Pacira(US:PCRX)2025-04-25 23:53PCRX-201 Overview - PCRX-201 is an innovative, locally-administered gene therapy targeting the underlying cause of osteoarthritis (OA)[1, 10] - It offers unprecedented pain relief and durability for at least 2 years from a single injection across all levels of disease severity[11] - Phase 1 trial data showed a 48-65% reduction from baseline pain through 104 weeks[13] - In the Phase 1 trial, over 70% of patients experienced a greater than 50% improvement in pain and stiffness vs baseline at week 16 and 78[15] Clinical Development Plan - The company plans a clinical development pathway including Phase 2 Part A, Phase 2 Part B, Phase 2 Bilateral Dosing, Phase 3 Single Injection, and Phase 3 Extension with repeat dosing, targeting a BLA submission by 2032[17, 19] Phase 2 Study Design - The Phase 2 study is a two-part, randomized, double-blind, active-controlled study to assess the safety and tolerability of PCRX-201 in subjects with painful knee OA[20, 22] - Part A will use existing inventory from the Phase 1 trial, while Part B will use a new manufacturing process intended for commercial scale-up[28] - Both parts will pretreat all subjects with a 40 mg intra-articular (IA) dose of methylprednisolone acetate[28, 40, 43] - Part A plans for a maximum of 45 subjects (15 per group), and Part B plans for 90 subjects (30 per group)[32, 39, 42]