#United States #DeFloria #AJA001 #Autism Spectrum Disorder #Littleton, Colorado

DeFloria's Advances in Autism Treatment: AJA001 Phase 1 Results

DeFloria, a collaboration between Ajna BioSciences and Charlotte's Web, recently unveiled exciting findings from its Phase 1 trials of AJA001, a novel treatment aimed at addressing symptoms associated with Autism Spectrum Disorder (ASD). Presented at the 63rd Annual Meeting of the American College of Neuropsychopharmacology, these results mark a significant step in the ongoing quest for effective treatments for ASD.

Trial Overview

The Phase 1 trial comprised both single and multiple ascending dose studies, designed to evaluate the safety, tolerability, and pharmacokinetics of AJA001 among 70 healthy participants aged 19 to 55. By assessing AJA001's impact, the study aimed to establish a therapeutic profile that could inform future clinical trials for individuals diagnosed with ASD.

Safety and Tolerability Findings

Results indicated that AJA001 was well-tolerated at doses as high as 680 mg per day for single doses and 660 mg per day for divided doses. The pharmacokinetics demonstrated that AJA001 achieved plasma levels similar to, or exceeding, existing cannabinoid treatments such as dronabinol and Epidiolex. This finding suggests not only the drug's potential efficacy but also establishes a favorable safety profile crucial for further development.

The trial reported common side effects including somnolence, anxiety, dizziness, and headaches, with one participant experiencing a serious adverse event that resolved quickly. These results provide a foundation for developing AJA001 for ASD, showcasing its potential for broad therapeutic applications.

Therapeutic Effects

The pharmacodynamics of AJA001 showed a dose-dependent relationship tied to peak plasma concentrations of THC and its active metabolite, 11-OH-THC. Further analysis of participant feedback via the Drug Effects Questionnaire indicated that the perceived drug effects were moderate and transient, an encouraging sign for future use in a pediatric and adolescent population with ASD.

Dr. Marcel O. Bonn-Miller, the Chief Scientific Officer at Charlotte's Web and a board member at DeFloria, expressed optimism over these preliminary findings. According to Dr. Bonn-Miller, the data laid down during this phase would guide the dosing parameters in upcoming Phase 2 trials targeting children, adolescents, and adults diagnosed with ASD.

Future Directions

Echoing this sentiment, Jared Stanley, CEO of DeFloria, expressed excitement about launching two Phase 2 trials for AJA001 in the coming year, highlighting that ASD remains a challenging condition to treat with currently available options. The commitment to developing AJA001 revolves around enhancing patient compliance through a drug formulation that provides greater acceptability and a favorable side effect profile.

Understanding Autism Spectrum Disorder (ASD)

ASD is a complex neurodevelopmental disorder that affects approximately 1 in 36 children, characterized by difficulties in communication, social interaction, and repetitive patterns of behavior. The high prevalence and associated caregiver burdens emphasize the urgent need for improved therapeutic options.

About AJA001

AJA001 is positioned as a botanical drug product, utilizing full-spectrum hemp extract from the CW1AS1 hemp variant. Its multi-cannabinoid formulation aims to harness therapeutic potential across various applications, representing a new frontier in the treatment of disorders like ASD.

Conclusion

The promising outcomes from DeFloria’s Phase 1 trials for AJA001 signal a potential breakthrough in ASD treatment options. With plans for further clinical studies, the hope is that AJA001 can translate into a viable therapeutic option that not only addresses the symptoms of ASD but also enhances the quality of life for those affected. As research continues, the ASD community watches closely for the next steps in this innovative journey.

For further details, you can view the poster presented at the conference at DeFloria's official website.