Charlotte's Web Provides Update on DeFloria's Phase 1 Results Targeting Autism Spectrum Disorder
Charlotte's Web Holdings (TSX: CWEB) (OTCQX: CWBHF) announced updates on DeFloria 's Phase 1 clinical trial results for AJA001, a treatment targeting autism spectrum disorder (ASD) symptoms. The findings, presented by Dr. Marcel Bonn-Miller at the American College of Neuropsychopharmacology Annual Meeting on December 11, 2024, were described as promising. DeFloria is a joint venture between AJNA BioSciences and Charlotte's Web, focusing on botanical pharmaceutical development.
Charlotte's Web Holdings (TSX: CWEB) (OTCQX: CWBHF) ha annunciato aggiornamenti sui risultati della fase 1 della sperimentazione clinica di DeFloria per AJA001, un trattamento mirato ai sintomi del disturbo dello spettro autistico (ASD). I risultati, presentati dal Dr. Marcel Bonn-Miller al Meeting Annuale del Collegio Americano di Neuropsicofarmacologia il 11 dicembre 2024, sono stati descritti come promettenti. DeFloria è una joint venture tra AJNA BioSciences e Charlotte's Web, focalizzata sullo sviluppo di prodotti farmaceutici botanici.
Charlotte's Web Holdings (TSX: CWEB) (OTCQX: CWBHF) anunció actualizaciones sobre los resultados de la fase 1 del ensayo clínico de DeFloria para AJA001, un tratamiento dirigido a los síntomas del trastorno del espectro autista (ASD). Los hallazgos, presentados por el Dr. Marcel Bonn-Miller en la Reunión Anual del Colegio Americano de Neuropsicofarmacología el 11 de diciembre de 2024, fueron descritos como prometedores. DeFloria es una empresa conjunta entre AJNA BioSciences y Charlotte's Web, centrada en el desarrollo de productos farmacéuticos botánicos.
Charlotte's Web Holdings (TSX: CWEB) (OTCQX: CWBHF)는 AJA001의 DeFloria 1상 임상 시험 결과에 대한 업데이트를 발표했습니다. 이는 자폐 스펙트럼 장애(ASD) 증상을 겨냥한 치료제입니다. 결과는 2024년 12월 11일 미국 신경심리약리학회 연례 회의에서 마르셀 본-밀러 박사에 의해 발표되었으며, 유망하다고 설명되었습니다. DeFloria는 AJNA BioSciences와 Charlotte's Web 간의 합작 투자로, 식물 의약품 개발에 중점을 두고 있습니다.
Charlotte's Web Holdings (TSX: CWEB) (OTCQX: CWBHF) a annoncé des mises à jour sur les résultats de l'essai clinique de phase 1 de DeFloria pour AJA001, un traitement visant les symptômes du trouble du spectre autistique (TSA). Les résultats, présentés par le Dr. Marcel Bonn-Miller lors de la Réunion Annuelle du Collège Américain de Neuropsychopharmacologie le 11 décembre 2024, ont été décrits comme prometteurs. DeFloria est une coentreprise entre AJNA BioSciences et Charlotte's Web, axée sur le développement de médicaments botaniques.
Charlotte's Web Holdings (TSX: CWEB) (OTCQX: CWBHF) hat Aktualisierungen zu den Ergebnissen der Phase 1 der klinischen Studie von DeFloria für AJA001 angekündigt, einer Behandlung, die auf die Symptome von Autismus-Spektrum-Störungen (ASD) abzielt. Die Ergebnisse, die von Dr. Marcel Bonn-Miller auf der Jahrestagung des American College of Neuropsychopharmacology am 11. Dezember 2024 vorgestellt wurden, wurden als vielversprechend beschrieben. DeFloria ist ein Joint Venture zwischen AJNA BioSciences und Charlotte's Web, das sich auf die Entwicklung botanischer Arzneimittel konzentriert.
- Phase 1 clinical trial for ASD treatment shows promising results
- Results presented at a major scientific conference indicating academic validation
- None.
Promising Findings Presented at the American College of Neuropsychopharmacology Annual Meeting
About AJA001 Oral Solution
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
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.
About Charlotte's Web Holdings, Inc.
Charlotte's Web Holdings, Inc., a Certified B Corporation headquartered in
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