Organogenesis Holdings Inc announced positive topline data from a phase 3 randomized control trial evaluating the safety and efficacy of ReNu for the management of knee osteoarthritis (OA) symptoms. Treatment with the drug, a cryopreserved amniotic suspension allograft (ASA), resulted in significant reductions in knee pain and significant maintenance of function at 6 months among a cohort of patients with knee OA.¹

The degenerative joint disease, which currently affects approximately 31 million Americans, is projected to increase to 34.4 million by 2027. It commonly presents as pain and functionality issues and is ranked among the top causes of disability and poor quality of life. Among these patients, up to 15% are diagnosed as severe (Kellgren-Lawrence [KL] grade 4), which in some cases can require total knee replacement.¹

“To date, non-surgical treatment options for severe OA patients (KL grade 4) are limited—which represented approximately 30% of the enrolled patient population for this study,” Adam B. Yanke, MD, PhD, Associate Professor of Orthopedics at Rush University Medical Center, a sports medicine and orthopedic surgeon and Co-Principal Investigator, stated. “These topline results provide statistically significant evidence that the use of ReNu is a safe, effective treatment option for knee OA patients, if approved.”¹

The Trial

The phase 3 prospective, double-blind, multicenter, saline-controlled, parallel group clinical trial included 515 patients with moderate to severe symptomatic knee OA, defined as KL grade 2—4. Patients were randomized to receive a single intra-articular injection of either ReNu (ASA) 2 mL diluted with 2 mL of saline or 4 mL saline (control). Reduction in knee OA pain was evaluated using the Western Ontario and McMaster Universities Arthritis Index pain scale.¹

At 6 months, patients treated with ReNu exhibited significant reductions in assessed knee pain (P = .0177) and maintained patient function (P < .0001) compared with controls. In addition to efficacy results, ReNu demonstrated a favorable safety profile consistent with previous studies, and similar rates of adverse events were reported through 12 months of follow up.¹

These data represent another positive step towards US Food and Drug Administration (FDA) approval of the drug, which had previously been granted the FDA Regenerative Medicine Advance Therapy (RMAT) designation for knee OA in January 2021. This designation is designed to expedite the development and review of regenerative therapies intended to treat, reverse, modify, or cure a serious disease or condition.²

The RMAT decision was based on positive clinical evidence from a 200-patient multicenter, single-blinded, randomized controlled trial in which patients with knee OA treated with ReNu exhibited significantly better reductions in pain and improvement in function when compared with hyaluronic acid and saline.²

“ReNu is supported by a robust and growing volume of scientific evidence,” Patrick Bilbo, Chief Operating Officer of Organogenesis, said in a statement. “Based on the positive results of this pivotal trial along with our accumulated safety and efficacy data, we now plan to request a meeting with the FDA to discuss the clinical data requirements for a Biologics License Application (BLA) filing. We look forward to having an update to share later this year and to initiating further studies to expand the potential clinical indications of ReNu.”¹

The complete analysis of the trial is expected later this month and a second multicenter clinical trial is actively recruiting patients with full enrollment expected this year.¹

References

1. ^{Organogenesis Inc. Organogenesis achieves primary endpoint in phase 3 clinical trial of ReNu® for knee osteoarthritis. GlobeNewswire News Room. May 2, 2024. Accessed May 2, 2024. https://www.globenewswire.com/news-release/2024/05/02/2874026/0/en/Organogenesis-Achieves-Primary-Endpoint-in-Phase-3-Clinical-Trial-of-ReNu-for-Knee-Osteoarthritis.html.}
2. ^{Organogenesis Renu® receives FDA Regenerative Medicine Advanced Therapy (RMAT) designation for osteoarthritis of the knee. January 11, 2021. Accessed May 2, 2024. https://organogenesis.com/news-events/press-release-01112021.html.}