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, today announced, following publication
of promising data from a Phase 2b Dupuytren’s trial in the June
2022 issues of The Lancet Rheumatology, that 180 Life Sciences has
initiated preliminary consultations with regulatory agencies in
both the UK and USA, with the assistance of Kinexum, the Company’s
regulatory advisor.
At a scientific advice meeting with the Medicines and Healthcare
products Regulatory Agency (UK MHRA), on May 18, 2022, the Company
presented the results of the Phase 2b trial and received guidance
on the path forward for further development. The Company awaits
formal feedback from UK MHRA.
The U.S. Food and Drug Administration (US FDA) has agreed to
provide a written response to the Company’s briefing materials
including the results of the Phase 2B trial, on a Type C meeting
request. Guidance from the FDA is expected to shape the Company’s
clinical development strategy in the USA.
“We believe our recent results present the
potential for an earlier treatment for patients with Dupuytren’s
disease, which is easy to diagnose at an early stage,” 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 is needed to maintain hand function.”
Fibrosis of the hand, known as Dupuytren’s
disease, is a common chronic, progressive condition that causes the
fingers to curl irreversibly into the palm and can be very
disabling. Approximately 20-35% of patients with a palmar nodule
progress to finger contractures. Based on our analysis of publicly
available data, we estimate that approximately 12 million patients
in the U.S., 2.5 million in the U.K. and 22 million in the EU have
Dupuytren’s disease. Currently, there is no approved treatment for
early-stage disease and patients must wait until the disease
progresses with loss of hand function before undergoing surgery or
treatment with collagenase. Unfortunately, the disease tends to
recur after these treatments.
The Phase 2b trial1 was designed as a
randomized, double-blind, placebo-controlled study to assess the
efficacy of local injection of anti-Tumor Necrosis Factor (TNF)
treatment, adalimumab, in participants with early-stage Dupuytren’s
disease and was led by Professor Jagdeep Nanchahal,
clinician-scientist at the University of Oxford and Chairman of the
Clinical Advisory Board at 180 Life Sciences who said: “This trial
represents the clinical translation of our laboratory findings
where we identified of TNF as a therapeutic target2,3, and the
Phase 2a dose ranging clinical trial to identify the optimal dose
and formulation4 effective in downregulating myofibroblasts”, the
cells that generate the cords that cause the fingers to curl into
the palm. The trial recruited 140 patients from two sites in the
U.K. Patients were randomized 1:1 to the treatment arm or placebo.
Patients in the treatment arm received four injections of 40mg
adalimumab in 0.4ml at baseline, which was determined to be most
efficacious in the earlier Phase 2a study, at three, six and nine
months. Patients were followed up at 12 and 18 months. Eligibility
criteria included adults with early-stage Dupuytren’s disease and a
clinically distinct nodule with a clear history of progression in
the preceding six months. The trial was funded by the Health
Innovation Challenge Fund (Wellcome Trust, Department of Health and
Social Care) and 180 Life Sciences, and sponsored by the University
of Oxford.
References
1. J. Nanchahal, Anti-Tumour Necrosis Factor Therapy for Early
Stage Dupuytren’s Disease (RIDD): a phase 2b randomised double
blind, placebo-controlled trial. The Lancet
Rheumatology. 4, (e407-e416) (2022).2. L. S.
Verjee, Unraveling the signaling pathways promoting fibrosis in
Dupuytren's disease reveals TNF as a therapeutic
target. PNAS. 110
(10), E928-E937 (2013).3. D. Izadi,
Identification of TNFR2 and IL-33 as therapeutic targets in
localized fibrosis. Science
Advances. 5(12), eaay0370 (2019).4. J.
Nanchahal, 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).
About 180 Life Sciences
Corp.
180 Life Sciences Corp. is a clinical-stage
biotechnology company focused on the development of novel drugs
that fulfill unmet needs in inflammatory diseases, fibrosis and
pain by leveraging the combined expertise of luminaries in
therapeutics from Oxford University, the Hebrew University and
Stanford University. 180 Life Sciences is one of the leaders into
solving one of the world’s biggest drivers of disease –
inflammation. The Company is driving groundbreaking studies into
clinical programs, which are seeking to develop novel drugs
addressing separate areas of inflammation for which there are no
effective therapies. The Company’s primary platform is a novel
program to treat fibrosis 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; 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 March 31, 2022. 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
Media Relations:David SchullRusso Partners(212)
845-4271David.Schull@russopartnersllc.com
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