180 Life Sciences Corp. (NASDAQ: ATNF) (“180LS” or the “Company”),
today announced the filing of a provisional patent describing the
novel combination of CBD, or an analog thereof, with glucagon
related peptide-1 (GLP-1) agonists to address the problem of
obesity and weight management. Co-administration of Cannabidiol
(CBD), a known appetite suppressant and antiemetic, might be
expected both to limit the deleterious side effects and lower the
effective dosage of the GLP-1 agonists.
CBD has been shown to reduce inflammation and
stimulate satiety, but establishing the details of the mode of
action has been hampered by CBD binding over 50 different
biological receptors. Consequently, we believe the scientific
community has assumed the clinical benefits arise from a summation
of weak stimulations of a spectrum of molecular pathways, rather
than a single, critical biological signal. However, the recent
clinical success of GLP-1 agonists in stimulating satiety and
resultant weight reduction in patients with type 2 diabetes led
180LS scientists to hypothesize that CBD and GLP-1 might stimulate
a common therapeutic pathway. The dramatically different structures
of the two drugs make binding a common receptor unlikely, but we
speculate that the two compounds could stimulate a common
neurological pathway between the gut and the brain. GLP-1 signals
satiety to the brain through stimulation of specific GLP-1
receptors expressed on the afferent arm of the vagus nerve.
Scientists at 180 Life Sciences plan to collaborate with
neurological experts to investigate whether cannabidiol (CBD)
stimulates satiety through a neural pathway involving the vagus
nerve. Negotiations are currently underway with third party
scientists for a research collaboration to design and execute
testing of our theory as described following, of which there can be
no assurance.
This research collaboration is designed to
determine whether CBD and GLP-1 stimulate a common signal for
satiety to the brain. If so, CBD may represent a significantly less
expensive alternative with fewer side effects than GLP-1 agonists
for weight reduction. 180LS has licensed patents, based on the work
of the late Dr. Mechoulam, (a pioneer of CBD chemistry at Hebrew
University in Israel), that describe novel synthetic CBD compounds
which could induce appetite suppression and be therapeutic for
obesity and weight management.
“We are excited about the opportunity to
collaborate with scientists who are experts in vagus nerve
signaling,” said Dr. James Woody, CEO of 180 Life Sciences Corp.,
who continued, “We expect, if the hypothesis is correct, this
research could provide support to proceed to human clinical trials.
Our Chief Scientific Officer, Dr. Jonathan Rothbard, was involved
in the Amylin discovery work of the GLP-1 pathway and has extensive
scientific knowledge of how synthetic CBD compounds might induce
satiety through stimulating the vagus nerve.”
About 180 Life Sciences Corp.
180 Life Sciences Corp. is a clinical-stage
biotechnology company driving ground-breaking studies into clinical
programs which are seeking to address major unmet medical needs.
The Company’s focus is a novel program to treat several
inflammatory disorders using anti-TNF (tumor necrosis factor)
biologics. In addition, the Company is exploring the
anti-inflammatory and analgesic properties of synthetic CBD
compounds, that also might be effective in appetite
suppression.
Forward-Looking Statements
This press release includes “forward-looking
statements”, including information about management’s view of the
Company’s future expectations, plans and prospects, within the safe
harbor provisions provided under federal securities laws, including
under The Private Securities Litigation Reform Act of 1995 (the
“Act”). Words such as “expect,” “estimate,” “project,” “budget,”
“forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,”
“should,” “believes,” “predicts,” “potential,” “continue” and
similar expressions are intended to identify such forward-looking
statements. These forward-looking statements involve significant
risks and uncertainties that could cause the actual results to
differ materially from the expected results and, consequently, you
should not rely on these forward-looking statements as predictions
of future events. These forward-looking statements and factors that
may cause such differences include, without limitation, risks
regarding the outcome of the PK study discussed above, the timing
and costs thereof, and the ability to obtain sufficient
participants; our ability to commercialize PNL, if proven
successful for treatment in trials; risks regarding whether the
administrative processes required for the issuance of patents will
be completed in a timely manner or at all, whether patents, if
issued, will provide sufficient protection and market exclusivity
for the Company, whether any patents held by the Company may be
challenged, invalidated, infringed or circumvented by third
parties; events that could interfere with the continued validity or
enforceability of a patent; the Company’s ability generally to
maintain adequate patent protection and successfully enforce patent
claims against third parties; the timing of, outcome of, and
results of, clinical trials statements regarding the timing of our
planned marketing authorization application (MAA) submission to the
UK Medicines and Healthcare products Regulatory Agency (MHRA), our
ability to obtain approval and acceptance thereof, the willingness
of MHRA to review such MAA, and our ability to address outstanding
comments and questions from the MHRA; statements about the ability
of our clinical trials to demonstrate safety and efficacy of our
product candidates, and other positive results; the uncertainties
associated with the clinical development and regulatory approval of
180 Life Sciences’ drug candidates, including potential delays in
the enrollment and completion of clinical trials, closures of such
trials prior to enrolling sufficient participants in connection
therewith, issues raised by the U.S. Food and Drug Administration
(FDA), the MHRA and the European Medicines Agency (EMA); the
ability of the Company to persuade regulators that chosen endpoints
do not require further validation; timing to complete required
studies and trials, and timing to obtain governmental approvals;
the accuracy of simulations and the ability to reproduce the
outcome of such simulations in real world trials; 180 Life
Sciences’ reliance on third parties to conduct its clinical trials,
enroll patients, and manufacture its preclinical and clinical drug
supplies; the ability to come to mutually agreeable terms with such
third parties and partners, and the terms of such agreements;
estimates of patient populations for 180 Life Sciences planned
products; unexpected adverse side effects or inadequate therapeutic
efficacy of drug candidates that could limit approval and/or
commercialization, or that could result in recalls or product
liability claims; 180 Life Sciences’ ability to fully comply with
numerous federal, state and local laws and regulatory requirements,
as well as rules and regulations outside the United States, that
apply to its product development activities; the timing of filing,
the timing of governmental review, and outcome of, planned
Investigational New Drug (IND) applications for drug candidates;
current negative operating cash flows and a need for additional
funding to finance our operating plans; the terms of any further
financing, which may be highly dilutive and may include onerous
terms, increases in interest rates which may make borrowing more
expensive and increased inflation which may negatively affect
costs, expenses and returns; statements relating to expectations
regarding future agreements relating to the supply of materials and
license and commercialization of products; the availability and
cost of materials required for trials; the risk that initial drug
results are not predictive of future results or will not be able to
be replicated in clinical trials or that such drugs selected for
clinical development will not be successful; challenges and
uncertainties inherent in product research and development,
including the uncertainty of clinical success and of obtaining
regulatory approvals; uncertainty of commercial success; the
inherent risks in early stage drug development including
demonstrating efficacy; development time/cost and the regulatory
approval process; the progress of our clinical trials; our ability
to find and enter into agreements with potential partners; our
ability to attract and retain key personnel; changing market and
economic conditions; our ability to produce acceptable batches of
future products in sufficient quantities; unexpected manufacturing
defects; manufacturing difficulties and delays; competition,
including technological advances, new products and patents attained
by competitors; challenges to patents; product efficacy or safety
concerns resulting in product recalls or regulatory action; changes
in behavior and spending patterns of purchasers of health care
products and services; changes to applicable laws and regulations,
including global health care reforms; expectations with respect to
future performance, growth and anticipated acquisitions; the
continued listing of the Company’s securities on The NASDAQ Stock
Market; expectations regarding the capitalization, resources and
ownership structure of the Company; expectations with respect to
future performance, growth and anticipated acquisitions; the
ability of the Company to execute its plans to develop and market
new drug products and the timing and costs of these development
programs; estimates of the size of the markets for its potential
drug products; the outcome of current litigation involving the
Company; potential future litigation involving the Company or the
validity or enforceability of the intellectual property of the
Company; global economic conditions; geopolitical events and
regulatory changes; the expectations, development plans and
anticipated timelines for the Company’s drug candidates, pipeline
and programs, including collaborations with third parties; access
to additional financing, and the potential lack of such financing;
and the Company’s ability to raise funding in the future and the
terms of such funding; and the effect of rising interest rates and
inflation, and economic downturns and recessions. These risk
factors and others are included from time to time in documents the
Company files with the Securities and Exchange Commission,
including, but not limited to, its Form 10-Ks, Form 10-Qs and Form
8-Ks, and including the Annual Report on Form 10-K for the year
ended December 31, 2022, and Quarterly Report on Form 10-Q for the
quarter ended March 31, 2023, and future SEC filings. These reports
and filings are available at www.sec.gov and are available for
download, free of charge, soon after such reports are filed with or
furnished to the SEC, on the “Investors”, “SEC Filings”, “All SEC
Filings” page of our website at www.180lifesciences.com. All
subsequent written and oral forward-looking statements concerning
the Company, the results of the Company’s clinical trial results
and studies or other matters and attributable to the Company or any
person acting on its behalf are expressly qualified in their
entirety by the cautionary statements above. Readers are cautioned
not to place undue reliance upon any forward-looking statements,
which speak only as of the date made, including the forward-looking
statements included in this press release, which are made only as
of the date hereof. The Company cannot guarantee future results,
levels of activity, performance or achievements. Accordingly, you
should not place undue reliance on these forward-looking
statements. The Company does not undertake or accept any obligation
or undertaking to release publicly any updates or revisions to any
forward-looking statement to reflect any change in its expectations
or any change in events, conditions, or circumstances on which any
such statement is based, except as otherwise provided by law.
Investors:
Jason AssadDirector of IR180 Life Sciences
Corp.Jassad@180lifesciences.com
180 Life Sciences (NASDAQ:ATNF)
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