Press release
Organogenesis Shares ReNu® Program Update
On track to submit ReNu BLA by the end of 2025Enrollment in second Phase 3 complete; significantly ahead of expectationsSubgroup analysis demonstrated most
About this update from Organogenesis Holdings Inc.
[{"type":"text","content":"On track to submit ReNu BLA by the end of 2025Enrollment in second Phase 3 complete; significantly ahead of expectationsSubgroup 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 r...