Pacira BioSciences (NASDAQ: PCRX) announced it has transitioned its investigational gene therapy PCRX-201 (enekinragene inzadenovec) to a U.S.-based scalable commercial manufacturing process, enabling enrollment of the first patient in Part B of its Phase 2 ASCEND study.

PCRX-201 is being studied as a locally administered gene therapy for osteoarthritis of the knee. The manufacturing transition was completed without delaying the ongoing Phase 2 program, according to the company. Enrollment in Part A of the ASCEND study concluded in June 2026, with topline data expected by the end of 2026.

The ASCEND study is a two-part, multicenter trial targeting approximately 135 patients between the ages of 45 and 80 with painful osteoarthritis of the knee. Part A randomized 49 patients, while Part B will randomize approximately 90 patients. The study evaluates two doses of PCRX-201 against a saline control, with a primary endpoint measuring treatment-emergent adverse events through 52 weeks. Secondary endpoints include changes in pain and physical function at weeks 38 and 52. All participants will be followed for five years.

"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," said Frank D. Lee, chief executive officer of Pacira BioSciences.

Chief Medical Officer Jonathan Slonin, MD, MBA, noted the study's development included collaboration with the Brendan Lee Lab at Baylor College of Medicine.

PCRX-201 holds Regenerative Medicine Advanced Therapy designation from the U.S. Food and Drug Administration and Advanced Therapy Medicinal Products designation from the European Medicines Agency. The therapy is based on Pacira's proprietary high-capacity adenovirus vector platform.

The information in this article is based on a press release statement from Pacira BioSciences.