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Pacira BioSciences Presents New Data on the Effects of Clinical Immunogenicity on Locally Administered PCRX-201 in Patients with Moderate to Severe Osteoarthritis of the Knee
PaciraPacira(US:PCRX) Globenewswire·2025-05-15 12:00

Core Insights - Preliminary data indicates that pre-existing and treatment-induced anti-Ad5 neutralizing antibodies do not affect the safety and effectiveness of PCRX-201 for knee osteoarthritis [1][2][4] - The findings will be presented at the ASGCT Annual Meeting, highlighting the potential of PCRX-201 as a durable treatment option for knee osteoarthritis [1][2] Company Overview - Pacira BioSciences, Inc. is focused on innovative, non-opioid pain therapies, with PCRX-201 being a key candidate for treating knee osteoarthritis [1][11] - The company has received RMAT designation from the FDA for PCRX-201, which facilitates efficient drug development and potential accelerated approval [6][7][10] Study Details - An open-label, phase 1 trial involved 72 participants aged 30 to 80, assessing the impact of anti-Ad5 neutralizing antibodies on PCRX-201 [3] - The study measured NAb titers and IL-1Ra levels over 52 weeks, with results showing no adverse effects on efficacy or safety across different dosing levels [4][5] Treatment Efficacy - All doses of PCRX-201 led to improvements in knee pain, stiffness, and function, as measured by WOMAC-A and WOMAC-B indices [4] - Corticosteroid pretreatment was found to reduce treatment-induced NAb titers and related knee swelling [5] Future Developments - A Phase 2 study (ASCEND study) is currently underway for PCRX-201, building on the promising Phase 1 results [8] - The innovative design of PCRX-201 utilizes a high-capacity adenovirus vector platform to enhance treatment efficacy for chronic inflammation in knee osteoarthritis [2][9]