Charlotte's Web's DeFloria Enters Phase 2 FDA Trial for Autism Treatment

LOUISVILLE, Colo., Feb. 24, 2025 - Charlotte's Web Holdings, Inc., a leader in the hemp extract wellness industry, has announced a significant development involving the U.S. Food and Drug Administration (FDA) and DeFloria, Inc. The FDA has completed its review of the Phase 1 data and Investigational New Drug (IND) application for DeFloria's botanical pharmaceutical candidate, AJA001 Oral Solution, which is intended to treat symptoms associated with autism spectrum disorder (ASD). The FDA's approval enables DeFloria to proceed with a Phase 2 clinical trial, marking a crucial step in the product's development.

Charlotte's Web CEO, Bill Morachnick, expressed the importance of this advancement, highlighting its role in transitioning their proprietary hemp genetics into regulated medicine. The goal is to extend their leadership in hemp wellness from consumer products to the medical sector. AJA001, if proven safe and effective, could provide significant benefits to families affected by autism.

DeFloria, a collaborative venture between Charlotte's Web and Ajna BioSciences PBC, aims to develop AJA001 as a treatment for ASD-related irritability. The product utilizes Charlotte's Web's full-spectrum cannabidiol (CBD) hemp extract, derived from patented hemp cultivars. With over a decade of research and innovation underpinning this development, DeFloria leverages Charlotte's Web's advanced cultivation methods and proprietary hemp genetics.

Dr. Marcel Bonn-Miller, Chief Scientific Officer at Charlotte's Web and a board member of DeFloria, views this progression to Phase 2 as a milestone in botanical drug development. He noted the potential of cannabinoids as a promising therapy for ASD-related symptoms, an area currently underserved by existing treatments. The journey of AJA001 through the FDA's botanical drug pathway exemplifies the wide-ranging therapeutic possibilities of hemp.

The upcoming Phase 2 clinical trial by DeFloria will focus on assessing the safety, tolerability, and effectiveness of AJA001 among adolescents and adults with ASD. This phase will build upon the encouraging results from Phase 1. The data collected will be instrumental in designing larger Phase 3 clinical trials, which are crucial for seeking FDA approval for AJA001.

Charlotte's Web Holdings, Inc., headquartered in Louisville, Colorado, is a Certified B Corporation and a prominent name in the hemp extract wellness product market. Their product line includes whole-plant full-spectrum CBD extracts and broad-spectrum CBD certified NSF for Sport®. These products are developed from proprietary hemp genetics grown in North America using organic and regenerative cultivation practices. The company’s offerings range from CBD oil tinctures and gummies to topical creams and pet products.

By maintaining a vertically integrated business model, Charlotte's Web ensures stringent quality and consistency in its products, from cultivation to retail. The company performs thorough analytic testing to uphold quality assurance. Their products are available to both retailers and healthcare practitioners across the United States and can be purchased online.

Additionally, Charlotte's Web is recognized as the official CBD of Major League Baseball, illustrating the brand's widespread reach and influence in the wellness industry.

Through this partnership with DeFloria, Charlotte's Web continues to demonstrate its commitment to innovation and leadership in the emerging field of hemp-based medical treatments. The progress of AJA001 as a potential treatment for ASD symptoms highlights the evolving role of cannabinoids in providing alternative therapeutic options.