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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
-- Novel, locally administered gene therapy designed to boost cellular production of anti-inflammatory protein IL-1Ra in the knee -- -- Initial topline
About this update from Pacira Biosciences, Inc.
[{"type":"text","content":"-- Novel, locally administered gene therapy designed to boost cellular production of anti-inflammatory protein IL-1Ra in the knee -- -- Initial topline results from two-part, randomized, double-blind, active-controlled study expected late 2026 -- BRISBANE, Calif., April 03, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced the first patient has been dosed in the Phase 2 ASCEND study of PCRX-201 (enekinragene inzadenovec) for the treatment of osteoarthritis, or OA, of the knee. PCRX-201 features an innovative design based on the company’s 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 (IL-1Ra), and block interleukin-1 pathway activation to improve chronic inflammation, pain, and function. PCRX-201’s unique design also features an inducible promoter to mimic the body’s natural response to inflammation by “turning on” the expression of IL-1Ra when inflammation is present in the joint and turning off expression once inflammation is quelled. “We are excited to advance PCRX-201 into Phase 2 clinical development as it marks an important milestone on our 5x30 path to growth and value creation, as well as our transition into an innovative biopharmaceutical organization,” said Frank D. Lee, chief executive officer of Pacira. “There is a significant need for innovation in the treatment of OA of the knee, as current therapies are based on decades-old mechanisms and only provide up to three to six months of relief. In our large Phase 1 study, a single intra-articular injection of PCRX-201 was well tolerated and demonstrated unprecedented pain relief and durability across all levels of OA severity for at least two years. PCRX-201 has the potential to address the underlying chronic inflammatory processes that contribute to OA joint degeneration over time, with local administration that is contained in the joint – delivering medicine where it matters.” Study Design The two-part, multicenter ASCEND study will involve approximately 135 patients, 45 to 80 years old with painful OA of the knee at a Kellgren-Lawrence (K-L) Grade of 2, 3 or 4. Subjects will be r...