- 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 /PRNewswire/ -- 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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