180 Life Sciences Corp. (NASDAQ: ATNF) (“180 Life Sciences” or the
“Company”), today announced topline results from a clinical
pharmacology study (the “Study”), that evaluated the uptake of
cannabidiol (CBD) in a solid formulation which can be delivered as
a pill orally. The clinical trial in humans, performed with Prof.
Avi Domb of the Hebrew University, School of Pharmacy, and with
Prof. Elyad Davidson, of Hadassah Hospital, compared two solid
formulations of CBD with a U.S. Food and Drug Administration (FDA)
approved drug for epilepsy, Epidiolex. The purpose of the Study was
to compare the pharmokinetic (PK) profile of a generic approved CBD
product, Epidiolex®, with two solid formulations. We believe this
type of trial has yet to be examined in a clinical setting. For the
Company’s trial, twelve volunteers received all three formulations
in a crossover randomized trial.
Epidiolex is a CBD dissolved in 8% ethanol and
80% sesame seed oil, plus flavoring agents, that is given as a
liquid solution via syringe in the mouth. Results of the clinical
trial indicate that one of the two solid forms was absorbed faster
and exhibited higher maximal levels compared to Epidiolex. Both of
the solid formulations were well tolerated.
CBD is a purified product that is not
psychoactive, which we believe has potential benefits for treatment
of inflammatory processes and pain. A major problem in working with
CBD is its low, unpredictable and variable uptake following the
most convenient delivery form, by mouth, as a liquid CBD in oil
like the approved pharmaceutical Epidiolex, given for epilepsy.
To help try to solve this problem, Prof. Domb
and colleagues developed “ProNanoLipospheres” (PNL), a mixture of
components available over-the-counter, which form little droplets
and have been shown to be absorbed from the gastrointestinal tract
into blood. The results of the clinical trial performed on 12
adult males at the Hadassah Hospital, shows that capsules composed
of one of the PNL formulations performed better statistically than
Epidiolex in terms of the speed of absorption and achievement of
maximal levels. The other PNL formulation, also given as a capsule,
was statistically equivalent to Epidiolex in terms of speed of
absorption and achievement of maximal levels.
We believe that a solid formulation for testing
in clinical trials will advance testing CBD in other indications.
CBD has shown promise in studies on treatment of pain,
post-traumatic stress disorder (PTSD), head trauma, and other
indications, yet an oral liquid formulation is undesirable.1 The
new formulations tested by 180 Life Sciences and its collaborators
open a potential path for testing solid CBD given by mouth in a
capsule.
According to Prof. Avi Domb, “If shown via
further clinical testing, 180 Life Sciences’ proprietary solid
formulation for the delivery of CBD may provide medical
professionals with greatly expanded options to prescribe and
deliver CBD in a precisely dosed, high uptake pill format rather
than the current liquid format. This may have potentially
significant commercial market potential by avoiding the complexity
associated with unpredictable liquid formulation delivery. Both
physicians and patients may have broader acceptance of a solid oral
pill format.”
Full study results are not yet available. The
trial results are planned to be submitted for scientific
publication at a later date. We do not anticipate the outcome of
this trial to have any effect on our financial results for the year
ended December 31, 2024.
About 180 Life Sciences Corp.
180 Life Sciences Corp. is a clinical stage biotechnology
company focused on the development of therapeutics for unmet
medical needs in chronic pain, inflammation and fibrosis by
employing innovative research, and, where appropriate, combination
therapy.
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, statements
expressed or implied relating to the properties or potential
benefits of PNL; our ability to commercialize PNL and our other
drug candidates, 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; the Company’s ability to meet Nasdaq’s conditions for
continued listing on Nasdaq, and the timing relating thereto; the
ability of the Company to maintain the continued listing of the
Company’s securities on The Nasdaq Stock Market, including that the
Company is not currently in compliance with Nasdaq’s continued
listing standards; the review and evaluation of strategic
transactions and their impact on shareholder value; the process by
which the Company engages in evaluation of strategic transactions;
the outcome of potential future strategic transactions and the
terms thereof; the ability of the Company to raise funding, the
terms of such funding, and dilution caused thereby; risks regarding
the outcome of pharmaceutical studies, the timing and costs
thereof, and the ability to obtain sufficient participants; the
timing of, outcome of, and results of, clinical trials statements
regarding the timing of marketing authorization application (MAA)
submissions to the UK Medicines and Healthcare products Regulatory
Agency (MHRA) and New Drug Application submissions (NDA) to the
U.S. Food and Drug Administration (FDA), our ability to obtain
approval and acceptance thereof, the willingness of MHRA to review
such MAA and the FDA to review such NDA, and our ability to address
outstanding comments and questions from the MHRA and FDA;
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, the costs thereof, closures of such trials prior
to enrolling sufficient participants in connection therewith,
issues raised by the 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 and
costs 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; 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; 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 trials
and 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; competition, including technological advances,
new products and patents attained by competitors; challenges to
patents; changes to applicable laws and regulations, including
global health care reforms; expectations with respect to future
performance, growth and anticipated acquisitions; expectations
regarding the capitalization, resources and ownership structure of
the Company; 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 the Company’s 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 or lawsuits alleging that we
have violated the intellectual property of others; 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; and the effect of changing
interest rates and inflation, economic downturns and recessions,
declines in economic activity or global conflicts. 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, 2023, and Quarterly Report on Form 10-Q for
the quarter ended March 31, 2024, 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:
Please contact Blair Jordan, Interim CEO –
bjordan@180lifesciences.com
1 See, for example:
- Izzo, A. A., Borrelli, F., Capasso, R., Di Marzo, V. &
Mechoulam, R. Non-psychotropic plant cannabinoids: new therapeutic
opportunities from an ancient herb. Trends Pharmacol. Sci.
30, 515–527 (2009).
- Hayakawa, K. et al. Therapeutic time window of cannabidiol
treatment on delayed ischemic damage via high-mobility group
box1-inhibiting mechanism. Biol. Pharm. Bull. 32,
1538–44 (2009).
- Chagas, M. H. N. et al. Cannabidiol can improve complex
sleep-related behaviours associated with rapid eye movement sleep
behaviour disorder in Parkinson’s disease patients: a case series.
J. Clin. Pharm. Ther. 39, 564–566 (2014).
- Giacoppo, S. et al. A new formulation of cannabidiol in cream
shows therapeutic effects in a mouse model of experimental
autoimmune encephalomyelitis. DARU J. Pharm. Sci.
23, 48 (2015).
- Pertwee, R. G. Cannabinoids and multiple sclerosis. Mol.
Neurobiol. 36, 45–59 (2007).
- Parker, L. A., Mechoulam, R. & Schlievert, C. Cannabidiol,
a non-psychoactive component of cannabis and its synthetic
dimethylheptyl homolog suppress nausea in an experimental model
with rats. Neuroreport 13, 567–570 (2002).
- Ribeiro, A. et al. Cannabidiol, a non-psychotropic
plant-derived cannabinoid, decreases inflammation in a murine model
of acute lung injury: Role for the adenosine A2A receptor. Eur. J.
Pharmacol. 678, 78–85 (2012).
- WHO, W. H. O. Cannabidiol (CBD): pre-review report. Expert
Committee on Drug Dependence 39, (2017).
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