Phase 1 Results to Inform Phase 2 studies in 1H24
DENVER, Dec. 13,
2023 /PRNewswire/ - (TSX: CWEB) (OTCQX: CWBHF),
Charlotte's Web Holdings, Inc. ("Charlotte's Web," "CW" or the
"Company"), the market leader in full-spectrum hemp extract
wellness products, and AJNA BioSciences PBC ("AJNA"), a botanical
drug development company focused on mental health and neurological
disorders, announced today that DeFloria LLC ("DeFloria") commenced
its First-in-Human Phase 1 clinical trial for AJA001, a
full-spectrum botanical drug.
Dr. Orrin Devinsky Ph.D., the Chief Medical Advisor at AJNA
Biosciences stated, "Our phase 1 entrance marks a
critical milestone in AJA001's clinical timeline and advances a
full-spectrum cannabinoid formulation into rigorous clinical trials
that are essential to advance medical science. We are proud of our
team's hard work reach this point, and I am excited to help develop
the Phase 2 program for this new drug."
AJA001's initial research is dedicated to the examination
of the safety, tolerability, pharmacokinetics, and pharmacodynamics
in fasted and fed healthy participants of a full spectrum hemp oil
extracted from one of Charlotte's Web's patented hemp cultivars
("AJA-001"). The study includes single ascending dose and a
seven-day multiple ascending dose administration phases. The study
is expected to involve around 64 participants. The first cohort was
dosed in early September and Defloria expects preliminary results
in the first quarter of 2024. The study is being conducted with
Nucleus Networks in Brisbane,
Australia.
"The initiation of the AJA001 clinical program serves as an
important milestone for DeFloria. Data from this study will help us
better understand the safety profile of AJA001 and position us to
move into Phase 2 studies with greater dosing accuracy,"
remarked Dr. Marcel Bonn-Miller Ph.D., Chief Scientific Officer
at Charlotte's Web.
AJA001, an investigational full-spectrum cannabinoid drug,
leverages Charlotte's Web's proprietary hemp genetics. As an
innovative multi-cannabinoid formulation, it may provide a more
complete therapeutic action relative to single-molecule
alternatives. Its full-spectrum composition has potential
therapeutic applications across various medical conditions due to
its varied mechanisms of action.
"This achievement shows the commitment and excellence of our
top-tier team. At DeFloria, we have united the early leaders in CBD
with the finest minds in clinical and biotechnological research.
This milestone is a big one for early adopters in botanical drug
development, and especially for those of us that have known
cannabinoid therapies would become very important in modern
medicine. As we approach Phase 2 efficacy trials in the new year,
DeFloria is establishing itself as a key player and leader in the
new field of botanical drugs," noted Joel Stanley, Co-Founder of AJNA
BioSciences."
Following completion of this Phase 1 study, DeFloria plans to
submit an Investigational New Drug (IND) application to the Food
and Drug Administration (FDA) to commence the Phase 2 clinical
program for AJA001. AJA001 is being developed through the FDA's
botanical drug pathway, which serves as a specialized regulatory
framework, streamlining the development and approval of
pharmaceutical products derived from plants or plant-based
substances, acknowledging their unique properties. This approach
aims to strike a balance between harnessing existing knowledge
about botanicals and ensuring that these products adhere to the
same stringent quality, safety, and efficacy standards as
conventional pharmaceuticals.
About DeFloria LLC
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. Visit www.defloria.bio
About AJNA BioSciences PBC
AJNA BioSciences PBC is a
botanical drug development company based in Denver, Colorado, focused on natural
pharmaceuticals that address mental health and neurological
disorders. The Company's strategy encompasses selecting plant and
fungi species with a well-established history of therapeutic use,
which streamlines drug discovery, mitigates late-stage clinical
trial risk, to advance unprecedented medicinal breakthroughs.
AJNA's unique platform is designed for rapid development of
investigational new drugs by combining specialized laboratory
infrastructure and CMC capabilities with top-tier clinical and
regulatory expertise. AJNA's commercialization strategy is
flexibly designed for co-development partnerships, IP licensing,
and vertically integrated drug products in a broad range of
botanical species and clinical indications. As a public benefit
corporation, AJNA's business model maximizes profitability and
sustainability for both people and the planet. Visit
www.AjnaBiosciences.com
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 under a
family of brands that includes Charlotte's Web™, ReCreate™, CBD
Medic™, and CBD Clinic™. Charlotte's Web whole-plant CBD extracts
come in full-spectrum and broad-spectrum options, including
ReCreate™ by Charlotte's Web, broad-spectrum CBD certified NSF for
Sport®. ReCreate is the official CBD of Major League
Baseball©, Angel City Football Club and the Premier Lacrosse
League. 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"), 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), 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 health
care practitioners throughout the U.S.A, and online through the Company's
website at www.charlottesweb.com.
© 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. 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. Specifically,
this news release contains forward-looking
statements relating to, among others,
the ability
of DeFloria to achieve its purpose,
including obtaining FDA approval of a new
CBD-based botanical drug.
The material factors and assumptions used to develop the
forward-looking statements herein include, but are not limited to:
regulatory regime change and including but not limited to 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, 2022 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.
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SOURCE Charlotte's Web Holdings, Inc.