Precigen Announces Long-Term Follow-Up Results Highlighting Ongoing Durable Complete Responses after Treatment with PAPZIMEOS, the First and Only FDA-approved Therapy for Adults with Recurrent Respiratory Papillomatosis

Core Insights - Precigen, Inc. announced long-term follow-up data showing durable responses to PAPZIMEOS (zopapogene imadenovec-drba) for adults with recurrent respiratory papillomatosis (RRP), presented at the AAO-HNSF 2025 Annual Meeting [1][3] - PAPZIMEOS is the first and only FDA-approved therapy for RRP, granted full approval in August 2025 [1][7] Efficacy and Safety - The pivotal study for PAPZIMEOS met primary safety and efficacy endpoints, with 51% of patients achieving complete response, requiring no surgeries in the 12 months post-treatment [2][5] - Long-term follow-up data indicated that 83% of complete responders maintained their response with a median follow-up of 36 months, and no new safety events were observed [5][6] Impact on Patients and Healthcare System - Durable responses from PAPZIMEOS lead to fewer surgical procedures, reducing complications and long-term healthcare burdens [3] - The percentage of patients experiencing a reduction in surgeries compared to the year prior to treatment was 86% in Year 1, 91% in Year 2, and 95% in Year 3 [5][6] Background on RRP - RRP is a rare disease caused by chronic HPV 6 or HPV 11 infection, leading to severe complications and requiring repeated surgeries, which can significantly impact patients' quality of life [4] - Approximately 27,000 adult RRP patients are estimated to be in the US, highlighting the unmet medical need for effective treatments [4]