Charlotte's Web Moves to Phase 2 FDA Trial for Autism Treatment with DeFloria

Charlotte's Web Advances DeFloria to Phase 2 Clinical Trial for Autism Treatment

Charlotte's Web Holdings, Inc., recognized as a leader in producing hemp extract wellness products, has recently announced a significant milestone in its research and development process. The company is moving forward with DeFloria, Inc. into the Phase 2 clinical trial of its AJA001 Oral Solution, a potential treatment aimed at alleviating symptoms associated with Autism Spectrum Disorder (ASD). This advancement follows the completion of the FDA's review of Phase 1 data and the Investigational New Drug (IND) application.

Bill Morachnick, CEO of Charlotte's Web, emphasized the importance of this progress, stating, "Advancing to Phase 2 of an IND study with the FDA marks an important milestone in the development of our proprietary hemp genetics as regulated medicine." The pharmaceutical candidate AJA001 is established on a foundation of Charlotte's Web's unique full-spectrum CBD hemp extract, derived from patented hemp cultivars cultivated using innovative methods honed over a decade.

The collaboration between Charlotte's Web and Ajna BioSciences PBC, the botanical drug development firm behind the AJA001 project, highlights their commitment to develop effective therapies for conditions like ASD that lack sufficient treatment options. The focus of this Phase 2 clinical trial will be on evaluating the safety, tolerability, and efficacy of AJA001 among the target demographic of adolescents and adults with ASD. These studies will build upon the encouraging results obtained during the preceding Phase 1 trials.

Dr. Marcel Bonn-Miller, Chief Scientific Officer at Charlotte's Web, described the advancement as a landmark moment for botanical drug development. "Charlotte's Web has aimed to meet the needs of those underserved by current therapies for the past decade," he said. AJA001's journey through the FDA's botanical drug pathway reflects the extensive therapeutic potential of hemp extracts. The ongoing research strongly supports the idea that cannabinoids could serve as viable treatment options for irritability in autism cases, underscoring the urgency for effective alternatives in this space.

The Phase 2 clinical trial will provide critical data that will inform the structuring of larger Phase 3 clinical trials, which are necessary for drug approval by the FDA. The results from this round will pave the way for AJA001’s potential impact in the medical market, particularly in providing relief for millions of families affected by autism.

Charlotte's Web, headquartered in Louisville, Colorado, is notable as a Certified B Corporation, committed to transparency and high-quality production practices. Their natural products, deeply rooted in the innovative utilization of whole-plant extracts, promise not only efficacy but also the potential to rewrite the narrative around cannabinoids and their therapeutic properties.

As the industry continues to evolve, Charlotte's Web stands at the forefront, ready to lead the charge towards enhanced healthcare solutions through responsible and sustainable hemp-derived products. The company aims not only to solidify its place in the consumer wellness sector but also to branch out into more regulated medical markets, emphasizing the broader applicability of their advanced hemp research.

In summary, the FDA's approval for DeFloria to move into Phase 2 signifies a promising step towards developing a much-needed treatment for autism spectrum disorder, a field that has long awaited innovative and effective solutions. As they embark on this journey, Charlotte's Web and DeFloria are set to potentially transform the lives of those battling the challenges posed by ASD.