Endo Presents New Data at the American Podiatric Medical Association Annual Meeting
Endo (OTCQX: NDOI) presented new data on collagenase clostridium histolyticum (CCH) and plantar fibromatosis at the American Podiatric Medical Association's annual meeting. The presentations included results from a Phase 2 study of CCH in plantar fibromatosis patients and a retrospective analysis of patient medical records.
Key findings from the Phase 2 study showed:
- A trend in CCH treatment effect over placebo for reducing pain
- Nominally significant improvements in investigator assessment, nodular hardness, and nodule consistency
- A safety profile consistent with previous CCH studies
The retrospective analysis of 2,273 patient charts revealed that nearly two-thirds of patients reported foot pain, with 90% describing it as moderate or severe. Endo is currently enrolling patients in a Phase 3 study to further explore CCH as a potential nonsurgical treatment option for plantar fibromatosis.
Endo (OTCQX: NDOI) ha presentato nuovi dati su collagenasi clostridium histolyticum (CCH) e fibromatosi plantare durante il meeting annuale dell'American Podiatric Medical Association. Le presentazioni comprendevano i risultati di uno studio di Fase 2 sui pazienti con fibromatosi plantare e un'analisi retrospettiva delle cartelle cliniche dei pazienti.
I principali risultati dello studio di Fase 2 hanno mostrato:
- Tendenza all'effetto del trattamento con CCH rispetto al placebo per la riduzione del dolore
- Miglioramenti statisticamente significativi nella valutazione dell'investigatore, nella durezza nodulare e nella consistenza del nodo
- Un profilo di sicurezza coerente con studi precedenti su CCH
L'analisi retrospettiva di 2.273 cartelle cliniche ha rivelato che quasi due terzi dei pazienti hanno segnalato dolore ai piedi, con il 90% che lo ha descritto come moderato o severo. Attualmente, Endo sta arruolando pazienti per uno studio di Fase 3 per esplorare ulteriormente CCH come potenziale opzione di trattamento non chirurgico per la fibromatosi plantare.
Endo (OTCQX: NDOI) presentó nuevos datos sobre colagenasa clostridium histolyticum (CCH) y fibromatosis plantar en la reunión anual de la American Podiatric Medical Association. Las presentaciones incluyeron resultados de un estudio de Fase 2 de CCH en pacientes con fibromatosis plantar y un análisis retrospectivo de los registros médicos de los pacientes.
Los hallazgos clave del estudio de Fase 2 mostraron:
- Una tendencia en el efecto del tratamiento con CCH sobre el placebo para reducir el dolor
- Mejoras nominalmente significativas en la evaluación del investigador, dureza nodular y consistencia del nódulo
- Un perfil de seguridad consistente con estudios previos de CCH
El análisis retrospectivo de 2,273 registros de pacientes reveló que casi dos tercios de los pacientes informaron dolor en los pies, y el 90% lo describió como moderado o severo. Actualmente, Endo está inscribiendo pacientes en un estudio de Fase 3 para explorar más a fondo el CCH como una posible opción de tratamiento no quirúrgico para la fibromatosis plantar.
Endo (OTCQX: NDOI)은 미국 족부 의학 협회 연례 회의에서 클로스트리디움 히스토리티쿰 콜라겐제 (CCH) 및 발바닥 섬유종증에 대한 새로운 데이터를 발표했습니다. 발표 내용에는 발바닥 섬유종증 환자를 대상으로 한 2상 연구의 결과와 환자 의료 기록에 대한 소급 분석이 포함되었습니다.
2상 연구의 주요 결과는 다음과 같습니다:
- 통증 감소를 위한 플라시보 대비 CCH 치료 효과의 경향
- 연구자의 평가, 결절 경도 및 결절 일관성에서 명목상 통계적으로 유의미한 개선
- 이전 CCH 연구와 일치하는 안전성 프로필
2,273명 환자의 차트에 대한 소급 분석 결과 3분의 2 가까운 환자가 발 통증을 보고했으며, 90%는 이를 중간 또는 심각하다고 설명했습니다. 현재 Endo는 발바닥 섬유종증에 대한 잠재적인 비수술적 치료 옵션으로서 CCH를 추가로 탐색하기 위한 3상 연구에 참여할 환자를 모집하고 있습니다.
Endo (OTCQX: NDOI) a présenté de nouvelles données sur collagénase clostridium histolyticum (CCH) et fibromatose plantaire lors de la réunion annuelle de l'American Podiatric Medical Association. Les présentations comprenaient des résultats d'une étude de Phase 2 sur des patients atteints de fibromatose plantaire et une analyse rétrospective des dossiers médicaux des patients.
Les résultats clés de l'étude de Phase 2 ont montré :
- Une tendance à l'effet du traitement par CCH par rapport au placebo pour réduire la douleur
- Des améliorations nominalement significatives dans l'évaluation des enquêteurs, la dureté nodulaire et la consistance des nodules
- Un profil de sécurité conforme à celui des études précédentes sur le CCH
L'analyse rétrospective de 2 273 dossiers de patients a révélé que près des deux tiers des patients ont signalé des douleurs aux pieds, 90 % les décrivant comme modérées ou sévères. Actuellement, Endo recrute des patients pour une étude de Phase 3 afin d'explorer davantage le CCH comme option de traitement non chirurgicale potentielle pour la fibromatose plantaire.
Endo (OTCQX: NDOI) stellte neue Daten zu Clostridium histolyticum Collagenase (CCH) und Plantarfibromatose auf der Jahresversammlung der American Podiatric Medical Association vor. Die Präsentationen umfassten Ergebnisse einer Phase-2-Studie bei Patienten mit Plantarfibromatose sowie eine retrospektive Analyse der Patientenakten.
Wesentliche Ergebnisse der Phase-2-Studie zeigten:
- Eine Tendenz zur Wirksamkeit der CCH-Behandlung im Vergleich zum Placebo zur Schmerzlinderung
- Nominell signifikante Verbesserungen in der Bewertung durch den Ermittler, der Knotenhärte und der Knotenstabilität
- Ein Sicherheitsprofil, das mit früheren CCH-Studien übereinstimmt
Die retrospektive Analyse von 2.273 Patientenakten ergab, dass fast zwei Drittel der Patienten über Fußschmerzen berichteten, wobei 90% diese als moderat oder schwer beschrieben. Derzeit rekrutiert Endo Patienten für eine Phase-3-Studie, um CCH als potenzielle nicht-chirurgische Behandlungsoption für Plantarfibromatose weiter zu erkunden.
- Phase 2 study showed a trend in CCH treatment effect over placebo for reducing pain in plantar fibromatosis patients
- Nominally significant improvements observed in investigator assessment, nodular hardness, and nodule consistency scales
- CCH safety profile consistent with known profile from other clinical studies and indications
- Endo is advancing to Phase 3 clinical study for CCH in plantar fibromatosis treatment
- CCH is not yet approved for use in treating patients with plantar fibromatosis
- 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
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
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
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SOURCE Endo, Inc.
FAQ
What were the key findings of Endo's Phase 2 study on CCH for plantar fibromatosis presented at APMA 2024?
Is Endo (NDOI) conducting a Phase 3 study for CCH in plantar fibromatosis treatment?
What did the retrospective analysis of plantar fibromatosis patients reveal at the APMA 2024 meeting?
Is collagenase clostridium histolyticum (CCH) approved for treating plantar fibromatosis as of August 2024?
