Organogenesis Shares ReNu® Program Update
Organogenesis Holdings Inc. (Nasdaq: ORGO) has provided an update on its ReNu® development program for knee osteoarthritis (OA) symptoms. The company is on track to submit a Biologics License Application (BLA) by the end of 2025. Enrollment in the second Phase 3 trial has been completed ahead of schedule, with 594 patients. Subgroup analysis showed that severe (KL4) patients responded similarly to moderate (KL3) cases.
Key points:
- FDA indicated a second Phase 3 study was needed for BLA submission
- Combined Phase 3 studies will evaluate over 1,100 patients
- First Phase 3 trial showed statistically significant pain reduction and function maintenance
- ReNu could address unmet needs for all knee OA patients, including severe cases
Organogenesis Holdings Inc. (Nasdaq: ORGO) ha fornito un aggiornamento sul suo programma di sviluppo ReNu® per i sintomi dell'osteoartrite (OA) del ginocchio. L'azienda è in programma di presentare una domanda di licenza biologica (BLA) entro la fine del 2025. L'arruolamento nel secondo studio di Fase 3 è stato completato con anticipo, con 594 pazienti. L'analisi dei sottogruppi ha mostrato che i pazienti severi (KL4) hanno risposto in modo simile ai casi moderati (KL3).
Punti chiave:
- La FDA ha indicato che era necessario un secondo studio di Fase 3 per la presentazione della BLA
- Gli studi combinati di Fase 3 valuteranno oltre 1.100 pazienti
- Il primo studio di Fase 3 ha mostrato una riduzione statisticamente significativa del dolore e un mantenimento della funzionalità
- ReNu potrebbe affrontare esigenze insoddisfatte per tutti i pazienti con OA al ginocchio, comprese le forme gravi
Organogenesis Holdings Inc. (Nasdaq: ORGO) ha proporcionado una actualización sobre su programa de desarrollo ReNu® para los síntomas de osteoartritis (OA) de rodilla. La compañía está en camino de presentar una Solicitud de Licencia Biológica (BLA) a finales de 2025. La inscripción en el segundo ensayo de fase 3 se completó antes de lo programado, con 594 pacientes. El análisis de subgrupos mostró que los pacientes severos (KL4) respondieron de manera similar a los casos moderados (KL3).
Puntos clave:
- La FDA indicó que se necesitaba un segundo estudio de fase 3 para la presentación de la BLA
- Los estudios combinados de fase 3 evaluarán a más de 1,100 pacientes
- El primer ensayo de fase 3 mostró una reducción estadísticamente significativa del dolor y un mantenimiento de la función
- ReNu podría cubrir necesidades insatisfechas para todos los pacientes con OA de rodilla, incluidos los casos severos
Organogenesis Holdings Inc. (Nasdaq: ORGO)는 무릎 골관절염(OA) 증상에 대한 ReNu® 개발 프로그램의 업데이트를 제공했습니다. 이 회사는 2025년 말까지 생물학적 라이선스 신청(BLA)을 제출할 예정입니다. 두 번째 3상 시험의 환자 모집이 예정보다 빨리 완료되어 594명이 참여했습니다. 하위 그룹 분석에 따르면, 중증(KL4) 환자들이 중등도(KL3) 사례와 유사하게 반응했습니다.
주요 포인트:
- FDA는 BLA 제출을 위해 두 번째 3상 연구가 필요하다고 밝혔습니다
- 결합된 3상 연구에서 1,100명 이상의 환자를 평가할 것입니다
- 첫 번째 3상 시험은 통계적으로 유의미한 통증 감소와 기능 유지를 보여주었습니다
- ReNu는 모든 무릎 OA 환자의 unmet needs를 해결할 수 있습니다, 중증 사례 포함
Organogenesis Holdings Inc. (Nasdaq: ORGO) a fourni une mise à jour sur son programme de développement ReNu® pour les symptômes de l'arthrose (OA) du genou. L'entreprise est sur le point de soumettre une Demande de Licence Biologique (BLA) d'ici fin 2025. L'inscription au deuxième essai de Phase 3 a été complétée en avance, avec 594 patients. L'analyse des sous-groupes a montré que les patients sévères (KL4) ont répondu de manière similaire aux cas modérés (KL3).
Points clés :
- La FDA a indiqué qu'une deuxième étude de Phase 3 était nécessaire pour la soumission de la BLA
- Les études combinées de Phase 3 évalueront plus de 1 100 patients
- Le premier essai de Phase 3 a montré une réduction statistiquement significative de la douleur et un maintien de la fonction
- ReNu pourrait répondre à des besoins non satisfaits pour tous les patients atteints d'OA du genou, y compris les cas sévères
Organogenesis Holdings Inc. (Nasdaq: ORGO) hat ein Update zu seinem ReNu®-Entwicklungsprogramm für Symptome von Kniearthrose (OA) bereitgestellt. Das Unternehmen ist dabei, einen Antrag auf biologische Lizenz (BLA) bis Ende 2025 einzureichen. Die Rekrutierung in die zweite Phase 3-Studie wurde vorzeitig mit 594 Patienten abgeschlossen. Die Subgruppenanalyse zeigte, dass schwerwiegende (KL4) Patienten ähnlich auf moderate (KL3) Fälle reagierten.
Wichtige Punkte:
- Die FDA hat angegeben, dass eine zweite Phase 3-Studie für die Einreichung der BLA erforderlich sei
- Die kombinierten Phase 3-Studien werden über 1.100 Patienten evaluieren
- Die erste Phase 3-Studie zeigte eine statistisch signifikante Schmerzlinderung und Funktionsbeibehaltung
- ReNu könnte ungedeckte Bedürfnisse aller Knie-OA-Patienten, einschließlich schwerer Fälle, ansprechen
- Enrollment in second Phase 3 trial completed ahead of schedule with 594 patients
- On track to submit BLA by the end of 2025
- Subgroup analysis showed severe (KL4) patients responded similarly to moderate (KL3) cases
- First Phase 3 trial achieved statistically significant pain reduction (p=0.0177) and function maintenance (p<0.0001)
- Combined Phase 3 studies will evaluate over 1,100 patients, enhancing evidence robustness
- FDA requires a second Phase 3 study to support BLA submission, potentially extending the approval timeline
Insights
The ReNu® development program update from Organogenesis is highly significant for investors. The completion of enrollment in the second Phase 3 trial, ahead of expectations, demonstrates strong interest from clinicians and patients. This accelerated timeline could potentially lead to earlier market entry and revenue generation.
The subgroup analysis showing comparable responses in severe (KL4) and moderate (KL3) knee OA patients is particularly noteworthy. This expands ReNu's potential market to include approximately 15% of Americans with severe knee OA, addressing a critical unmet need. If approved, ReNu could become a first-line treatment for a broader patient population, potentially increasing market share and revenue potential.
The robust evidence package with over 1,100 patients across two Phase 3 trials strengthens the BLA submission, potentially increasing the likelihood of FDA approval. However, investors should note that the BLA submission is still over a year away and FDA approval is not guaranteed.
Organogenesis' ReNu® program update presents a positive outlook for the company's future financial performance. The accelerated enrollment in the second Phase 3 trial suggests strong market demand, which could translate to rapid adoption upon potential approval. This may lead to faster revenue growth in the Advanced Wound Care segment.
The expanded potential patient population, including severe knee OA cases, could significantly increase the addressable market. With non-surgical options for severe cases, ReNu could command premium pricing, potentially boosting profit margins. However, investors should consider that commercialization is still years away and substantial R&D expenses will continue until then.
The company's ability to outperform enrollment expectations demonstrates strong operational execution, which is a positive indicator for future clinical and commercial success. While the news is encouraging, it's important to balance optimism with the understanding that regulatory hurdles remain and the financial impact won't be immediate.
- On track to submit ReNu BLA by the end of 2025
- Enrollment in second Phase 3 complete; significantly ahead of expectations
- Subgroup analysis demonstrated most severe (KL4) subjects responded comparably to moderate (KL3)
CANTON, Mass., Aug. 08, 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 a development program update for ReNu®, a cryopreserved amniotic suspension allograft (ASA), for the management of symptoms associated with knee osteoarthritis (OA).
Organogenesis completed a Type-B meeting with the Food and Drug Administration (FDA) on July 25th. The FDA typically requires two well-controlled Phase 3 clinical trials to support regulatory approval. The FDA indicated that a second Phase 3 study would be needed to support BLA submission. Organogenesis recently completed enrollment in the second Phase 3 multi-center RCT evaluating the safety and efficacy of ReNu with 594 patients, significantly outperforming enrollment expectations. Based on the success of the first Phase 3 study and the completion of enrollment of the second study, Organogenesis expects to submit the BLA by the end of 2025.
“We are pleased with the progress we have made in the ReNu development program as the feedback we have received from our investigators along with the quick pace of enrollment suggests that clinicians and patients are eager for a non-surgical option for knee OA pain,” said Patrick Bilbo, Chief Operating Officer of Organogenesis. “The addition of our second clinical trial strengthens our position as the combined Phase 3 studies will increase the number of patients evaluated to more than 1,100, significantly enhancing the robustness of the evidence package for the BLA program and the evidence available to clinicians.”
Additionally, subgroup data analysis revealed that the most severe patients (Kellgren-Lawrence [KL] grade 4) treated with ReNu responded with similar reductions in pain to those patients with moderate disease (KL 3), supporting the top line results. As previously announced, the first Phase 3 randomized clinical trial (RCT) achieved the pre-defined requirements for study success - statistically significant reduction in knee pain (p=0.0177) and statistically significant maintenance of function (p<0.0001), at six months. Additional sensitivity analysis showed that subjects in the saline group took substantially more (
“We are pleased with the response of the most severe knee OA patients, who are unlikely to respond to non-surgical treatment,” continued Mr. Bilbo. “If approved, ReNu will have the unique opportunity to address a critical unmet medical need for all knee OA patients, including the most severe cases for whom non-surgical treatment options are very limited and which represent approximately
About Knee OA
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. Up to 15 percent of knee OA patients are classified as severe (Kellgren-Lawrence grade 4). End stage management of the disease in these patients is typically a total knee replacement when all other treatment options are exhausted.
About ReNu®
ReNu is a cryopreserved, amniotic suspension allograft (ASA) developed for the management of symptomatic knee osteoarthritis. ReNu consists of amniotic fluid cells and micronized amniotic membrane and contains cellular, growth factor, and extracellular matrix components. ReNu received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Knee OA in 2021.
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, including statements regarding our ReNu product. 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,” “if approved,” “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 our filings with the Securities and Exchange Commission, including Item 1A (Risk Factors) of our Form 10-K for the year ended December 31, 2023 and our 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 we may voluntarily do so from time to time, we undertake 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 is the expected timeline for Organogenesis (ORGO) to submit the ReNu BLA?
How many patients were enrolled in Organogenesis' (ORGO) second Phase 3 trial for ReNu?
What were the results of the subgroup analysis for severe knee OA patients treated with ReNu (ORGO)?
What were the primary outcomes of Organogenesis' (ORGO) first Phase 3 trial for ReNu?
