safety and secondary measures across diverse populations and consumers with various medical conditions,” continued Dr. Aqua.
Principal investigators met with the FDA on March 15, 2021 and reviewed preliminary liver safety study results in the form of an abstract. The parties also discussed establishing a direct communication feed to FDA so it can receive raw, blinded, aggregate data for its analysis.
“We understand the significance, importance and immediate need for CBD safety research for the FDA, industry and the US consumer. Validcare is proud to act as a trusted convener for all involved. This first of its kind, industry led, multi-branded study required trust, collaboration, operational excellence, innovation, and resilience. It demonstrates the incredible potential for decentralized clinical research to increase participant access and accelerate results – even during the most challenging times,” said Patrick McCarthy, CEO of Validcare. “We are excited for our principal investigators to continue, expand, and report on this foundational work over the next few months. Once completed, safety results of this study will be shared with participating brands and the FDA. The investigators also plan to publish in a peer reviewed journal.”