LOUISVILLE, Colo.,
Feb. 24,
2025 /PRNewswire/ - (TSX: CWEB) (OTCQX: CWBHF)
Charlotte's Web Holdings, Inc. ("Charlotte's Web" or the
"Company"), 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
Investigational New Drug (IND) application submitted by DeFloria,
Inc. ("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).
"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," said Bill Morachnick, Chief Executive Officer of
Charlotte's Web. "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."
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 drug.
"Advancing AJA001 to Phase 2 is a landmark moment for
botanical drug development," stated Dr. Marcel Bonn-Miller, Chief Scientific Officer at
Charlotte's Web and DeFloria Board Member. "Charlotte's Web
has aimed to meet the needs of those underserved by current
therapies for the past decade. AJA001's journey through the FDA's
botanical drug pathway showcases the wide therapeutical potential
of hemp. We feel this research strongly supports cannabinoids as a
viable therapy for irritability associated with autism spectrum
disorder, which currently lacks adequate treatment options.
DeFloria is at the cutting edge with AJA001, and we are eager for
DeFloria to begin Phase 2 of development."
DeFloria's planned Phase 2 clinical trial will evaluate the
safety, tolerability, and effectiveness of AJA001 among adolescents
and adults with ASD, building on the promising results from Phase
1. Data from Phase 2 studies will be used to inform the design of
larger Phase 3 clinical trials, the results from which will be
submitted to FDA for drug approval.
For more information see today's announcement from DeFloria:
https://www.prnewswire.com/news-releases/defloria-receives-investigational-new-drug-application-clearance-from-fda-for-phase-2-clinical-trial-of-aja001-an-oral-cannabinoid-drug-being-developed-for-the-treatment-of-autism-spectrum-disorder-asd-302382573.html
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About Charlotte's Web Holdings, Inc.
Charlotte's Web
Holdings, Inc., a Certified B Corporation headquartered in
Louisville, Colorado, is the
market leader in innovative hemp extract wellness products that
include Charlotte's Web whole-plant full-spectrum CBD extracts as
well as broad-spectrum CBD certified NSF for Sport®. Charlotte's
Web branded premium quality products start with proprietary hemp
genetics that are North American farm-grown using organic and
regenerative cultivation practices. The Company's hemp extracts
have naturally occurring botanical compounds including cannabidiol
("CBD"), CBN, CBC, CBG, terpenes, flavonoids, and other beneficial
compounds. Charlotte's Web product categories include CBD oil
tinctures (liquid products), CBD gummies (sleep, calming, exercise
recovery, immunity), CBN gummies, functional mushroom gummies, CBD
capsules, CBD topical creams, and lotions, as well as CBD pet
products for dogs. Through its substantially vertically integrated
business model, Charlotte's Web maintains stringent control over
product quality and consistency with analytic testing from soil to
shelf for quality assurance. Charlotte's Web products are
distributed to retailers and healthcare practitioners throughout
the U.S.A. and online through the
Company's website at http://www.charlottesweb.com.
Charlotte's Web is the official CBD of Major League
Baseball©.
© Major League Baseball trademarks and copyrights are used with
permission of Major League Baseball. Visit MLB.com.
Forward-Looking Information
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
including: the future performance or achievements of DeFloria,
Inc., future dose trial results, therapeutic efficacy, or approvals
of AJA001 Oral Solution the results of which may be materially
different from those expressed or implied by the forward-looking
statements contained in this press release.
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 other
forward-looking information herein include factors discussed
throughout the "Risk Factors" section of the Company's most
recently filed annual information form available on
www.SEDARplus.ca and in the Company's most recently filed Annual
Report on Form 10-K and quarterly report on Form 10-Q as amended,
and other filings with the Securities and Exchange Commission
available on www.SEC.gov. Except as required by applicable
securities laws, the Company undertakes no obligation to publicly
update any forward-looking information, whether written or oral,
that may be made from time to time, whether as a result of new
information, future developments or otherwise.
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SOURCE Charlotte's Web Holdings, Inc.
