CB2 Insights, a data-driven company focused on bringing real-world evidence driven from the point-of-care to the medical cannabis community, announced it has partnered with Licensed Producer, Vireo Health International Inc., to advance the proof of safety and efficacy for cannabinoid therapy as it relates to metered-dosing for patients with ailments in which cannabis-based medicine is believed to support. CB2 will oversee the protocol development and Investigational New Drug (IND) Application directly with the US Food & Drug Administration (FDA). The successful completion will position Vireo for industry leadership when it comes to cannabis-based topical medication used to treat pain. Vireo will also license the Company’s Sail technology platform for full data collection and management.
“Vireo is a cannabis company that understands the importance of full-scale research to prove out the true safety and efficacy of their products as they come to market,” said Prad Sekar, CEO, CB2 Insights. “As we have seen with the FDA over the past year, they are steadfast in ensuring that cannabis-based medicines follow the same protocols as other traditional pharmaceuticals. We are proud to have been chosen to advance that process with Vireo as we move forward with the IND application.”
Vireo is a physician-founded, science-focused vertically integrated cannabis company focused on bringing medical science and engineering effective cannabis-based medicine. Thousands of patients across seven U.S. states have used Vireo’s products for a wide range of conditions including chronic pain, cancer, epilepsy and many others as permitted under various state laws. Vireo’s line of cannabis-based topical products – currently available in Minnesota and scheduled to launch in other markets in 2020 – will be the focus of this project. CB2 Insights will manage the process of designing the protocol and working with the FDA on IND application approval.
“At Vireo, we are working to illustrate the positive impact that cannabis-based products can have for patients seeking to manage chronic or intractable pain through alternative treatment options,” said Kyle Kingsley, M.D. Chief Executive Officer, Vireo Health. “Our partnership with CB2 Insights will help us solidify the understanding and acceptance of cannabis-based medicine by following traditional healthcare protocols to achieve what many others in this space have been unable to do – produce clinical evidence of our products’ efficacy.”
CB2 Insights has active technology, data and research projects in North America, the UK and Colombia. As a cannabis-focused Contract Research Organization (CRO), the Company is able to support Licensed Producers, Multi-State Operators and other industry stakeholders from pre-clinical trial activities through to product commercialization by following traditional healthcare protocols regardless of the jurisdiction. CB2 also owns and operates the largest multi-state cannabis evaluation and education centers in the US, overseeing the care of more than 100,000 patients which expedites the development of patient registries and ultimately recruitment for clinical studies.
Both companies look to complete the initial stage of the project by Q1 2020.