Brains Bioceutical Corp. announced the initiation of a clinical trial, using an EU-GMP grade CBD API from its wholly-owned subsidiary BSPG Laboratories.
As part of this study initiation, the Icahn School of Medicine at Mount Sinai in New York is initiating the PK study with Brains Bio’s oral drug formulation of CBD in a hard gelatin capsule. This preliminary data will be used as a foundation for potential future clinical trials in opioid addiction studies as well as other related disorders. It will serve as a valuable addition to Brains Bio’s ongoing clinical trials, research and development and augment the company’s intellectual property portfolio.
Icahn Mount Sinai is world-renowned in medical and scientific training, biomedical research and patient care. It is the medical school for the Mount Sinai Health System, which includes eight hospital campuses and has more than 7,000 faculty members and nearly 4,500 students, residents and fellows. Mount Sinai is focused on the pursuit of intellectual exchange, breakthrough research and multidisciplinary teamwork in biomedical discoveries and advances.
“We are implementing a global first within the CBD industry for this type of research with the Icahn School of Medicine at Mount Sinai, which we hope will inspire further research across the globe,” said Ricky Brar, chairman and CEO of Brains Bio. “I’m very proud of this accomplishment, wherein we have combined our strengths in producing pharmaceutical CBD API to create a unique partnership with an esteemed clinical research organization and initiate a landmark clinical trial.”
“Our multidisciplinary research investigates the neurobiology underlying addiction disorders and related psychiatric illnesses,” said Yasmin Hurd, PhD, Ward-Coleman chair of translational neuroscience and the director of the Addiction Institute at Mount Sinai. “We are proud to be further exploring the possibilities of CBD and its therapeutic effects. Mount Sinai is committed to the pursuit of ideas that often challenge conventional wisdom to revolutionize the practice of medicine and produce dramatically better outcomes for patients.”
The team of scientists and executives at Brains Bio continues to achieve milestones with a relentless pursuit of historic firsts in the CBD industry. Brains Bio has participated in over 13 clinical trials across the globe in various therapeutic disciplines.
“We look forward to monetizing and capitalizing on the resulting market opportunities that will result from this study,” said Brar. “When it comes to the CBD industry as a whole, patients and consumers are demanding research. We are proud to be able to play a part in addressing this critical gap in the emerging industry.”
Since 2014, Brains Bio’s subsidiary, BSPG Laboratories, located in Sandwich, Kent, U.K., has excelled in clinical-stage, natural source, cannabinoid manufacturing. Brains Bio presently has Medicines and Healthcare Products Regulatory Agency’s (MHRA) approval to manufacture pharmaceutical-grade ingredients (API) for the global pharmaceutical industry.
Headquartered in Vancouver, Canada, with operations in the United Kingdom, Brains Bio is one of the only producers of natural hemp-based cannabinoid APIs in the world. The company has unparalleled expertise and institutional knowledge in biotechnology, pharmaceuticals and cannabinoid-based product development.