Persica Pharmaceuticals Limited (Persica), a clinical stage pharmaceutical company developing an antibiotic formulation for intradiscal injection to treat chronic Low Back Pain (cLBP), recently announced the publication of two papers describing the preclinical development and First-in-Human pharmacokinetics of Persica’s asset, PP353, in the peer-reviewed Journal of Orthopaedic Research (JOR) Spine.
Dr Steve Ruston, Chief Executive Officer of Persica, said: “Chronic Low Back Pain is a debilitating condition that significantly affects quality of life for millions of people, many of whom are not helped by existing treatments, often resulting in long-term reliance on analgesics such as opioids to manage pain. The papers published this month in JOR Spine summarise our journey so far in the development of PP353, a ground-breaking therapy which could positively transform the lives of cLBP patients with Modic changes. We are looking forward to seeing the results from our Phase 1b Modic Trial which will be available in Q1 2025.”
Some cLBP patients have pathological changes in the vertebrae of the spine, described as Modic changes, which are visible on MRI scans. These Modic changes can be caused by a localised and chronic bacterial infection in the spinal discs between the vertebrae, which leads to prolonged and debilitating pain.
Persica’s work stems from the breakthrough findings from its founders who conducted a randomised, double-blind, placebo-controlled clinical trial1 which demonstrated that an oral antibiotic delivered over 100 days offered significant clinical benefit for a number of patients by treating the bacterial infection. Prolonged oral antibiotic therapy is poorly tolerated, however, and requires diligent compliance; moreover, its widespread use is precluded by the anticipated antibiotic resistance its adoption would bring.
The research published in JOR Spine describes the development of PP353, designed for intradiscal injection under image guidance to provide substantial antibiotic exposure at the infected site, thereby minimising side-effects and microbial resistance.
- The first paper, “Preclinical development and characterisation of PP353, a formulation of linezoid for intradiscal administration”, details the preclinical development of the asset
- The second paper, “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”, gives results from Part A of Persica’s Phase Ib Modic Trial, showing that PP353 was well tolerated with no serious adverse events in this open-label single-dose phase of the study
Results from Part B of the Phase Ib Modic Trial, a randomised, double-blind, placebo-controlled clinical trial assessing the safety and efficacy of PP353 as a treatment for patients with cLBP associated with Modic changes, are expected in Q1 2025.
Reference:
1 Albert HB, Sorensen JS, Christensen BS, Manniche C. Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy. Eur Spine J. 2013 Apr;22(4):697-707. doi: 10.1007/s00586-013-2675-y. Epub 2013 Feb 13. PMID: 23404353; PMCID: PMC3631045.
Source:
The papers published in JOR Spine
- Preclinical development and characterisation of PP353, a formulation of linezolid for intradiscal administration. Graham Hagger, Sarah Guest, Stephen Birchall, Alys Bradley, Charlie Brindley, David Corbett, Paul J. Cummings, Cristina Freire, James Harris, Andrew Wise, Melanie Wood, Lloyd G. Czaplewski JOR Spine https://doi.org/10.1002/jsp2.70010
- 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. Shiva S Tripathi, Robert Sneath, Aprajay Golash, Parag Desai, Duncan McHale, Sarah Guest, Charlie Brindley, Paul Cummings, Shane Smith, Conrad Stroud, Graham Scott, Steve Ruston, Lloyd Czaplewski. JOR Spine JOR Spine https://doi.org/10.1002/jsp2.70009
Image: ICR Healthcare
