Pacira BioSciences, Inc. (PCRX), Monday announced two year positive efficacy data from locally administered gene therapy candidate PCRX-201 that provided sustained improvements in knee pain, stiffness, and function for up to two years. The non-opioid pain therapies provider said the results of a single local injection in patients with mild, moderate, and severe osteoarthritis of the knee, regardless of the severity of the condition, provided promise of improvements.
The company presented a poster session of the data at the 2025 Osteoarthritis Research Society International in April last week.
The open-label, phase 1 trial investigated the efficacy of PCRX-201 administered by ultrasound-guided intraarticular injection in 72 patients, aged 30 to 80. Patients in the corticosteroid -pretreated cohort achieved 48-65 percent reductions in pain and 53-72 percent reductions in stiffness.
According to Pacira BioSciences, PCRX-201 design is based on its proprietary high-capacity adenovirus, or HCAd, gene therapy vector platform. It is injected locally into the knee joint to boost cellular production of interleukin-1 receptor antagonist, and block interleukin-1 pathway activation to improve chronic inflammation, pain, and function.
Lead investigator and primary author on the poster presentation Ali Mobasheri said, "The power of PCRX-201 is that it targets much more than the symptoms of osteoarthritis, it addresses the root cause by targeting the inflammatory endotype and chronic inflammation at the cellular level with a locally administered genetic medicine that that mimics the body's natural inflammatory response."
The company is planning to advance to Phase 2 study of PCRX-201 and dosing is underway. In March 2024, the therapy has received Regenerative Medicine Advanced Therapy designation from the U.S. Food and Drug Administration.
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