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Charlotte's Web Announces DeFloria to enter Phase 2 FDA Clinical Trial for Autism Spectrum Disorder Treatment
Charlotte's Web Announces DeFloria to enter Phase 2 FDA Clinical Trial for Autism Spectrum Disord...
About this update from Charlotte's Web Holdings, Inc.
[{"type":"text","content":"\n\n\n\n Charlotte's Web Announces DeFloria to enter Phase 2 FDA Clinical Trial for Autism Spectrum Disorder Treatment\n \n\n /* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n \n\n\n\n\n\n Canada NewsWire\n \n\n\n\n\n LOUISVILLE, Colo.\n \n ,\n \n\n Feb. 24, 2025\n \n\n /CNW/ - (TSX: CWEB) (OTCQX: CWBHF) Charlotte's Web Holdings, Inc. (\"\n \n Charlotte's Web\n \n \" or the \"\n \n Company\n \n \"), a market leader in hemp extract wellness products, is pleased to announce that the U.S. Food and Drug Administration (FDA) has completed its review of Phase 1 data and\n \n Investigational New Drug (IND) application submitted by DeFloria, Inc.\n \n (\"DeFloria\"). The FDA has concluded that DeFloria may now proceed with its planned FDA Phase 2 clinical trial for its botanical pharmaceutical candidate, AJA001 Oral Solution, a treatment for symptoms of autism spectrum disorder (ASD).\n \n\n\n\n\n\n\n\n\n\n \"Progressing 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,\"\n \n said\n \n\n Bill Morachnick\n \n , Chief Executive Officer of Charlotte's Web.\n \n\n \"By leveraging our deep expertise in hemp cultivation and proprietary formulations, we are reinforcing and extending our leadership in hemp wellness from the consumer sector into the regulated medical sector. A safe and effective botanical treatment for autism spectrum disorder would be a medical asset that could provide immense value to millions of families and Charlotte's Web.\"\n \n\n\n DeFloria is a collaboration including Charlotte's Web and Ajna BioSciences PBC, a botanical drug development company, to develop AJA001 as a treatment for irritability associated with autism spectrum disorder. AJA001 employs Charlotte's Web proprietary full-spectrum cannabidiol (CBD) hemp extract derived from one of its patented cultivars. Drawing on a decade of research, innovation, and rigorous cultivation methods from Charlotte's Web, DeFloria is developing AJA001 with the Company's proprietary hemp genetics as the foundation of the botanical dru...