180 Life Sciences Corp. (NASDAQ: ATNF) (“180 Life Sciences” or the
“Company”), today announced that the Company and its regulatory
consultants from the US and the UK, met with the UK Medicines and
Healthcare products Regulatory Agency (MHRA) scientific advice
committee for the second time on October 31, 2022. The Company
provided additional data to MHRA concerning the use of nodule size
and hardness as surrogate markers relating to eventual finger
contraction in Dupuytren’s disease, and raised a series of
questions to MHRA. On November 23, 2022, the Company received
formal written scientific advice regarding such matters.
The MHRA reviewed the primary and secondary
endpoints in the Repurposing Anti-TNF for Treating Dupuytren's
Disease (RIDD) trial and the data provided by the Company. They
noted that it has not been shown that reducing nodule size via
treatment would lead to improvements in terms of disease
progression, which the Company understands, and requested support
for a correlation with clinical outcomes. The MHRA also asked for
additional literature supporting the clinical safety of adalimumab
from other approved indications such as rheumatoid arthritis. The
Company plans to provide further information to the MHRA to address
its comments.
Based on the responses from the MHRA, Alexander
(Zan) Fleming, Founder and Executive Chairman of Kinexum, the
Company’s consultant, and a former FDA reviewer, said “We believe
from the written responses that MHRA would likely review, and could
approve, a marketing approval application (MAA), provided the
Agency’s questions about endpoints and data interpretation are
adequately addressed.”
Dr. James Woody, CEO of 180 Life Sciences,
stated, “Based on the advice of our consultants, the Company is
planning to prepare a MAA with the aim to submit to the MHRA during
2023.” However, there is no assurance that such a submission will
be timely filed, or favorably received or approved.
“We see this as the continuation of our clinical
and regulatory plan to address the huge unmet medical needs of
patients with progressive early-stage Dupuytren’s disease which
affects approximately four percent of the Western population,”
continued Dr. James Woody, CEO of 180 Life Sciences.
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).
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
regarding the timing of our planned MAA, 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 Science’s drug candidates, including potential delays in
the enrollment and completion of clinical trials, issues raised by
the U.S. Food and Drug Administration (FDA) and Medicines and
Healthcare products Regulatory Agency (MHRA); the ability of the
Company to persuade MHRA 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, including the Company’s current non-compliance with such
continued listing requirements due to the trading price of the
Company’s securities; 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, 2021, and Quarterly Report on Form 10-Q for the
quarter ended September 30, 2022, 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(678)
570-6791Jason@180lifesciences.com
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