180 Life Sciences Corp. (NASDAQ: ATNF) (“180 Life Sciences” or the
“Company”), a clinical-stage biotechnology company focused on the
development of novel drugs that fulfill unmet needs in inflammatory
diseases, fibrosis and pain announces that it has submitted a
request to the United Kingdom’s Medicines and Healthcare products
Regulatory Agency (MHRA) for a follow up scientific advice meeting
where the Company will seek guidance on a plan to obtain
Conditional Marketing Authorization (CMA) for the use of adalimumab
in the treatment of early stage Dupuytren’s disease.
A meeting with the MHRA is anticipated to take
place in late Q3 of 2023 with the written responses anticipated to
be received prior to year end. The Company’s regulatory consultants
have indicated that initiation of an additional clinical trial
(Phase 3) may be required to obtain CMA approval, and such a trial
has been designed. The regulatory consultants of the Company
believe that it may be possible to obtain a CMA due to the long
safety history of anti-tumor necrosis factor (TNF) therapies,
conditional on a successful Phase 3 trial, which CMA may be granted
prior to the completion of the Phase 3 trial, once patients have
been enrolled, verifying the commitment of the Company to complete
the trial. A CMA would allow the Company to market its therapy for
Dupuytren’s disease in the UK, between the granting of the CMA and
completion of a successful Phase 3 trial. The Phase 3 trial might
utilize sites from various countries, including the United States
(US). Therefore, the Company has submitted a request to the US Food
and Drug Administration (FDA) for a Type C meeting to seek advice
as to requirements for obtaining US marketing approval including
the potential design requirements of the planned Phase 3 clinical
trial. Guidance from the FDA is expected to shape the Company’s
clinical development strategy in the US and possibly in other
countries. In support of our FDA Type C meeting request, a leading
pharmaceutical biosimilar manufacturer will be participating with
180 Life Sciences in the FDA advice discussion. It is anticipated
that the advice discussion will take place in late Q3 or early Q4
of 2023.
Promising data from a Phase 2b Dupuytren’s
treatment trial was published in the June 2022 issue of The Lancet
Rheumatology(1). A follow up publication showed that the therapy
likely would be cost effective, and was economically beneficial(2).
“We believe our results present the potential for an earlier
treatment for patients with Dupuytren’s disease,” said James Woody,
M.D., Chief Executive Officer of 180 Life Sciences, who continued,
“We look forward to feedback from the regulatory agencies which we
believe may help us bring this potential treatment to patients to
prevent the disease from advancing to the stage that surgery, which
is not always effective and pain-free, is needed to maintain hand
function.”
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. The Company’s current primary focus is a novel
program to treat several inflammatory disorders using anti-TNF
(tumor necrosis factor).
- J. Nanchahal et al., Anti-tumour
necrosis factor therapy for early-stage Dupuytren's disease (RIDD):
a phase 2b, randomised, double-blind, placebo-controlled trial.
Lancet Rheumatol 4, E407-E416 (2022)
- H. Dakin et al., Cost-effectiveness
of adalimumab for early-stage Dupuytren's disease : an economic
evaluation based on a randomized controlled trial and
individual-patient simulation model. Bone Jt Open
3, 898-906 (2022).
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 a planned pharmacokinetics (PK) study, the
timing and costs thereof, and the ability to obtain sufficient
participants; our ability to commercialize our drugs, 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 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 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 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;
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 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; 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, 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, 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.Jason@180lifesciences.com
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