Pacira BioSciences Announces First Patient Dosed in Phase 2 Study Evaluating Safety and Efficacy of PCRX-201 for the Treatment of Osteoarthritis of the Knee

Core Viewpoint - Pacira BioSciences has initiated the Phase 2 ASCEND study for PCRX-201, a novel gene therapy aimed at treating knee osteoarthritis by enhancing the production of the anti-inflammatory protein IL-1Ra [1][2][8] Company Overview - Pacira BioSciences is focused on delivering innovative, non-opioid pain therapies, with a commitment to transforming patient lives [1][10] - The company has three commercial-stage non-opioid treatments: EXPAREL, ZILRETTA, and iovera° [10] Study Design - The ASCEND study is a two-part, multicenter trial involving approximately 135 patients aged 45 to 80 with painful knee osteoarthritis [3][5] - Patients will be randomized into treatment groups receiving either PCRX-201 or saline, with two different doses being evaluated [4][6] Drug Details - PCRX-201 is based on a proprietary high-capacity adenovirus vector platform, designed for local administration to target chronic inflammation in knee osteoarthritis [7][12] - The therapy aims to provide sustained pain relief and improve function, with previous Phase 1 results showing effects lasting up to two years [2][8] Regulatory Designations - PCRX-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Advanced Therapy Medicinal Products (ATMP) designation from the EMA, indicating its potential to address significant unmet medical needs [8] Manufacturing and Scalability - The drug product for Part B of the study will utilize a newly developed suspension-based batch manufacturing process, aimed at commercial scale-up [5] - The high-capacity adenovirus vector platform allows for efficient gene delivery and the potential for cost-effective production of therapies [12]