A correction has been issued for the release disseminated
under the same headline on Thursday, November 15th by 180 Life
Sciences Corp. An embedded link has been added to the 5th
paragraph. The complete and corrected release follows.
180 Life Sciences Corp. (NASDAQ: ATNF) (“180 Life Sciences” or
the “Company”), a clinical-stage biotechnology company today
announced that researchers at Oxford Population Health’s Health
Economics Research Centre and the Kennedy Institute of Rheumatology
have found that anti-TNF treatment (adalimumab), which is commonly
used to treat conditions such as rheumatoid arthritis and
psoriasis, is likely to be a cost-effective treatment for people
affected by early-stage Dupuytren’s disease.
Dupuytren’s disease affects more than 5 million people in the
UK. It causes the fingers to irreversibly curl into the palm due to
nodules of tissue forming cords under the skin, impairing hand
function and quality of life. There is currently no approved
treatment for early-stage disease. All treatments available for
late-stage disease have limitations, including the potential for
recurrence.
A recent phase 2b trial (an early stage trial designed to test
whether a treatment provides a beneficial effect) led by Professor
Jagdeep Nanchahal of the Kennedy Institute of Rheumatology,
University of Oxford, who is also a consultant to the Company,
found that a course of four adalimumab injections significantly
reduced hardness and size of early-stage Dupuytren’s disease
nodules.
Based on the results of the Repurposing Anti-TNF for Treating
Dupuytren's Disease (RIDD) trial, the study’s researchers analysed
data on costs and quality of life. They extrapolated the trial
results using a patient-level simulation model, which estimated the
lifetime cost-effectiveness of adalimumab for treatment of
Dupuytren’s Disease. The simulated model also evaluated
hypothetical repeated courses of adalimumab each time the nodule
reactivated (every three years) in patients who initially responded
to treatment.
The researchers’ simulation found that repeated courses of
intranodular injections of adalimumab are likely to be
cost-effective for treating progressive early-stage Dupuytren’s
disease. The model-based extrapolation showed that, over a
lifetime, repeated courses of adalimumab are likely to cost £14,593
per quality-adjusted life-year (QALY)* gained, compared with
current UK National Health Service (NHS) practice. This would be
considered highly cost-effective compared with the £20,000 per
QALY* gained that the NHS is typically willing to pay.
Lead author, Dr Helen Dakin, University Research Lecturer at
Oxford Population Health’s Health Economics Research Centre, said:
“Adalimumab is likely to be a cost-effective treatment for
progressive early-stage Dupuytren’s disease.”
The study’s authors estimated that around 2.6 million people in
the UK may have progressive early-stage Dupuytren’s disease. “Our
phase 2b data shows that Adalimumab has the potential to transform
the management of progressive early-stage Dupuytren’s disease. It
is important that the treatment is cost-effective if it is to
become available to patients,” said Professor Nanchahal.
“Determining that Adalimumab is likely to be cost effective for
early-stage Dupuytren’s disease is an important step towards
working to successfully bring the treatment to market and making it
widely available to patients. This, combined with our extensive
patent estate, has provided strong interest in ongoing preliminary
partnership discussions for the commercialization of this novel
therapeutic approach,” said Dr. James Woody, CEO of 180 Life
Sciences.
The research was funded by the Health Innovation Challenge Fund
(Wellcome, Department of Health and Social Care) and 180 Life
Sciences. Dr. Dakin is part-funded by the National Institute for
Health and Care Research Oxford Biomedical Research Centre. The
study is published in Bone and Joint Open.
* Quality Adjusted Life Years (QALYs) are a standard metric used
to compare the cost-effectiveness of different healthcare
interventions. One QALY is equivalent to an additional year gained
at full health.
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
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 timing and outcome of the Company’s
planned meeting with MHRA, including the Company’s ability to
persuade MHRA that such 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 behaviour 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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