Pacira宣布PCRX-201完成商业化制造工艺切换并启动ASCEND二期Part B入组

Pacira BioSciences Advances PCRX-201 Development Program with Successful Transition to Scalable Commercial Manufacturing Process
— First patient enrolled in Part B of Phase 2 ASCEND study enabled by availability of drug product from new manufacturing process —
— Topline data from Part A of Phase 2 ASCEND study remains on track for end of year —
BRISBANE, Calif., July 27, 2026 (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 that it has successfully transitioned PCRX-201 (enekinragene inzadenovec), its investigational locally administered gene therapy for osteoarthritis of the knee, to a U.S.-based scalable commercial manufacturing process intended to support future registrational development and commercialization. With drug product from the new manufacturing process now available, the first patient has been enrolled in Part B of the Phase 2 ASCEND study. Enrollment in Part A of ASCEND concluded in June, with topline data expected by the end of 2026.
This milestone supports Pacira’s 5x30 growth strategy by advancing one of the company’s most promising pipeline programs while further demonstrating the scalability of the proprietary high-capacity adenovirus (HCAd) platform. Together with PCRX-201’s Regenerative Medicine Advanced Therapy (RMAT) designation and encouraging Phase 1 results, the manufacturing transition further supports the program’s progression toward late-stage development. Importantly, the manufacturing transition was completed without delaying the ongoing Phase 2 ASCEND program.
“Successfully incorporating our intended commercial manufacturing process into our Phase 2 ASCEND study represents an important milestone for the PCRX-201 development program and a testament to the clinical development and manufacturing capabilities of our team,” said Frank D. Lee, chief executive officer of Pacira BioSciences. “By generating controlled clinical data with product manufactured using our new process we expect to utilize in later-stage development and commercialization, we are reducing development risk, advancing operational readiness, and strengthening the foundation for potential future registrational studies.”
“Advancing Part B of the ASCEND study is an important step in evaluating the potential of this investigational gene therapy for patients living with osteoarthritis of the knee,” said Jonathan Slonin, MD, MBA, chief medical officer of Pacira BioSciences. “This milestone reflects years of rigorous scientific and clinical work, including the foundational collaboration with the Brendan Lee Lab at Baylor College of Medicine, whose expertise helped inform the development of this locally administered gene therapy approach.”
About the ASCEND Study
The two-part, multicenter ASCEND study will involve approximately 135 patients between the ages of 45-80 years old with painful OA of the knee and a Kellgren-Lawrence (K-L) Grade of 2, 3 or 4. The study is evaluating two doses of PCRX-201: Dose A (1.4 × 10¹⁰ genome copies [GC]) and Dose B (1.4 × 10¹¹ GC). Patients are randomized 1:1:1 to Dose A, Dose B or saline and stratified by K-L Grade, a semiquantitative method for evaluating the severity of OA on a scale of 0-4. All cohorts receive pretreatment with an intra-articular corticosteroid (methylprednisolone 40 mg) to improve tolerability and gene transfer, a common technique in gene therapy dosing.
Part A of the study randomized 49 patients, and Part B will randomize approximately 90 patients. The study’s primary endpoint is the number and percentage of treatment-emergent adverse events, adverse events of special interest, and serious adverse events for PCRX-201 plus steroid pretreatment versus saline plus steroid pretreatment from Week 1 through Week 52. Secondary and exploratory endpoints include efficacy assessments such as changes in pain and physical function from baseline at Weeks 38 and 52, measured by the Numerical Rating Scale (NRS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Knee Injury and Osteoarthritis Outcome Score (KOOS). Biomarkers, immunogenicity, biodistribution, and structural endpoints will also be evaluated. All participants will be followed for five years.
To learn more about the ASCEND study, visit clinicaltrials.gov.
About PCRX-201 (enekinragene inzadenovec)
PCRX-201 (enekinragene inzadenovec) features an innovative design based on the company’s proprietary high-capacity adenovirus vector platform. It is currently being studied as a potential treatment for the underlying biomechanical and inflammatory processes that lead to osteoarthritis of the knee, a condition that affects more than 15 million individuals in the U.S. today.
In June 2025, Pacira reported data from its ongoing clinical development program showing that PCRX-201 continues to demonstrate durable and clinically meaningful improvements in knee pain, stiffness, and function through three years following local administration, with a well-tolerated safety profile. PCRX-201 has received RMAT designation from the U.S. Food and Drug Administration and Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency. PCRX-201 is the first gene therapy to achieve these clinical results and earn these regulatory designations in osteoarthritis of the knee – a testament to its promise and potential.
Given the promising Phase 1 results, Phase 2 of the two-part multicenter ASCEND study for PCRX-201 is underway. To learn more about PCRX-201 and the company’s clinical development program, please visit www.Pacira.com
About the High-capacity Adenovirus Vector Platform
Pacira’s proprietary novel high-capacity adenovirus (HCAd) gene therapy vector platform solves many of the challenges in the field of gene therapy that have prevented its utilization in treating common diseases, such as osteoarthritis.
Key features include:
- The HCAd vector is much more efficient at delivering genes into cells compared to many other gene therapies that rely on adenovirus associated virus, or AAV, vectors. As a result, the desired effect can be achieved with much smaller doses.
- The vector used in the HCAd platform can carry up to 30,000 base pairs of DNA, which enables gene therapy with multiple or larger genes compared to AAV vectors.
- Genetic medicines based on the HCAd platform can be administered locally and have the potential for redosing at appropriate therapeutic intervals.
- Lower dose levels and efficient delivery of genes into cells means that thousands of doses can be produced in a single batch. As a result, therapies built on the HCAd platform are expected to have a commercially attractive and viable cost of goods profile.
Beyond PCRX-201, the company is evaluating several other HCAd product candidates.
About Pacira
Pacira delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa for postsurgical pain management; ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and iovera®º, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The company is also advancing a pipeline of clinical-stage assets for musculoskeletal pain and adjacencies. Its most advanced product candidate, PCRX-201 (enekinragene inzadenovec), is a novel locally administered gene therapy in Phase 2 clinical development for oste