Pacira BioSciences announced Phase 1 data for its gene therapy candidate PCRX-201 (enekinragene inzadenovec) at the 2025 European Alliance of Associations for Rheumatology (EULAR) Annual Congress. The data demonstrates the therapy’s safety and sustained clinical benefits in patients with moderate-to-severe knee osteoarthritis for three years following a single injection. This presentation highlights the potential of PCRX-201 as a long-term, non-opioid solution for osteoarthritis pain management.
This news is particularly relevant given the large number of individuals affected by osteoarthritis and the limited long-term treatment options currently available. The sustained three-year efficacy data reinforces the potential of PCRX-201 to address a significant unmet medical need, offering hope for long-lasting pain relief without the risks associated with opioid medications. This advancement could significantly improve the quality of life for millions suffering from this debilitating condition.
PCRX-201 utilizes Pacira’s proprietary high-capacity adenovirus vector platform. The therapy targets the chronic inflammatory processes underlying osteoarthritis of the knee. Previous data revealed sustained improvements in pain, stiffness, and function through two years. The therapy has received both Regenerative Medicine Advanced Therapy (RMAT) and Advanced Therapy Medicinal Products (ATMP) designations. Building upon the positive Phase 1 results, a Phase 2 study (the ASCEND study) is currently underway.
This continued positive data readout for PCRX-201 strengthens its position as a potential game-changer in osteoarthritis treatment. The three-year data reinforces the potential for long-term efficacy, offering a significant advancement over current treatment paradigms. The ongoing Phase 2 trial will be crucial in further validating these findings and paving the way for potential regulatory approval and eventual commercialization, ultimately transforming the landscape of osteoarthritis care.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
