MALVERN, Pa., Sept. 13, 2024 /PRNewswire/ -- Endo, Inc. ("Endo") (OTCQX: NDOI) announced today that data from a clinical study of collagenase clostridium histolyticum (CCH) in patients with plantar fibromatosis were presented during the American Orthopaedic Foot & Ankle Society's (AOFAS) annual scientific meeting, taking place through September 14, 2024.
"Our clinical programs for plantar fibromatosis and plantar fasciitis are key elements of our future musculoskeletal pipeline indications, and we are pleased to share information with the medical community on these important data," said James P. Tursi, MD, Executive Vice President, Global Research & Development at Endo.
The oral presentation covered data from the Phase 2 clinical study of CCH in patients with plantar fibromatosis.
- 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
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 of the condition, nodular hardness measured by durometer, and nodule consistency (firmness) by investigator palpation. In addition, the CCH safety profile was consistent with the known CCH safety profile from other clinical studies and indications. Most adverse events were local, rated as mild to moderate, and there were no reported treatment-related serious adverse events.
CCH is not approved for use in treating patients with plantar fibromatosis. Endo is currently enrolling patients in the pivotal Phase 3 program.
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, 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 observed during clinical studies, preliminary data and trends that may not be predictive of future data or results, clinical study results that may not lead to regulatory approval by the FDA or other regulatory agencies, lower than expected clinical trial site activation or enrollment rates, uncertainties and timing of 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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