Endo Presents Data at the American Orthopaedic Foot & Ankle Society Annual Meeting
Endo (OTCQX: NDOI) presented data from a Phase 2 clinical study of collagenase clostridium histolyticum (CCH) in patients with plantar fibromatosis at the American Orthopaedic Foot & Ankle Society's annual meeting. The study showed a trend in CCH treatment effect over placebo for reducing pain, as measured by the Foot Function Index Total Pain subscale score. There were also nominally significant improvements in investigator assessment, nodular hardness, and nodule consistency. The safety profile of CCH was consistent with previous studies, with most adverse events being local and mild to moderate. No treatment-related serious adverse events were reported. Endo is currently enrolling patients for a pivotal Phase 3 program for CCH in plantar fibromatosis.
Endo (OTCQX: NDOI) ha presentato dati da uno studio clinico di Fase 2 su collagenasi clostridium histolyticum (CCH) in pazienti con fibromatosi plantare durante l'incontro annuale della American Orthopaedic Foot & Ankle Society. Lo studio ha mostrato una tendenza nell'effetto del trattamento con CCH rispetto al placebo per la riduzione del dolore, misurata attraverso il punteggio del subscalare totale del Foot Function Index. Sono stati anche osservati miglioramenti nominalmente significativi nella valutazione da parte degli investigatori, nella durezza nodulare e nella consistenza del nodulo. Il profilo di sicurezza di CCH è stato coerente con studi precedenti, con la maggior parte degli eventi avversi locali e di entità da lieve a moderata. Non sono stati riportati eventi avversi gravi correlati al trattamento. Endo sta attualmente reclutando pazienti per un programma pivotale di Fase 3 per CCH nella fibromatosi plantare.
Endo (OTCQX: NDOI) presentó datos de un estudio clínico de Fase 2 sobre collagenasa clostridium histolyticum (CCH) en pacientes con fibromatosis plantar en la reunión anual de la American Orthopaedic Foot & Ankle Society. El estudio mostró una tendencia en el efecto del tratamiento con CCH sobre el placebo para reducir el dolor, medido a través de la puntuación del subescala del dolor total del Foot Function Index. También hubo mejoras significativamente nominales en la evaluación del investigador, la rigidez nodular y la consistencia del nódulo. El perfil de seguridad de CCH fue consistente con estudios anteriores, siendo la mayoría de los eventos adversos locales y de leve a moderado. No se informaron eventos adversos graves relacionados con el tratamiento. Endo está actualmente reclutando pacientes para un programa pivotal de Fase 3 para CCH en la fibromatosis plantar.
Endo (OTCQX: NDOI)는 미국 정형외과 발 및 발목 학회의 연례 회의에서 식물 섬유종증 환자에서 콜라제나제 클로스트리듐 히스토리티쿰 (CCH)에 대한 2상 임상 연구 데이터를 발표했습니다. 연구 결과 플라시보 대비 CCH 치료 효과의 경향이 나타났으며, 이는 Foot Function Index의 총 통증 하위 척도를 통해 측정되었습니다. 또한 조사자의 평가, 결절 경도 및 결절 일관성에서 명목상으로 유의미한 개선이 있었습니다. CCH의 안전성 프로파일은 이전 연구들과 일관되었으며, 대부분의 부작용은 국소적이며 경미하거나 중등도였습니다. 치료와 관련된 중대한 부작용은 보고되지 않았습니다. Endo는 현재 식물 섬유종증에 대한 CCH의 중요한 3상 프로그램을 위해 환자를 모집하고 있습니다.
Endo (OTCQX: NDOI) a présenté des données d'une étude clinique de Phase 2 sur collagénase clostridium histolyticum (CCH) chez des patients atteints de fibromatose plantaire lors de la réunion annuelle de l'American Orthopaedic Foot & Ankle Society. L'étude a montré une tendance à l'effet du traitement par CCH par rapport au placebo pour réduire la douleur, mesurée par le score de la sous-échelle douleur totale de l'index de fonction du pied. Il y a également eu des améliorations nominalement significatives dans l'évaluation par l'investigateur, la dureté nodulaire et la consistance du nodule. Le profil de sécurité de CCH était cohérent avec les études précédentes, la plupart des événements indésirables étant locaux et légers à modérés. Aucun événement indésirable grave lié au traitement n'a été signalé. Endo recrute actuellement des patients pour un programme pivot de Phase 3 pour CCH dans la fibromatose plantaire.
Endo (OTCQX: NDOI) präsentierte Daten aus einer Phase-2-Studie zu Collagenase Clostridium histolyticum (CCH) bei Patienten mit Plantarfasziitis auf dem Jahrestreffen der American Orthopaedic Foot & Ankle Society. Die Studie zeigte einen Trend zur Wirkung der CCH-Behandlung im Vergleich zu Placebo zur Schmerzlinderung, gemessen anhand des Scores des Gesamt-Schmerzmesssystems des Foot Function Index. Es gab auch nominal signifikante Verbesserungen bei der Bewertung der Prüfer, der Knoten-Härte und der Noden-Konsistenz. Das Sicherheitsprofil von CCH war konsistent mit früheren Studien, wobei die meisten unerwünschten Ereignisse lokal und mild bis moderat waren. Es wurden keine behandlungsbedingten schwerwiegenden unerwünschten Ereignisse gemeldet. Endo rekrutiert derzeit Patienten für ein wichtige Phase-3-Programm zu CCH bei Plantarfibromatose.
- Trend in CCH treatment effect over placebo for reducing pain in plantar fibromatosis
- Nominally significant improvements in investigator assessment, nodular hardness, and nodule consistency
- Consistent safety profile with previous CCH studies
- Ongoing enrollment for pivotal Phase 3 program
- CCH is not yet approved for treating plantar fibromatosis
"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
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SOURCE Endo, Inc.
FAQ
What were the results of Endo's Phase 2 study for CCH in plantar fibromatosis?
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