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, in collaboration with the University
of Oxford, today announced final results from its Phase 2b study in
patients with Dupuytren’s disease. The positive data results were
published today in The Lancet Rheumatology.
“These 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, “Treatment
with anti-TNF injections could bring long lasting respite and
prevent the disease from advancing to the stage that surgery is
needed to maintain hand function. This study demonstrates that
anti-TNF injections into the hand could have a durable response
following treatment, potentially delaying or preventing the
eventual progression to finger contractions and disability.”
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. Roughly 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 trial was designed as a randomized,
double-blind, placebo-controlled study to assess the efficacy of
local injection of anti-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 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.
The primary endpoint from the Phase 2b trial was
nodule hardness at 12 months measured with a durometer. Nodule
size, a key secondary endpoint, was measured using an ultrasound
scan at 12 and 18 months. Key findings of the study were:
- Nodule hardness was lower in the
anti-TNF treatment arm compared to placebo (-4.6AU; 95% CI -7.1 to
-2.2; p=<0.0002) at 12 months and decreased further at 18 months
(-5.8AU; 95% CI -8.7 to -3.0; p=<0.0001), 9 months after the
last injection.
- Nodule size (area), measured using
ultrasound scan, was also lower in the anti-TNF treatment arm
compared to placebo at 12 months (-8.4mm2; 95% CI -13.8 to -2.9;
p=<0.0025), and decreased further at 18 months (-14.4mm2; 95% CI
-19.9 to -9.0; p=<0.0001).
- There were no treatment-related
serious adverse events in the trial.
- Patient compliance was high, with
84% returning for all 4 injections.
- Fewer patients in the treatment
group underwent or were awaiting surgery compared to placebo at 18
months. However, the overall numbers were small and longer-term
follow up would be required to confirm this.
“We believe that these results herald a dramatic change in
treatment options for Dupuytren’s disease,” said Professor Sir Marc
Feldmann, Founder and Co-Chairman of 180 Life Sciences. “These
results show that Anti-TNF injections into the hand can be
effective in controlling the palmar nodule, potentially preventing
or reducing disease progression and avoiding the need for much more
invasive treatments.”
In conclusion, the data showed that in patients
receiving anti-TNF treatment, nodules continued to soften and
regress at the 18-month follow up, which was nine months after the
final dose. These results suggest that treatment of early-stage
Dupuytren’s disease with adalimumab can have a profound local
biological effect and potentially provide a much-needed early
therapeutic option for patients with a chronic, debilitating
disease.
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. Issue: pages (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. These reports and
filings are available at www.sec.gov. 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
Media Relations:David SchullRusso
Partners (212)
845-4271 David.Schull@russopartnersllc.com
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