Persica 002 Phase 1b PP353 vs Placebo in the Treatment of Low Back Pain

Summary

A Phase 1b study to investigate the efficacy of PP353 compared to placebo in the treatment of chronic low back pain associated with bone oedema.

Timeline

Start

2020-01-20

Primary completion

2024-12-09

Completion

2024-12-09

Outcome

Met primary endpoint

registry analysis (superiority test); PP353 vs Placebo; p = 0.0284; Least Squares Mean difference -1.37; Mixed Models Analysis NCT04238676 ↗

Publications

• Results Tripathi SS, Sneath R, Golash A, Desai P, McHale D, Guest S, Brindley C, Cummings P, Smith S, Stroud C, Scott G, Ruston S, Czaplewski L. Pharmacokinetics of PP353, a formulation of linezolid for intervertebral disc administration, in patients with chronic low back pain and Modic change Type 1: A first-in-human, Phase 1b, open-label, single-dose study. JOR Spine. 2024 Nov 14;7(4):e70009. doi: 10.1002/jsp2.70009. eCollection 2024 Dec.
• Results Lassen MR, Scarborough M, Gilchrist N, Tripathi SS, Price C, Horcajadas A, DeAndres J, Baranidharan G, Ahuja S, Otte KS, Wood E, Guest S, Czaplewski LG, McHale D; Modic Trial (TMT) group. Intradiscal linezolid (PP353) treatment for chronic low back pain associated with Modic change type 1: an international, first-in-human, randomised, sham procedure-controlled, double-blind, phase 1b clinical trial. EClinicalMedicine. 2026 Feb 2;92:103764. doi: 10.1016/j.eclinm.2026.103764. eCollection 2026 Feb.

Drugs

Indications