DeFloria, Inc., a collaboration between Ajna BioSciences PBC and Charlotte’s Web Holdings, has received FDA clearance to proceed with a Phase 2 clinical trial of AJA001, a groundbreaking oral cannabinoid drug designed to treat autism spectrum disorder (ASD). The trial is set to begin by mid-2025.
With ASD affecting 1 in 36 children and limited treatment options available, AJA001 aims to offer a safer, more effective alternative to existing therapies. Developed using Charlotte’s Web’s proprietary hemp genetics and extensive research, this multi-cannabinoid botanical drug is setting new standards in pharmaceutical innovation.
The Phase 2 trial will enroll 60 adolescents and young adults (ages 13-29) to evaluate the drug’s efficacy in managing behavioral symptoms associated with ASD. A parallel pediatric study is also planned in Australia.
This milestone marks a significant step toward bringing cannabinoid-based medicine into mainstream healthcare, offering hope to millions affected by ASD.