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DeFloria announced Thursday that its experimental cannabis-based drug for autism spectrum disorder showed positive early results, with patients tolerating the treatment well across multiple dose levels.

The drug, AJA001, being developed as a multi-compound hemp extract with a full spectrum of cannabinoids, demonstrated safety at daily doses up to 660 mg when given twice per day, according to results presented at a neuropsychopharmacology conference in Phoenix. The Phase 1 trial included 70 healthy volunteers ranging from 19 to 55 years old.

“We are extremely encouraged by these results,” Marcel O. Bonn-Miller, Ph.D., chief scientific officer at Charlotte’s Web Holdings Inc. and DeFloria board member, said in a statement. He noted that the drug achieved blood concentration levels matching or exceeding existing cannabis-based medicines like Epidiolex.

The Colorado-based company, formed in April as a joint venture between Charlotte’s Web (OTCQX: CWBHF), Ajna BioSciences and British American Tobacco (NYSE: BTI), aims to help address a significant unmet need. About 1 in 36 children may have autism spectrum disorder, according to recent CDC data cited by the company. BAT holds an equity stake through 200,000 preferred units following an initial $10 million investment, with Charlotte’s Web and Ajna each holding 400,000 voting common units.

Common side effects included drowsiness, anxiety, dizziness and headaches, DeFloria reported. One participant receiving a higher 906.4 mg dose experienced anxiety that resolved within a day.

The drug combines multiple cannabinoids from hemp plants, including carefully controlled amounts of CBD and THC. The trial results support testing doses containing up to 395 mg CBD and 15 mg THC daily in future studies.

“Currently available treatments for ASD are not well tolerated, making patient compliance a challenge,” said Jared Stanley, DeFloria’s CEO.

The company is preparing to submit the Phase 1 trial data as part of its Investigational New Drug application to the FDA. If approved, DeFloria plans to explore the drug’s potential for addressing behavioral symptoms and improving quality of life for individuals with autism spectrum disorder in two Phase 2 trials starting in the second quarter of 2025.

The treatment uses hemp extract from Charlotte’s Web’s proprietary CW1AS1 cannabis strain. If successful in later trials, AJA001 could become one of the first FDA-approved botanical drugs derived from hemp for autism spectrum disorder.

“DeFloria’s Phase 1 results validate our strategic vision of advancing botanical science through pharmaceutical pathways,” said Bill Morachnick, CEO of Charlotte’s Web. “This milestone demonstrates how our proprietary genetics and expertise in hemp cultivation can create significant value beyond our core wellness business.”