Pacira BioSciences Concludes Patient Enrollment in Part A of Phase 2 Study Evaluating Safety and Efficacy of PCRX-201 for the Treatment of Osteoarthritis of the Knee

Core Insights - Pacira BioSciences has completed patient enrollment in Part A of its Phase 2 ASCEND study for PCRX-201, a novel gene therapy for knee osteoarthritis, with topline results expected by the end of 2026 [1][6][10] Study Overview - The ASCEND study is a two-part, multicenter trial involving approximately 135 patients aged 45 to 80 with painful knee osteoarthritis at Kellgren-Lawrence Grades 2, 3, or 4 [4] - Part A randomizes about 45 patients to evaluate two doses of PCRX-201, with a 1:1:1 randomization to Dose A, Dose B, or saline, all receiving corticosteroid pretreatment [5][6] - The primary endpoint includes treatment-emergent adverse events and secondary endpoints assess pain and physical function changes at Weeks 38 and 52 [7] Product Details - PCRX-201 is designed to enhance IL-1Ra production locally in the knee joint, targeting chronic inflammation and pain associated with osteoarthritis [2][9] - The therapy utilizes a high-capacity adenovirus vector platform, allowing for efficient gene delivery and the potential for redosing [12][17] - The product has received RMAT designation from the FDA and ATMP designation from the EMA, highlighting its clinical promise [11] Company Background - Pacira BioSciences focuses on innovative, non-opioid pain therapies, with existing products including EXPAREL, ZILRETTA, and iovera° [15] - The company aims to address prevalent diseases like osteoarthritis through advanced gene therapy solutions [15]