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Abstract Number: 1184

Sustained Clinical Effects After a Single Intra-articular Injection of PCRX-201 for Moderate-to-Severe Osteoarthritis of the Knee

Stanley Cohen1, Philip G Conaghan2, Marc Hochberg3, Alan Kivitz4, Nino Joy5, Derek Jackson5, Masato Nakazawa5, Mary DiGiorgi5 and Jonathan Slonin5, 1Metroplex Clinical Research Center, dallas, TX, 2Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, 3University of Maryland School of Medicine, Baltimore, MD, 4Altoona Center for Clinical Research, Duncansville, PA, 5Pacira BioSciences, Inc., Tampa, FL

Meeting: ACR Convergence 2024

Keywords: clinical trial, gene therapy, Joint Structure, Osteoarthritis, WOMAC

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Session Information

Date: Sunday, November 17, 2024

Title: Osteoarthritis – Clinical Poster I

Session Type: Poster Session B

Session Time: 10:30AM-12:30PM

Background/Purpose: Osteoarthritis of the knee (OAK) is a common and severe disease. Current treatments provide temporary pain relief, demonstrating unmet need. PCRX-201 is a high capacity, nonintegrating, nonreplicating adenovirus serotype 5 vector for IA injection in patients with OAK. In response to local inflammation, PCRX-201 expresses interleukin-1 receptor antagonist, an inhibitor of interleukin-1 signaling, under control of an inducible promotor to reduce pain and disability and potentially slow structural progression. This open-label phase 1 trial (NCT04119687) investigated the safety and efficacy of PCRX-201 and is currently in long-term follow-up.

Methods: Participants aged 30-80 years (N=72) with OAK (Kellgren/Lawrence [K/L] grade 2-4) satisfying ACR criteria were eligible. The first cohort received ultrasound-guided IA injection of PCRX-201 in the target knee at 1 of 3 doses (n=36). To explore the benefit of immune modulation to maximize vector tolerability and transduction, the second cohort received pretreatment with IA methylprednisolone 40 mg immediately before PCRX-201 administration at the same doses (n=36). We report adverse events (AEs); efficacy outcomes, including WOMAC index pain score (WOMAC-A), stiffness score (WOMAC-B), and Knee Injury and Osteoarthritis Outcome Score (KOOS); and radiographic changes and MRI changes up to 104 weeks.

Results: No procedure- or treatment-related serious AEs were reported. Dose-related index knee effusion was the most commonly reported AE, occurring less frequently in the pretreated (13/36 [36%]) versus the not pretreated cohort (22/35 [63%]) as observed. Pain and function benefits were observed at all doses and across both cohorts, with the greatest improvements in the pretreated cohort (Figure 1); subsequent results focus on this cohort. In the pretreated cohort, the least squares mean (LSM) improvement from baseline was 3.3-4.4 of 10 points (48%-65%) for WOMAC-A (Figure 1A); and 3.7‑5.0 points (53%-72%) for WOMAC-B. LSM improvements from baseline in KOOS were similar (Figure 1B). Across doses in the pretreated cohort, pain response (defined as ≥50% reduction in WOMAC-A from baseline) was observed as early as 2-8 weeks after administration by >40% of participants and by 16 weeks in >70% of participants (Figure 2A). Participants in the pretreated cohort with K/L grade 3 or 4 had LSM reductions from baseline in WOMAC-A of 3.7 and 3.5 points, respectively (both 54% improvement), while those with K/L grade 2 had an LSM reduction of 5.5 points (81% improvement; Figure 2B). Structural assessment at week 104 demonstrated that disease progression with PCRX-201 did not differ significantly from expected natural progression; however, longer follow-up is needed.

Conclusion: A single IA injection of PCRX-201 in the index knee had an acceptable safety profile with improvements in pain across K/L grades to 104 weeks, indicating sustained clinical efficacy. From these data, future studies will employ steroid pretreatment. These results support further investigation of PCRX-201 in OAK in randomized, double-blind, active-controlled studies planned for 2025.

Supporting image 1

Figure 1. LSM change from baseline for (A) WOMAC-A pain and (B) KOOS across 3 doses in the pretreated cohort through week 104.

Supporting image 2

Figure 2. (A) LSM % responders for WOMAC-A pain across 3 doses and (B) LSM change from baseline for WOMAC-A pain across Kellgren/Lawrence grades through week 104 in the pretreated cohort.


Disclosures: S. Cohen: Amgen, 2, Pacira BioSciences, Inc., 5; P. Conaghan: AbbVie, 2, 6, Eupraxia Pharmaceuticals, 2, Galapagos, 2, Genascence, 2, Grünenthal, 2, GSK, 2, Janssen, 2, Levicept, 2, Lilly, 2, 6, Medipost, 2, Merck, 2, Moebius, 2, Novartis, 2, 6, Orion, 2, Pacira, 2, Sandoz, 6, Stryker, 2, Takeda, 2, TrialSpark, 2; M. Hochberg: Pacira BioSciences, Inc., 2; A. Kivitz: AbbVie, 2, 6, Amgen, 6, 11, Coval, 2, Ecor1, 2, Fresenius Kabi, 2, Genzyme, 12, Scientific ExpertGenzyme, Gilead, 2, 11, GlaxoSmithKlein (GSK), 2, 6, 11, Grunenthal, 2, Horizon, 2, Innovaderm, 2, Janssen, 2, Lilly, 6, Novartis, 11, Pfizer, 6, 11, Prime, 12, Educational, Prometheus, 2, Sanofi - Regeneron, 6, SynAct, 2, Takeda, 2, UCB, 2, 6, XBiotech, 2; N. Joy: Pacira BioSciences, Inc., 3, 11; D. Jackson: Pacira BioSciences, Inc., 3, 11; M. Nakazawa: Pacira BioSciences, Inc., 3, 11; M. DiGiorgi: Pacira BioSciences, Inc., 3, 11; J. Slonin: Pacira BioSciences, Inc., 3, 11.

To cite this abstract in AMA style:

Cohen S, Conaghan P, Hochberg M, Kivitz A, Joy N, Jackson D, Nakazawa M, DiGiorgi M, Slonin J. Sustained Clinical Effects After a Single Intra-articular Injection of PCRX-201 for Moderate-to-Severe Osteoarthritis of the Knee [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/sustained-clinical-effects-after-a-single-intra-articular-injection-of-pcrx-201-for-moderate-to-severe-osteoarthritis-of-the-knee/. Accessed .
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