This is the first full-spectrum CBD botanical drug in history to be approved by the FDA for clinical trials.

Recently, DeFloria, a cannabinoid drug company jointly founded by the famous CBD companies Charlotte's Web, Ajna BioSciences and the international tobacco giant British American Tobacco (BAT), announced that its CBD full-spectrum botanical new drug AJA001 for the treatment of autism has been approved by the FDA and will soon start Phase II clinical trials in the United States.

AJA001 is a botanical drug composed of full-spectrum hemp extract (FSHE) derived from the proprietary CW1AS1 cannabis variety. Its main cannabinoid is cannabidiol (CBD) and contains other active cannabinoids. As an innovative multi-cannabinoid botanical drug, it is designed to treat behavioral symptoms associated with autism spectrum disorder (ASD). Due to its diverse mechanisms of action, AJA001 can provide a wide range of therapeutic benefits and is expected to be used in the treatment of various symptoms.

Approximately 1 in 36 children in the United States suffers from autism spectrum disorder, which represents a growing and underserved market with only two FDA-approved conventional drug treatments, both of which are atypical antipsychotics with severe side effects and poor long-term tolerability. Valued at nearly \$4 billion in the United States, with a compound annual growth rate of more than 4%, the market demand is huge.

As the first oral botanical drug that meets cGMP and quality standards, AJA001 sets a benchmark for future drugs of this type. Following FDA approval, DeFloria has initiated volunteer recruitment and plans to recruit 60 participants aged 13 to 29 for a 12-week study to establish a titration regimen and efficacy signal to provide dose level information for the final Phase 3 clinical study.

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About Autism Spectrum Disorder (ASD)

Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental disorder that affects behavior, communication, social interaction and learning ability, with clear stereotyped behavior patterns. It is a lifelong disease that can develop as early as the first or second trimester of pregnancy and often co-occurs with intellectual disability, psychiatric illness, neuroinflammation and/or gastrointestinal disease.

According to GlobalData, the number of people diagnosed with autism in 16 major pharmaceutical markets around the world in 2023 will reach 9.81 million, and the market is flooded with generic drugs. Currently, only two drugs have been approved by the FDA, namely Risperdal (risperidone) from Johnson & Johnson Innovative Medicine and Abilify (aripiprazole) from Otsuka Pharmaceutical. Both drugs are used to treat autism-related irritability.

In fact, there are very limited safe and effective treatment options for people with autism. Currently, the two approved treatments are atypical antipsychotics, both of which are accompanied by frequent adverse side effects and poor tolerability and patient compliance.

Studies have found that medical marijuana treatment can alleviate clinical symptoms in patients with autism. Cannabis-responsive biomarkers are metabolites found in saliva that change with medical marijuana treatment. The Ajna BioSciences team found that in children with autism who were successfully treated with medical cannabis, the levels of these biomarkers shifted toward physiological levels detected in typically developing children, and it may be possible to quantify this effect.

Joel Stanley, CEO of Ajna BioSciences and chairman of DeFloria, said in a recent interview with Clinical Leader that the trial is about to begin.

"The filing of an IND application and the initiation of a Phase II clinical trial for AJA001 in the United States marks a historic moment in our commitment to developing a systemically absorbed botanical drug therapy that complies with the FDA's advanced clinical trial guidance. Once we complete this round of financing, we will enter Phase II trials, and it will take about 14 to 16 months to get results. At that time, we will begin to seek future commercialization partners and find the right way to fund a larger Phase 3 clinical trial."

According to the established timeline, DeFloria expects its Phase 3 clinical trial to begin next year and obtain final FDA approval in 2030. If approved, AJA001 will become the first FDA-approved full-spectrum CBD botanical in history and only the fifth botanical to do so, joining Jazz Pharmaceuticals' \$1 billion Epidiolex, which was approved by the FDA in 2018 for the treatment of a rare form of epilepsy.

Stanley said Epidiolex is a pure CBD drug, which is completely different from our new drug AJA001, and Epidiolex is produced by a British pharmaceutical company, which makes the FDA approval process much easier and faster than that of domestic cannabis drug companies in the United States. Because for American companies, the US Drug Enforcement Administration did not consider CBD a drug until 2019. Now, with the milestone of the Phase 2 clinical trial, we are one step closer to providing a potential treatment for patients with autism.

It is reported that in addition to the Phase 2 clinical trial in the United States, DeFloria also plans to launch a Phase 2 open-label pediatric study of AJA001 in Australia in 2025.

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