Organogenesis Reports Positive Interim Analysis of Second Phase 3 Clinical Trial of ReNu for Knee Osteoarthritis
Organogenesis Holdings (ORGO) announced positive interim analysis results from its second Phase 3 clinical trial of ReNu for knee osteoarthritis treatment. The analysis, covering 50% of 474 planned patients with moderate to severe knee OA, focused on the 6-month primary endpoint. The independent Data Monitoring Committee recommended proceeding without modifications or sample size increases, confirming favorable results and consistent safety profile. The fully enrolled 594-patient trial is evaluating ReNu versus saline control through intra-articular injection, with the primary endpoint measuring knee pain reduction using the WOMAC pain scale. Knee OA affects nearly 31.1 million Americans, projected to reach 34.4 million by 2027.
Organogenesis Holdings (ORGO) ha annunciato risultati positivi dall'analisi intermedia del suo secondo trial clinico di Fase 3 per il trattamento dell'ReNu nell'osteoartrite del ginocchio. L'analisi, che ha coperto il 50% dei 474 pazienti pianificati con osteoartrite del ginocchio di grado moderato-severo, si è concentrata sull'obiettivo primario a 6 mesi. Il Comitato indipendente di Monitoraggio dei Dati ha raccomandato di procedere senza modifiche o aumenti della dimensione del campione, confermando risultati favorevoli e un profilo di sicurezza coerente. Lo studio, completamente arruolato con 594 pazienti, sta valutando ReNu rispetto al controllo salino attraverso iniezioni intra-articolari, con l'obiettivo primario che misura la riduzione del dolore al ginocchio utilizzando la scala del dolore WOMAC. L'osteoartrite del ginocchio colpisce quasi 31,1 milioni di americani, con previsioni che raggiungeranno i 34,4 milioni entro il 2027.
Organogenesis Holdings (ORGO) anunció resultados positivos del análisis intermedio de su segundo ensayo clínico de Fase 3 para el tratamiento del ReNu en la osteoartritis de rodilla. El análisis, que abarcó el 50% de los 474 pacientes planeados con osteoartritis de rodilla de moderada a severa, se centró en el objetivo primario a 6 meses. El Comité Independiente de Monitoreo de Datos recomendó continuar sin modificaciones ni aumento del tamaño de la muestra, confirmando resultados favorables y un perfil de seguridad consistente. El ensayo, completamente inscrito con 594 pacientes, está evaluando ReNu frente al control salino a través de inyección intraarticular, con el objetivo primario que mide la reducción del dolor de rodilla utilizando la escala de dolor WOMAC. La osteoartritis de rodilla afecta a casi 31,1 millones de estadounidenses, proyectándose que alcanzará los 34,4 millones para 2027.
Organogenesis Holdings (ORGO)은 무릎 골관절염 치료를 위한 ReNu의 두 번째 3상 임상 시험에서 긍정적인 중간 분석 결과를 발표했습니다. 이 분석은 중등도에서 중증의 무릎 OA 환자 474명의 50%를 대상으로 하였으며, 6개월의 주요 평가 지점에 초점을 맞추었습니다. 독립 데이터 모니터링 위원회는 수정이나 샘플 크기 증가 없이 진행할 것을 권장하며, 유리한 결과와 일관된 안전성 프로파일을 확인했습니다. 완전 등록된 594명 환자를 대상으로 한 이 시험은 ReNu와 생리식염수 대조군을 관절 내 주사를 통해 평가하고 있으며, 주요 평가 지점은 WOMAC 통증 척도를 사용하여 무릎 통증 감소를 측정합니다. 무릎 OA는 거의 3,110만 미국인에게 영향을 미치며, 2027년까지 3,440만에 이를 것으로 예상됩니다.
Organogenesis Holdings (ORGO) a annoncé des résultats positifs de l'analyse intermédiaire de son deuxième essai clinique de phase 3 pour le traitement de l'ReNu dans l'arthrose du genou. L'analyse, portant sur 50 % des 474 patients prévus souffrant d'arthrose du genou modérée à sévère, s'est concentrée sur le critère principal de 6 mois. Le Comité Indépendant de Surveillance des Données a recommandé de poursuivre sans modifications ni augmentation de la taille de l'échantillon, confirmant des résultats favorables et un profil de sécurité cohérent. L'essai, entièrement enregistré avec 594 patients, évalue ReNu par rapport au contrôle saline par injection intra-articulaire, le critère principal mesurant la réduction de la douleur au genou à l'aide de l'échelle de douleur WOMAC. L'arthrose du genou touche près de 31,1 millions d'Américains, un chiffre qui devrait atteindre 34,4 millions d'ici 2027.
Organogenesis Holdings (ORGO) hat positive Zwischenanalysen aus seiner zweiten Phase-3-Studie zu ReNu zur Behandlung von Kniearthrose angekündigt. Die Analyse, die 50% der geplanten 474 Patienten mit moderater bis schwerer Knie-OA umfasste, konzentrierte sich auf den primären Endpunkt von 6 Monaten. Das unabhängige Data Monitoring Committee empfahl, ohne Änderungen oder Erhöhung der Fallzahl fortzufahren, und bestätigte somit positive Ergebnisse und ein konsistentes Sicherheitsprofil. Die vollständig eingeschriebene Studie mit 594 Patienten bewertet ReNu im Vergleich zu einer Kochsalzlösung durch intraartikuläre Injektion, wobei der primäre Endpunkt die Reduktion von Knieschmerzen mit der WOMAC-Skala misst. Knie-OA betrifft fast 31,1 Millionen Amerikaner und wird voraussichtlich bis 2027 auf 34,4 Millionen ansteigen.
- Positive interim analysis results for Phase 3 trial
- Trial to proceed without modifications, indicating strong preliminary data
- Safety profile consistent with known ReNu data
- Study fully enrolled with 594 patients, exceeding planned 474
- None.
Insights
The interim analysis of ORGO's second Phase 3 trial for ReNu shows significant promise in the knee osteoarthritis market. The trial's continuation without modification suggests strong efficacy signals, aligning with pre-specified statistical parameters. The fully enrolled study of 594 patients surpasses the planned 474 patients, enhancing statistical power.
The addressable market is substantial, targeting 31.1 million Americans with knee OA, projected to reach 34.4 million by 2027. ReNu's positioning as a non-surgical intervention could capture significant market share, particularly for patients seeking alternatives to total knee replacement. The positive safety profile and DMC's endorsement substantially de-risk the development program.
This positive interim analysis significantly strengthens ORGO's market position in the regenerative medicine space. The knee OA market represents a massive revenue opportunity, with current treatments often to pain management or eventual surgery. A successful Phase 3 completion could position ReNu as a breakthrough therapy, potentially driving substantial revenue growth.
The robust trial design and positive interim results reduce development risk and enhance the probability of FDA approval. This could translate to increased institutional investor interest and potential partnership opportunities. The company's focus on both wound care and sports medicine markets provides diversified revenue streams, with ReNu potentially becoming a major growth driver.
CANTON, Mass., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced the favorable outcome of the interim analysis of its second Phase 3 randomized control trial of ReNu, a cryopreserved amniotic suspension allograft (ASA), for the management of symptoms associated with knee osteoarthritis (OA).
The pre-specified interim analysis on
“We have passed another critical milestone in the ReNu development program,” said Patrick Bilbo, Chief Operating Officer of Organogenesis. “We are pleased with the outcome of the interim analysis which indicates the study is in the favorable zone and consistent with the assumptions for the statistical plan and efficacy expectations.”
The fully enrolled 594 patient Phase 3 trial is a prospective, double-blind, multicenter, saline-controlled, parallel group, randomized control trial (RCT) of ReNu ASA, for the treatment of subjects with moderate to severe symptomatic knee OA. Patients were randomized to receive a single intra-articular (IA) injection of either saline control or ReNu. The primary endpoint is the reduction in knee pain assessed by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scale performed on subjects treated with ReNu or saline.
“We are pleased with the progression of this second Phase 3 clinical trial,” said Adam B. Yanke, MD, PhD, Associate Professor of Orthopedics and Vice Chair of Research at Rush University Medical Center, and Co-Principal Investigator of the trial. “Based on our progress to date, we are encouraged that the results of this study, when complete, will further strengthen the clinical evidence supporting ReNu as a safe and effective non-surgical treatment option for patients suffering from knee OA pain.”
Knee OA is a degenerative joint disease that is estimated to affect nearly 31.1 million Americans and projected to grow to 34.4 million Americans by 2027. It is ranked among the most common causes of disability and poor quality of life, generally characterized by pain and functionality deficits. End stage management of the disease in these patients is typically a total knee replacement when all other treatment options are exhausted.
About Organogenesis Holdings Inc.
Organogenesis Holdings Inc. is a leading regenerative medicine company focused on the development, manufacture, and commercialization of solutions for the advanced wound care and surgical and sports medicine markets. Organogenesis offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care.
Forward-Looking Statements
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified by the use of words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements concern, and these risks and uncertainties include, among others: the risks and uncertainties inherent in clinical development; that interim results are not necessarily indicative of final results; that other clinical trials of ReNu may produce different results; the likelihood and timing of possible regulatory approval and commercial launch of ReNu; determinations by regulatory and administrative governmental authorities which may delay or restrict our ability to develop or commercialize ReNu; ongoing regulatory obligations and oversight impacting ReNu; unforeseen safety issues resulting from the administration of ReNu in patients; competing products and product candidates that may be superior to our products and product candidates; uncertainty of market acceptance and commercial success of ReNu and the impact of studies (whether conducted by us or others and whether mandated or voluntary) on the commercial success of ReNu; our ability to manufacture and manage supply components for ReNu; the availability and extent of reimbursement of ReNu from third-party payers, including private payer healthcare and insurance programs and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers, including local coverage determinations by Medicare Part A/B Medicare Administrative Contractors; new policies and procedures adopted by such payers; unanticipated expenses; the costs of developing, producing, and selling ReNu; our ability to meet our sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; and other risks and uncertainties described in the Company's filings with the Securities and Exchange Commission, including Item 1A (Risk Factors) of the Company's Form 10-K for the year ended December 31, 2023 and its subsequently filed periodic reports. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.
FAQ
What were the results of ORGO's ReNu Phase 3 interim analysis for knee osteoarthritis?
How many patients are enrolled in ORGO's ReNu Phase 3 trial for knee osteoarthritis?
What is the market potential for ORGO's ReNu treatment in knee osteoarthritis?
What is the primary endpoint in ORGO's ReNu Phase 3 trial?
