Charlotte’s Web Holdings, Inc. (TSX: CWEB, OTCQX: CWBHF) has announced significant progress in its collaboration with DeFloria LLC, particularly regarding the clinical development of AJA001, a botanical drug aimed at treating symptoms of Autism Spectrum Disorder (ASD). The findings from the Phase 1 clinical trial were recently presented by Dr. Marcel Bonn-Miller at the American College of Neuropsychopharmacology Annual Meeting, highlighting the potential of this innovative therapy.
AJA001 is an oral solution developed by DeFloria, which combines a multi-compound hemp extract that encompasses a full spectrum of cannabinoids. This formulation seeks to bridge the gap between traditional wellness products and FDA-regulated pharmaceuticals. Utilizing a proprietary hemp cultivar patented by Charlotte’s Web, the Phase 1 trial focused on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of AJA001. Results indicated that the drug was well-tolerated across a broad range of doses, providing essential data for establishing dosing protocols for subsequent Phase 2 trials.
Charlotte’s Web co-founded DeFloria to pioneer innovative therapies for health conditions that are often underserved, such as ASD. The multi-cannabinoid formulation of AJA001 illustrates the potential of botanical drug development to create new therapeutic solutions. Dr. Bonn-Miller emphasized that these findings mark a crucial step in integrating botanical therapies into modern medicine, reinforcing Charlotte’s Web’s mission to cater to diverse health needs.
Bill Morachnick, CEO of Charlotte’s Web, noted that the results from DeFloria’s Phase 1 trial validate their strategic vision to advance botanical science through pharmaceutical avenues. He highlighted how their proprietary genetics and expertise in hemp cultivation could unlock significant value beyond their core wellness offerings, potentially opening new markets and revenue streams.
DeFloria is preparing to submit the Phase 1 trial data as part of its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). If approved, this will pave the way for Phase 2 clinical trials aimed at exploring AJA001’s therapeutic potential in alleviating behavioral symptoms associated with ASD and enhancing quality of life for affected individuals.
The anticipated Phase 2 trials represent a critical step toward FDA approval and broader access to this groundbreaking therapy. As Charlotte’s Web continues to focus on quality, transparency, and innovation, it is strategically positioned to capitalize on emerging opportunities within regulated botanical drug markets.
DeFloria LLC is a joint venture between Charlotte’s Web, AJNA BioSciences PBC, and British American Tobacco PLC (BAT). The company aims to tackle pressing healthcare challenges through innovative multi-compound drugs derived from natural sources. With extensive experience in regulatory affairs and quality-controlled manufacturing among its leadership team, DeFloria is committed to securing FDA approval for its novel botanical drug targeting neurological conditions. Charlotte’s Web’s advancements through DeFloria mark a significant milestone in the integration of botanical therapies into conventional medicine.
