Pacira Presents 104-Week Safety and Efficacy Data for PCRX-201 in Knee Osteoarthritis

Pacira BioSciences, Inc. (NASDAQ: PCRX), renowned for its innovative non-opioid pain therapies, will present new data supporting its gene therapy candidate, PCRX-201 (enekinragene inzadenovec), at the American College of Rheumatology’s ACR Convergence meeting in Washington, D.C., scheduled for November 14–19. The poster, titled "Sustained Clinical Effects After a Single Intra-articular Injection of PCRX-201 for Moderate-to-Severe Osteoarthritis of the Knee," will be presented by Dr. Stanley Cohen, a board-certified rheumatologist and Co-Medical Director of the Metroplex Clinical Research Center in Dallas, TX, on Sunday, November 17, from 10:30 am to 12:30 pm EST.

PCRX-201 is designed as a locally administered gene therapy that produces interleukin-1 receptor antagonist (IL-1Ra), an anti-inflammatory protein that curtails interleukin-1 (IL-1) signaling, a significant factor in the onset and progression of knee osteoarthritis. Unlike systemic gene therapies, PCRX-201 targets the affected area directly, using an inducible promoter to activate IL-1Ra production in response to joint inflammation. This mechanism aims to alleviate pain, reduce disability, and potentially slow the disease's structural progression.

In March 2024, PCRX-201 achieved a significant milestone by becoming the first gene therapy candidate for osteoarthritis to receive Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA). This designation offers several advantages, including intensified FDA guidance on rapid drug development, early discussions about surrogate or intermediate endpoints, potential pathways for accelerated approval, priority review of the Biologics License Application (BLA), and other opportunities to expedite the development and review process. Additionally, in May 2023, PCRX-201 was granted Advanced Therapy Medicinal Products (ATMP) designation by the European Medicines Agency.

Pacira BioSciences focuses on delivering non-opioid pain therapies that significantly impact patient lives. The company markets three commercial-stage non-opioid treatments:

1. **EXPAREL® (bupivacaine liposome injectable suspension)**: A long-acting local analgesic approved for infiltration, fascial plane block, and interscalene brachial plexus nerve block for managing post-surgical pain.
2. **ZILRETTA® (triamcinolone acetonide extended-release injectable suspension)**: An extended-release, intra-articular injection for managing osteoarthritis knee pain.
3. **ioveraº®**: A handheld device providing immediate, long-lasting, drug-free pain relief through precise, controlled cold temperature doses to a targeted nerve.

Pacira is also advancing PCRX-201, aiming to treat prevalent conditions like osteoarthritis with novel, locally administered gene therapies.