Charlotte’s Web Holdings Inc. is partnering with a subsidiary of British American Tobacco PLC and AJNA BioSciences PBC to seek U.S. Food and Drug Administration (FDA) approval for a proprietary full spectrum hemp extract botanical drug using Charlotte’s Web hemp genetics. 

AJNA is a botanical drug development company focused on mental health and neurological disorders. The company’s chief medical advisor, Dr. Orrin Devinsky, will lead the project. The joint venture plans to engage with the FDA to file an Investigational New Drug application and commence Phase I clinical development in 2023. 

Devinsky is an early stakeholder in AJNA and is the director of New York University (NYU) Langone’s Comprehensive Epilepsy Center and a professor of Neurology, Neurosurgery, and Psychiatry at NYU Grossman School of Medicine. He was also a principal investigator for the development of the Cannabis-based FDA-approved drug, Epidiolex. 

“As one of the first clinicians to research novel cannabinoids, I am very excited to work on this project. I believe the properties of Cannabis and hemp are well suited for the FDA’s new Botanical Drug Development pathway.” — Devinsky in a statement 

In a press release, Jacques Tortoroli, CEO of Charlotte’s Web said the joint venture “is a capital efficient way for Charlotte’s Web to unlock the value of its intellectual property to advance development of effective botanical alternatives to current neurological pharmaceuticals.”   

The joint venture plans to use its initial $10 million investment for the clinical development of a novel hemp botanical drug. The drug will target a neurological condition that will be identified by the joint venture’s leadership team.  

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