DUBLIN, July 13, 2023 /PRNewswire/ -- Endo International
plc (OTC: ENDPQ) announced today that new data from a Phase 1 study
of collagenase clostridium histolyticum (CCH) in patients with
plantar fibromatosis will be presented during the American
Podiatric Medical Association's (APMA) annual scientific meeting.
The meeting is taking place now through July
16 in Nashville, Tenn.
Results from the Phase 1 clinical study showed improvement in
nodule hardness and in patient and physician satisfaction scores.
The CCH safety profile in the Phase 1 clinical study was consistent
with the known CCH safety profile from other clinical studies. Most
adverse events were rated as mild to moderate and there were no
treatment-related serious adverse events.
"We're pleased to present new data that explores a potential
nonsurgical option in patients with plantar fibromatosis in the
future," said James P. Tursi, M.D.,
Executive Vice President, Global Research & Development at
Endo.
The three new poster presentations are below:
- Tolerability and Safety of Collagenase Clostridium
Histolyticum Injection in Participants with Plantar
Fibromatosis
-
- Authors: Richard A. Pollak, DPM; Christopher J. Anderson, DPM; David Hernandez, MD; Shannon R. Dalton, PhD; Qinfang Xiang, PhD; Saji
Vijayan, MBBS; Luis Ortega,
MD; Joseph M. Caporusso, DPM
- Efficacy of Collagenase Clostridium Histolyticum
Injection, a Potential Nonsurgical Intralesional Treatment Option
for Plantar Fibromatosis: A Randomized, Open-Label, Dose-Ranging
Study
-
- Authors: Joseph M. Caporusso, DPM; Richard A. Pollak, DPM; David Hernandez, MD; Shannon R. Dalton, PhD; Qinfang Xiang, PhD; Saji
Vijayan, MBBS; Luis Ortega,
MD; Christopher J. Anderson,
DPM
- Participant Satisfaction and Investigator Assessment
of Collagenase Clostridium Histolyticum Injection as a
Nonsurgical Intralesional Treatment Option for Plantar
Fibromatosis
-
- Authors: Christopher J. Anderson, DPM; Richard A. Pollak, DPM; David Hernandez, MD; Shannon R. Dalton, PhD; Qinfang Xiang, PhD; Saji
Vijayan, MBBS; Luis Ortega,
MD; Joseph M. Caporusso, DPM
CCH is not approved for use in treating patients with plantar
fibromatosis. Endo has completed Phase 2 and anticipates that the
pivotal Phase 3 program will begin later this year.
About Plantar Fibromatosis
Plantar fibromatosis (PFI)
or Ledderhose disease, 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.
Cautionary Note Regarding 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 Dr. Tursi , any statements relating to product
efficacy, clinical trials or studies, potential treatments or
indications, therapeutic outcomes or treatment responses, 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.
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