DUBLIN, March 13, 2023 /PRNewswire/ -- Endo International
plc (OTC: ENDPQ) today announced top-line results from its
Phase 2 clinical study of collagenase clostridium histolyticum
(CCH) in participants with plantar fibromatosis. While the primary
endpoint when analyzed with the overall study population did not
meet statistical significance, a large patient sub-population
showed statistically significant improvement. The primary endpoint
was improvement from baseline in the Foot Function Index (FFI) Pain
Scale score when compared to those receiving placebo.
The overall clinical study population met some key secondary and
exploratory endpoints, including the investigator assessment of
improvement (Clinician Global Impression of Change), nodule
hardness and improvement in nodule consistency. The large patient
sub-population met the primary endpoint, as well as the majority of
all secondary and exploratory endpoints.
The CCH safety profile in the Phase 2 clinical study was
consistent with the known CCH safety profile from other studies.
Most adverse events were rated as mild to moderate and there were
no treatment-related serious adverse events.
"We believe we have a clear path forward to Phase 3 development
for CCH in patients with plantar fibromatosis," said James P. Tursi, M.D., Executive Vice President,
Global Research & Development at Endo. "The Phase 2 clinical
study data will help us refine our Phase 3 clinical study design,
and we plan to begin the pivotal program later this year. We remain
committed to developing and providing nonsurgical treatments to
help everyone we serve live their best lives."
"This clinical study was designed to test multiple variables
with a goal to identify an optimal path to Phase 3 development, and
we were successful in doing that," said Dr. Joseph M. Caporusso, a Texas-based podiatrist and a lead
clinical investigator for the Phase 2 study. "We look forward to
further investigation of CCH in patients with plantar fibromatosis
with the ultimate goal of providing patients the first non-surgical
treatment for this condition."
About Phase II Clinical Trial
The double-blind,
placebo-controlled Phase 2 clinical trial enrolled 176 total
participants with single or multiple nodules. Participants were
randomized 1:1 to receive CCH or placebo. Participants received up
to two treatments, depending on nodule size, separated by a minimum
of 28 days. At pre-specified timepoints, participants completed the
Foot Function Index (FFI), a patient-completed questionnaire that
measures the impact of certain foot disorders in terms of pain,
disability and activity restriction.
The primary endpoint was the change from baseline in the FFI
Pain Scale score at the day 57 visit. Additional endpoints included
changes in the FFI Disability Scale score, FFI Activity Restriction
Scale score and numerical pain score, as well as changes in nodule
hardness and consistency.
About Plantar Fibromatosis
Plantar fibromatosis (PFI),
sometimes termed "Dupuytren's disease of the foot," is a
hyperproliferative fibrous tissue disorder resulting in the
formation of nodules along the plantar fascia, the thick connective
tissue that supports the arch of the foot, which is often painful.
There is no cure for PFI. Symptom management options include custom
insoles, topical treatments, over-the-counter pain and
anti-inflammatory medications, radiation therapy and steroid
injections, and ultimately, surgery may be required to remove the
nodules.
About Endo
Endo (OTC: ENDPQ) is a specialty
pharmaceutical company committed to helping everyone we serve live
their best life through the delivery of quality, life-enhancing
therapies. Our decades of proven success come from passionate team
members around the globe collaborating to bring treatments forward.
Together, we boldly transform insights into treatments benefiting
those who need them, when they need them. Learn more
at www.endo.com or connect with us on LinkedIn.
Forward-Looking Statements
Certain information in this
press release may be considered "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995
and any applicable Canadian securities legislation including, but
not limited to, the statements by Drs. Tursi and Caporusso and any
statements relating to clinical trials or studies, potential
treatments or indications, future research, safety, adverse events,
development plans, timelines or expectations, and any statements
that refer to expected, estimated or anticipated future results or
that do not relate solely to historical facts. Statements including
words or phrases such as "believe," "expect," "anticipate,"
"intend," "estimate," "plan," "will," "may," "look forward,"
"intend," "guidance," "future," "potential" or similar expressions
are forward-looking statements. All forward-looking statements in
this communication reflect the Company's current views as of the
date of this communication about its plans, intentions,
expectations, strategies and prospects, which are based on the
information currently available to it and on assumptions it has
made. Actual results may differ materially and adversely from
current expectations based on a number of factors, including, among
other things, the outcome of the Company's contingency planning and
restructuring activities; the timing, impact or results of any
pending or future litigation, investigations, proceedings or
claims, including opioid, tax and antitrust related matters; any
actual or contingent liabilities; settlement discussions or
negotiations; the Company's liquidity, financial performance, cash
position and operations; the risks and uncertainties associated
with chapter 11 proceedings; the time, terms and ability to confirm
a sale of the Company's businesses under Section 363 of the U.S.
Bankruptcy Code; the risk that the Company's chapter 11 cases may
be converted to cases under chapter 7 of the Bankruptcy Code; the
adequacy of the capital resources of the Company's businesses and
the difficulty in forecasting the liquidity requirements of the
operations of the Company's businesses; the unpredictability of the
Company's financial results; the Company's ability to discharge
claims in chapter 11 proceedings; negotiations with the holders of
the Company's indebtedness and its trade creditors and other
significant creditors; the risks and uncertainties with performing
under the terms of the restructuring support agreement and any
other arrangement with lenders or creditors while in chapter 11
proceedings; the performance, including the approval, introduction,
and consumer and physician acceptance of new products and the
continuing acceptance of currently marketed products; and the
Company's ability to obtain and successfully manufacture, maintain
and distribute a sufficient supply of products to meet market
demand in a timely manner. The Company expressly disclaims any
intent or obligation to update these forward-looking statements,
except as required to do so by law.
Additional information concerning risk factors, including those
referenced above, can be found in press releases issued by the
Company, as well as the Company's public periodic filings with the
U.S. Securities and Exchange Commission and with securities
regulators in Canada, including
the discussion under the heading "Risk Factors" in the Company's
most recent Annual Report on Form 10-K and any subsequent Quarterly
Reports on Form 10-Q or other filings with the U.S. Securities and
Exchange Commission. Copies of the Company's press releases and
additional information about the Company are available at
www.endo.com or you can contact the Company's Investor Relations
Department at relations.investor@endo.com.
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