- Presentations include data from Phase 1 and Phase 2 studies
of collagenase clostridium histolyticum (CCH) in patients with
plantar fibromatosis
- Endo is currently enrolling patients in a Phase 3
study
MALVERN,
Pa., Oct. 18, 2024 /CNW/ -- Endo, Inc. ("Endo")
(OTCQX: NDOI) announced today that data related to the use of
collagenase clostridium histolyticum (CCH) for the treatment of
plantar fibromatosis will be presented during the American Society
of Podiatric Surgeons (ASPS) Surgical Conference, taking place
October 18-19, 2024.
Two presentations cover data from the Phase 2 clinical study of
CCH in patients with plantar fibromatosis, and the third
presentation includes data from a Phase 1 study.
"We're pleased to share data with healthcare providers about our
plantar fibromatosis clinical trials to help improve patient care
and discuss our clinical development program," said James P. Tursi, M.D., Executive Vice President,
Global Research & Development at Endo. "These presentations
also demonstrate our growth strategy to develop a musculoskeletal
pipeline serving those suffering from this and other burdensome
conditions."
The three e-poster presentations are below:
- A Phase 2, Double-blind, Randomized, Placebo-Controlled Study
to Assess Collagenase Clostridium Histolyticum vs Placebo in
Patients With Plantar Fibromatosis
- Authors: Joseph Caporusso, DPM; Ira Gottlieb, DPM; Jason
Levy, DPM, FACFAS; Saadiq
El-Amin, MD; Sara E. Suttle,
DPM, FACFAS; James Tursi, MD;
Nigel Jones, PharmD; Luis Ortega, MD; Gongfu Zhou, PhD; C.
James Anderson, DPM
- Presenter: Luis Ortega, MD
- Characterization of Patients With Plantar Fibromatosis:
Examining Baseline Characteristics From a Phase 2 Study of
Collagenase Clostridium Histolyticum
- Authors: Joseph Caporusso, DPM; Ira Gottlieb, DPM; Jason
Levy, DPM, FACFAS; Saadiq
El-Amin, MD; Sara E. Suttle,
DPM, FACFAS; James Tursi, MD;
Nigel Jones, PharmD; Luis Ortega, MD; Gongfu Zhou, PhD; C.
James Anderson, DPM
- Presenter: Luis Ortega, MD
- The Safety and Tolerability of Collagenase Clostridium
Histolyticum (CCH) in Plantar Fibromatosis (PFI): A Phase 1,
Dose-Ranging Study
- 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
- Presenter: David Hernandez, MD
CCH is not approved for use in treating patients with plantar
fibromatosis. Endo is currently enrolling patients in the pivotal
Phase 3 program.
About Phase 1 Clinical Study
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.
About Phase 2 Clinical Study
The results of the Phase
2 plantar fibromatosis study demonstrated a trend in CCH treatment
effect over placebo for reducing pain associated with the condition
as measured by the Foot Function Index Total Pain subscale score,
as well as nominally significant improvements of CCH versus placebo
in the investigator assessment of improvement, nodular hardness
(durometer), and nodule consistency (firmness by investigator
palpation) scales. In addition, the CCH safety profile was
consistent with the known CCH safety profile from other clinical
studies and indications. Most adverse events were rated as mild to
moderate, and there were no reported treatment-related serious
adverse events.
About Plantar Fibromatosis
Plantar fibromatosis (PFI)
or Ledderhose disease 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 is a diversified specialty
pharmaceutical company boldly transforming insights into
life-enhancing therapies. Our passionate team members collaborate
to develop and deliver these essential medicines. Together, we are
committed to helping everyone we serve live their best life. Learn
more at www.endo.com or connect with us on LinkedIn.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking
statements including, but not limited to, the statements by Dr.
Tursi and any statements relating to product efficacy, clinical
trials or studies, patient enrollment, presentation of data,
potential treatments or indications, therapeutic outcomes or
treatment responses, safety or adverse events, clinical
development, growth strategies, and any statements that refer to
expected, estimated or anticipated future results or that do not
relate solely to historical facts. Statements including words such
as "believes," "expects," "anticipates," "intends," "estimates,"
"plan," "will," "may," "look forward," "intends," "guidance,"
"future," "potential" or similar expressions are forward-looking
statements. Because these statements reflect our current views,
expectations and beliefs concerning future events, they involve
risks and uncertainties, some of which we may not currently be able
to predict. Although we believe that these forward-looking
statements and other information are based upon reasonable
assumptions and expectations, readers should not place undue
reliance on these or any other forward-looking statements and
information. Actual results may differ materially and adversely
from current expectations based on a number of factors, including,
among other things, unfavorable safety or efficacy data,
uncertainties in the regulatory approval process, unexpected
litigation or other disputes, our ability to successfully implement
and execute on our strategies and initiatives, and changes in
competitive, market or regulatory conditions. Endo assumes no
obligation to publicly update any forward-looking statements,
whether as a result of new information, future developments or
otherwise, except as may be required under applicable securities
laws. Additional information concerning risk factors, including
those referenced above, can be found in Endo's press releases and
in its public filings with the U.S. Securities and Exchange
Commission, including the discussion under the heading "Risk
Factors" in Endo's most recent Form 10-Q and in Endo's final
prospectus filed pursuant to Rule 424(b) under the Securities Act
of 1933, as amended, in connection with Endo's Form S-1/A.
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SOURCE Endo, Inc.