Organogenesis announces development program update for ReNu

Organogenesis announced a development program update for ReNu, a cryopreserved amniotic suspension allograft, or ASA, for the management of symptoms associated with knee osteoarthritis, or OA. Organogenesis completed a Type-B meeting with the FDA on July 25. 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. Additionally, subgroup data analysis revealed that the most severe patients treated with ReNu responded with similar reductions in pain to those patients with moderate disease, supporting the top line results. As previously announced, the first Phase 3 randomized clinical trial achieved the pre-defined requirements for study success – statistically significant reduction in knee pain and statistically significant maintenance of function, at six months. Additional sensitivity analysis showed that subjects in the saline group took substantially more acetaminophen for break through pain during the study.