Endo Presents New Data at the American Orthopaedic Foot & Ankle Society Annual Meeting
Three presentations cover data from the Phase 1 clinical study of CCH in patients with plantar fibromatosis. Results demonstrated improvement in nodule hardness and in patient and physician satisfaction scores. 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.
A fourth presentation provides real-world treatment patterns derived from a retrospective observational study that compiles a large database of newly diagnosed patients with plantar fibromatosis. These new data address a gap in our knowledge of plantar fibromatosis treatments.
"We're pleased to share information and facilitate a better understanding of plantar fibromatosis in an effort to help improve treatment outcomes," said
CCH is not approved for use in treating patients with plantar fibromatosis. Endo has completed a Phase 2 study and anticipates that the pivotal Phase 3 program will begin later this year.
The four presentations are below:
- NEW: Treatment patterns for plantar fibromatosis in
the United States: a retrospective observational study (e-poster presentation)
Jill Davis, MS; Aimee Near, MPH; David Hurley, MD; Laurence Djatche, PharmD, MS; Jenny Tse, MS; Riddhi P. Doshi, PhD, MBBS, MPH; Elizabeth J. Wang, MS; Luis A. Ortega, MD; David G. Armstrong, MD, PhD, MS
- Participant Satisfaction and Investigator Assessment of Collagenase Clostridium Histolyticum Injection as a Nonsurgical Intralesional Treatment Option for Plantar Fibromatosis (podium presentation)
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
- Safety Data from a Study of Collagenase Clostridium Histolyticum Injection in Participants With Plantar Fibromatosis (poster presentation)
Richard A. Pollak, DPM; David Hernandez, MD; Christopher J. Anderson, DPM; Shannon R. Dalton, PhD; Qinfang Xiang, PhD; Saji Vijayan, MBBS; Luis Ortega, MD; Joseph M. Caporusso, DPM
- Collagenase Clostridium Histolyticum Injection in Patients With Plantar Fibromatosis: A Randomized, Open-Label, Dose-Ranging Study (e-podium presentation)
Christopher J. Anderson, DPM; Luis Ortega, MD; Joseph M. Caporusso, DPM; Richard A. Pollak, DPM; David Hernandez, MD; Shannon R. Dalton, PhD; Qinfang Xiang, PhD; Saji Vijayan, MBBS
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.
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.
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