DeFloria LLC, a collaboration between Charlottes Web Holdings Inc CWBHF and AJNA BioSciences PBC, has launched the Phase 1 clinical trial of AJA001, a full-spectrum hemp botanical drug.
The trial, which marks the first human testing of this innovative substance, began with dosing its first cohort in September and aims to evaluate its safety, tolerability and pharmacokinetic properties.
Details Of The AJA001 Clinical Trial
AJA001, derived from one of Charlotte’s Web’s patented hemp cultivars is expected to enroll approximately 64 participants in Brisbane, Australia. The study will explore both single ascending doses and a seven-day multiple ascending dose phase.
Expert Insights
“Our phase 1 entrance marks a critical milestone in AJA001’s clinical timeline and advances a full-spectrum cannabinoid formulation into rigorous clinical trials that are essential to advance medical science. We are proud of our team’s hard work reaching this point, and I am excited to help develop the Phase 2 program for this new drug,” said Dr. Orrin Devinsky, chief medical advisor at AJNA Biosciences.
Dr. Marcel Bonn-Miller Ph.D., chief scientific officer at Charlotte’s Web explained further. “The initiation of the AJA001 clinical program serves as an important milestone for DeFloria. Data from this study will help us better understand the safety profile of AJA001 and position us to move into Phase 2 studies with greater dosing accuracy.”
Joel Stanley, co-founder of AJNA BioSciences, praised the achievement as a testament to the team’s commitment and expertise. Following this Phase 1 study, DeFloria plans to submit an Investigational New Drug application to the FDA for Phase 2 trials.
FDA’s Botanical Drug Pathway
AJA001 is developed through the FDA’s botanical drug pathway, which facilitates the development of such innovative treatments, ensuring they meet the same rigorous standards as conventional pharmaceuticals.
CWBHF Price Action
CWBHF's shares were trading 5.95% higher at $0.2225 per share at the time of this writing around 11:00 AM ET Wednesday.
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