Promising Findings Presented at the American College of Neuropsychopharmacology Annual Meeting
LOUISVILLE, Colo., Dec. 12, 2024 /PRNewswire/ - (TSX: CWEB) (OTCQX: CWBHF) Charlotte's Web Holdings, Inc. ("Charlotte's Web" or the "Company") the market leader in cannabidiol (CBD) hemp extract wellness products, is pleased to share an update on the progress of DeFloria LLC's ("DeFloria") botanical pharmaceutical development, an entity established by AJNA BioSciences and Charlotte's Web. Promising findings from DeFloria's Phase 1 clinical trial results for AJA001 were presented by Dr. Marcel Bonn-Miller at the American College of Neuropsychopharmacology Annual Meeting on December 11, 2024. AJA001 is being developed for the treatment of symptoms of autism spectrum disorder (ASD).
AJA001 Oral Solution is being developed by DeFloria as an innovative new botanical drug containing a multi-compound hemp extract with a full spectrum of cannabinoids, bridging the gap between natural wellness products and FDA-regulated medicines that are generally single-compound drugs. Leveraging a proprietary hemp cultivar patented by Charlotte's Web, the Phase 1 trial, designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AJA001, demonstrated that the investigational drug was well-tolerated across a wide dose range. The study provides critical data for determining appropriate dosing protocols that will be used in Phase 2 trials.
Strategic Alignment with Charlotte's Web's Vision
As a co-founder of DeFloria, Charlotte's Web is proud to see its proprietary hemp genetics being utilized to advance innovative therapies for underserved health conditions, such as ASD. The multi-cannabinoid composition of AJA001 underscores the potential of botanical drug development, paving a new category of solutions that provide broad therapeutic efficacy.
"DeFloria's Phase 1 findings represent a significant step toward integrating botanical hemp-based therapies into modern pharmaceutical medicine," said Dr. Marcel Bonn-Miller, Chief Scientific Officer at Charlotte's Web and DeFloria Board Member. "AJA001 isn't just a standalone initiative; it continues Charlotte's Web's long-standing mission grounded in addressing the diverse needs of individuals and families. The safety and pharmacokinetic data from this trial affirm AJA001's potential particularly in a space with limited treatment options. These positive Phase 1 results bring us closer to creating real solutions for this underserved community."
Expanding Charlotte's Web's Leadership in Botanical Science
"DeFloria's Phase 1 results validate our strategic vision of advancing botanical science through pharmaceutical pathways," said Bill Morachnick, CEO of Charlotte's Web. "This milestone demonstrates how our proprietary genetics and expertise in hemp cultivation can create significant value beyond our core wellness business, potentially opening new markets and revenue opportunities for our shareholders."
Clinical and Commercial Opportunities
DeFloria is preparing to submit the Phase 1 trial data as part of its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for review. If the FDA raises no objections, DeFloria plans to advance to Phase 2 clinical trials.
DeFloria's planned Phase 2 trials in ASD will explore the therapeutic potential of AJA001 in addressing behavioral symptoms and improving quality of life for individuals with the condition. These trials represent a significant step toward potential FDA approval, which would pave the way for broader access to this groundbreaking therapy.
Charlotte's Web continues to prioritize its focus on quality, transparency, and innovation, positioning itself to capitalize on emerging opportunities in regulated botanical drug markets. The progress with DeFloria aligns with the Company's long-term strategy to enhance shareholder value through diversified growth initiatives.
About DeFloria DeFloria LLC, a collaboration between Charlotte's Web, Inc., AJNA BioSciences PBC, and British American Tobacco PLC (BAT), is on a mission to address crucial healthcare needs through groundbreaking innovations from multi-compound drugs originating in nature. With a combined century of experience in regulatory, research, and quality-controlled standardized manufacturing, DeFloria's ambitious endeavor aims to secure FDA approval for a novel cutting-edge botanical drug developed from Charlotte's Web proprietary hemp genetics that targets a neurological condition identified by the DeFloria leadership and research teams.
Certain information provided herein constitutes forward-looking statements or information (collectively, "forward-looking statements") within the meaning of applicable securities laws. Forward-looking statements are typically identified by words such as "may", "will", "should", "could", "anticipate", "expect", "project", "estimate", "forecast", "plan", "intend", "target", "believe" and similar words suggesting future outcomes or statements regarding an outlook. Forward-looking statements are not guarantees of future performance and readers are cautioned against placing undue reliance on forward-looking statements. This press release includes forward-looking statements. By their nature, these statements involve a variety of assumptions, known and unknown risks and uncertainties, and other factors which may cause actual results, levels of activity, and achievements to differ materially from those expressed or implied by such statements. The forward-looking statements contained in this press release are based on certain assumptions and analysis by management of the Company in light of its experience and perception of historical trends, current conditions and expected future development and other factors that it believes are appropriate and reasonable.
The material factors and assumptions used to develop the forward-looking statements herein include material risk factors that could cause actual results to differ materially from the forward-looking statements including, among others, general economic and market risks, cyber-security risks and those risks and uncertainties discussed under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ending December 31, 2023, and other risk factors contained in other filings with the Securities and Exchange Commission available on www.sec.gov and filings with Canadian securities regulatory authorities available on www.sedarplus.ca. The impact of any one risk, uncertainty, or factor on a particular forward-looking statement is not determinable with certainty as these are interdependent, and the Company's future course of action depends on management's assessment of all information available at the relevant time.
Any forward-looking statement in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. Except as required by applicable law, the Company assumes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. All forward-looking statements, whether written or oral, attributable to the Company or persons acting on the Company's behalf, are expressly qualified in their entirety by these cautionary statements.
