180 Life Sciences Provides Update on Correspondence Received from U.K. and U.S. Regulatory Authorities on Pathway for a Therapy That Could Prevent Progression of Early-Stage Dupuytren’s Disease
June 14 2022 - 4:15PM
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 receipt of a written
response from the U.K. Medicines and Healthcare products Regulatory
Agency (MHRA) and from the U.S. Food and Drug Administration (FDA)
related to questions submitted in a Type C meeting request on the
Company’s planned use of anti-TNF treatment, adalimumab, to treat
early-stage Dupuytren’s disease
Dupuytren’s disease is a common chronic,
progressive fibrotic condition of the hand that causes the fingers
to curl irreversibly into the palm and can be very disabling.
Approximately 20-35% of patients with a palmar nodule of
early-stage Dupuytren’s disease progress to finger contractures.
Roughly 12 million people in the U.S., 2.5 million in the U.K. and
18 million in the EU have early-stage progressive Dupuytren’s
disease. Currently, there is no approved treatment for these
patients, who 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 MHRA provided initial feedback following a
scientific advice meeting. The agency agreed that there is no need
for further non-clinical studies for the planned use of anti-TNF
treatment, adalimumab, to treat early-stage Dupuytren’s disease and
the absence of non-clinical studies can be supported by review of
the literature. The MHRA indicated that while it is biologically
plausible that the primary endpoint of nodule hardness and
secondary endpoint of nodule size could correlate with disease
progression, they would require evidence to validate them as
clinically meaningful surrogate endpoints. Without evidence that
the endpoints used in the Phase 2b trial are predictive of clinical
endpoints and addressing other identified study issues, it is
unlikely Phase 2b study would be considered acceptable as a single
pivotal study to support a Marketing Authorization Application. The
Company is in the process of preparing the evidence to support the
Phase 2b endpoints and to address other MHRA concerns.
The FDA provided written responses to the
Company’s questions on clinical trial endpoints posed in a request
for a Type C meeting. The FDA indicated that the proposed outcome
measures of nodule hardness and nodule size are not clinical
outcome measures that measure how a patient feels, functions, or
survives, which would be needed to support a demonstration of
efficacy in registrational studies. The FDA recommended considering
a pre-investigational new drug (PIND) meeting request to receive
further regulatory guidance. The Company plans to request a
PIND meeting.
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, 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 March 31, 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
Media Relations:David SchullRusso
Partners (212)
845-4271 David.Schull@russopartnersllc.com
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