Charlotte's Web said the FDA has completed its review of Phase 1 data and Investigational New Drug (IND) application submitted by DeFloria, Inc. The FDA has concluded that DeFloria may now proceed with its planned FDA Phase 2 clinical trial for its botanical pharmaceutical candidate, AJA001 Oral Solution, a treatment for symptoms of autism spectrum disorder (ASD).
"Progressing to Phase 2 of an IND study with the FDA marks an important milestone in the development of our proprietary hemp genetics as regulated medicine," said Bill Morachnick, Chief Executive Officer of Charlotte's Web. "By leveraging our deep expertise in hemp cultivation and proprietary formulations, we are reinforcing and extending our leadership in hemp wellness from the consumer sector into the regulated medical sector. A safe and effective botanical treatment for autism spectrum disorder would be a medical asset that could provide immense value to millions of families and Charlotte's Web."
DeFloria is a collaboration including Charlotte's Web and Ajna BioSciences PBC, a botanical drug development company, to develop AJA001 as a treatment for irritability associated with autism spectrum disorder. AJA001 employs Charlotte's Web proprietary full-spectrum cannabidiol (CBD) hemp extract derived from one of its patented cultivars. DeFloria is developing AJA001 with the Company's proprietary hemp genetics as the foundation of the botanical drug.
"Advancing AJA001 to Phase 2 is a landmark moment for botanical drug development," stated Dr. Marcel Bonn-Miller, Chief Scientific Officer at Charlotte's Web and DeFloria Board Member. "Charlotte's Web has aimed to meet the needs of those underserved by current therapies for the past decade. AJA001's journey through the FDA's botanical drug pathway showcases the wide therapeutical potential of hemp. We feel this research strongly supports cannabinoids as a viable therapy for irritability associated with autism spectrum disorder, which currently lacks adequate treatment options. DeFloria is at the cutting edge with AJA001, and we are eager for DeFloria to begin Phase 2 of development."
DeFloria's planned Phase 2 clinical trial will evaluate the safety, tolerability, and effectiveness of AJA001 among adolescents and adults with ASD, building on the promising results from Phase 1. Data from Phase 2 studies will be used to inform the design of larger Phase 3 clinical trials, the results from which will be submitted to FDA for drug approval.
