Persica Pharmaceuticals’ research published in Journal of Orthopaedic Research Spine ahead of anticipated clinical data in 2025

• Persica is developing PP353, a potentially curative, opioid-sparing treatment for patients with chronic Low Back Pain
• Persica’s work builds on substantial evidence that chronic Low Back Pain with Modic changes can be caused by a bacterial infection of the vertebral disc
• PP353 is a novel, patented antibiotic preparation for intradiscal injection to treat the infection and provide long-term pain relief
• Two papers published in Journal of Orthopaedic Research Spine show the promise of PP353 through preclinical development and the First-in-Human data, laying the groundwork for safety and efficacy results from The Modic Trial, expected in Q1 2025

London, UK, 19 November 2024 - Persica Pharmaceuticals Limited (Persica), a clinical stage pharmaceutical company developing an antibiotic formulation for intradiscal injection to treat chronic Low Back Pain (cLBP), today announces 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 today 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.

Ends

For further information:ICR Healthcare:Tracy Cheung, Chris Welsh, Emily Johnsonpersica@icrhealthcare.com  

The papers published in JOR Spine

1. 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 
2. 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

About Persica Pharmaceuticals         Persica Pharmaceuticals is a clinical stage pharmaceutical company developing PP353, a novel, patented intradiscal antibiotic injection to treat chronic Low Back Pain with vertebral body endplate bone oedema (Modic 1). The Company was founded by Mr Peter Hamlyn, Dr Alan Jordan, Professor Claus Manniche, Professor Hanne Albert, Dr Eliot Forster and Christopher Welch in 2013. www.persicapharmaceuticals.com

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.