- Two presentations include data from a Phase 2 study of collagenase clostridium histolyticum (CCH) in patients with plantar fibromatosis
- Endo is currently enrolling patients in a Phase 3 study
- A third presentation reports on a retrospective data analysis of transcription notes describing the clinical characteristics of patients with plantar fibromatosis
MALVERN, Pa., Aug. 8, 2024 /PRNewswire/ -- Endo, Inc. ("Endo") (OTCQX: NDOI) announced today that new data related to collagenase clostridium histolyticum (CCH) and plantar fibromatosis will be presented during the American Podiatric Medical Association's (APMA) annual scientific meeting, The National, taking place August 8-11, 2024 in Washington, DC.
Two presentations cover data from the Phase 2 clinical study of CCH in patients with plantar fibromatosis, and a third presentation shares a retrospective analysis of plantar fibromatosis patients' medical records.
"We're pleased to share new data about plantar fibromatosis with healthcare providers who care for and treat patients with the condition, which can be painful and burdensome," said James P. Tursi, M.D., Executive Vice President, Global Research & Development at Endo. "Encouraged by the clinical study data being presented at APMA, we are advancing our Phase 3 clinical study to explore a potential nonsurgical option in the future."
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.
The retrospective analysis of 2,273 patient charts demonstrated that patients with plantar fibromatosis appear to suffer from both direct and indirect symptom burdens. Almost two-thirds of patients in the overall cohort reported PFI-specific foot pain with nearly 90% of these describing the pain as moderate or severe. The analysis also reported on current treatment approaches for plantar fibromatosis.
The three new 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
- 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
- Clinical Characteristics of Plantar Fibromatosis Derived from Transcription Notes
- Authors: Jill Davis, David Hurley, Jennifer Black-Shinn, Fernando Otalora, Esteban Masuelli, Eddie Davis
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, 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 recently filed final prospectus 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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