180 Life Sciences Corp. (NASDAQ: ATNF) (“180 Life Sciences” or the
“Company”), a clinical-stage biotechnology company announced that
the first patient has been randomized in the clinical trial to
evaluate anti-tumor necrosis factor (TNF) for patients with
early-stage, pain predominant frozen shoulder.
“Recruiting the first patient for the trial of anti-TNF therapy
in frozen shoulder patients is a significant milestone,” said James
Woody, M.D., Chief Executive Officer of 180 Life Sciences.
“Treatment with anti-TNF at the early stage could improve pain and
subsequently reduce disability for frozen shoulder patients.”
180 Life Sciences is supporting the study funded by the National
Institute of Health and Care Research (NIHR) in the U.K. to
investigate whether injections of anti-TNF during the early stages
of frozen shoulder can reduce or prevent progression of the
disease. The trial is sponsored by the University of Oxford and is
led by Professor Nanchahal, consultant for 180 Life Sciences,
together with his colleague Professor Sally Hopewell based at the
Oxford Clinical Trials Research Unit, at the University of Oxford.
180 Life Sciences also has the rights for advancing these studies
and commercialization of the trial results.
Approximately 50% of patients with Dupuytren’s disease also have
frozen shoulder and Professor Nanchahal has previously shown that
that TNF, a pro-inflammatory protein, is a key driver of the
fibrosis in early-stage Dupuytren’s disease.(1, 2) He led the
successful phase 2a(3) and phase 2b(4) clinical trials of anti-TNF
for Dupuytren’s disease. This frozen shoulder trial is a
multicenter, randomized, double blind placebo controlled clinical
trial to assess the feasibility of conducting a phase 3 clinical
trial.(5).
Prof Sir Marc Feldmann, FRS, Executive Co-chairman of the
Company, who is widely recognized for his pioneering work leading
up to the first successful use of anti-TNF for treating intractable
rheumatoid arthritis, said “it is a pleasure to see 180 Life
Sciences focusing on developing new uses for anti-TNF which has
been one of the most successful drug classes of all time, and
conducting clinical trials to fulfil unmet needs that anti-TNF can
ameliorate.”
About Frozen Shoulder
Frozen shoulder, or adhesive capsulitis, is very common,
affecting about 9% of adults.(6) The early stages are extremely
painful and later stages are characterized by stiffness and
limitation of motion, which gradually improves.(7) Current
treatments include physical therapy and steroid injections, which
have modest short-term benefits with no evidence of long-term
benefit.(8, 9) Around 40% of patients have persistent stiffness 4
years after onset and may require surgery.(10)
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 primary platform is a novel program to treat several
inflammatory disorders using anti-TNF (tumor necrosis factor).
About The National Institute for Health
and Care Research (NIHR)
The mission of the National Institute for Health and Care
Research (NIHR) is to improve the health and wealth of the nation
through research. We do this by:
- Funding high quality, timely research that benefits the NHS,
public health and social care;
- Investing in world-class expertise, facilities and a skilled
delivery workforce to translate discoveries into improved
treatments and services;
- Partnering with patients, service users, carers and
communities, improving the relevance, quality and impact of our
research;
- Attracting, training and supporting the best researchers to
tackle complex health and social care challenges;
- Collaborating with other public funders, charities and industry
to help shape a cohesive and globally competitive research
system;
- Funding applied global health research and training to meet the
needs of the poorest people in low and middle income
countries.
NIHR is funded by the Department of Health and Social Care. Its
work in low and middle income countries is principally funded
through UK Aid from the UK government.
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 FDA and MHRA, timing to
complete required studies and trials, and timing to obtain
governmental approvals; the potential that earlier clinical trials
and studies may not be predictive of future results; 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; 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
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 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. 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 June 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
Suzanne MessereStern Investor Relations, Inc.(212)
698-8801Suzanne.Messere@sternir.com
- L. S. Verjee et al., Unraveling the signaling pathways
promoting fibrosis in Dupuytren's disease reveals TNF as a
therapeutic target. Proceedings of the National Academy of Sciences
of the United States of America 110, E928-937
(2013).
- D. Izadi et al., Identification of TNFR2 and IL-33 as
therapeutic targets in localized fibrosis. Science Advances
5, eaay0370 (2019).
- J. Nanchahal et al., Anti-Tumour Necrosis Factor Therapy for
Dupuytren's Disease: A Randomised Dose Response Proof of Concept
Phase 2a Clinical Trial. EBioMedicine 33, 282-288
(2018).
- 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 Rheumatology
4 e407 - e416 (2022).
- S. Hopewell et al., Anti-TNF (adalimumab) injection for the
treatment of adults with frozen shoulder during the pain
predominant stage protocol for a multi-centre, randomised, double
blind, parallel group, feasibility trial. NIHR Open Research
2, 28 (2022).
- K. Walker-Bone, K. T. Palmer, I. Reading, D. Coggon, C. Cooper,
Prevalence and impact of musculoskeletal disorders of the upper
limb in the general population. Arthritis and Rheumatism
51, 642-651 (2004).
- A. Rangan, N. Hanchard, C. McDaid, What is the most effective
treatment for frozen shoulder? British Medical Journal
354, i4162 (2016).
- R. Buchbinder, S. Green, J. M. Youd, Corticosteroid injections
for shoulder pain. Cochrane Database Syst Rev, CD004016
(2003).
- M. J. Page et al., Manual therapy and exercise for adhesive
capsulitis (frozen shoulder). Cochrane Database Syst Rev, CD011275
(2014).
- A. Rangan et al., Management of adults with primary frozen
shoulder in secondary care (UK FROST): a multicentre, pragmatic,
three-arm, superiority randomised clinical trial. Lancet
396, 977-989 (2020).
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