DeFloria announced Monday that the Federal Drug Administration had approved the company’s request to start a Phase 2-clinical trial of AJA001. This oral cannabinoid is being developed to treat the symptoms associated with autism spectrum disorder.
It was founded in 2023, as a joint venture between Charlotte’s Web and Ajna BioSciences. (NYSE: BTI)BAT plans to launch the trial in mid-2025. BAT has an equity interest through 200,000 preferential units, following a $10 million initial investment. Charlotte’s Web holds 400,000 voting unit commons and Ajna 400,000.
DeFloria’s CEO Jared Stanley stated that “the IND submission of AJA001, and the initiation in the US of Phase 2 studies mark a historical moment in our quest to develop a botanical drug therapy which is systemically absorbed. This product must also meet FDA guidelines for advanced clinical tests.”
This 12-week trial will be conducted on 60 young people and adolescents with autism, aged 13-29. The goal is to determine the dosage levels that can be used in future studies.
AJA001 contains cannabidiol, a primary CBD ingredient. The product was created using Charlotte’s Web’s genetics of hemp.
DeFloria says that Autism affects 1 in 36 kids and is worth $4 billion in the U.S. This market grows more than 4 percent annually. Current treatment options are limited to just two approved drugs – antipsychotics that often cause side effects and compliance problems.
Orrin Devnsky MD, chief medical advisor for DeFloria said, “There’s strong evidence supporting cannabinoids as a potential treatment of autism spectrum disorder. This will hopefully be safer and more efficient than the current treatments available.”
Charlotte’s Web is the basis for drug development.
Joel Stanley is CEO of Ajna BioSciences. He also serves as Chairman of DeFloria’s board. Sanjay Gupta’s CNN story about Charlotte Figi brought the cannabinoids onto the radar of the public and sparked a worldwide movement.
Bill Morachnick, CEO of Charlotte’s web, emphasized that this was a significant milestone for the company in extending its leadership from the “consumer sector” into the regulated health sector.
DeFloria will also be conducting a separate study in Australia on AJA001 for pediatrics in 2025.