Persica Pharmaceuticals completes recruitment into Modic Trial assessing efficacy of PP353, to treat chronic lower back pain
London, UK, 07 March 2024 – Persica Pharmaceuticals Ltd, a privately held, clinical stage pharmaceutical company developing an antibiotic formulation for intradiscal injection to treat Chronic Low Back Pain (CLBP) and disability associated with bone oedema (Modic 1), which is caused by bacterial infection, today announces the completion of enrolment of participants into its Phase 1b Modic Trial. The trial is being conducted in the UK, Denmark, New Zealand and Spain.
CLBP is a leading cause of disability with significant unmet medical need and contributes to the overuse of chronic opioid therapy. Patients can experience CLBP for several reasons. There is now substantial evidence that in CLBP patients with Modic 1, the underlying disease mechanism is a localised chronic low grade bacterial infection of the disc. Conventional interventions such as analgesia, physiotherapy or psychotherapy are largely ineffective for this patient population.
Independent randomised controlled clinical trials have shown that high-dose, broad-spectrum oral antibiotics over a period of 3 months are effective in the treatment of CLBP associated with Modic 1, representing clinical proof of concept and efficacy for the use of antibiotics in this patient group. However, such prolonged oral antibiotic therapy is poorly tolerated, requires diligent compliance and its widespread use is precluded by the anticipated antibiotic resistance its adoption would bring.
PP353 is an antibiotic formulation designed for intradiscal injection under image guidance to provide substantial antibiotic exposure at the infected site while minimising systemic exposure, thereby reducing the likelihood of significant side effects and antibiotic resistance.
The Modic Trial is a placebo-controlled randomised clinical trial assessing the safety and efficacy of PP353 as a treatment for patients with CLBP associated with Modic 1 changes. All 40 subjects have been enrolled and randomised 1:1 to placebo sham treatment or PP353 with no safety issues reported. The trial primary outcome measures include safety and patient-reported low back pain over 12-months. Other outcome measures include patient reported low back pain, disability, volume of vertebral bone oedema and pharmacokinetics at intermediate time points and at 12-months.
Details of the Modic Trial can be found at clinicaltrials.gov using identifier NCT04238676.
Dr Steve Ruston, Chief Executive Officer of Persica Pharmaceuticals Ltd, said: “CLBP is a debilitating condition which affects millions of people. Our mission is to provide a new and effective option for patients who are underserved by current therapies, and we believe that PP353 has enormous potential to make a positive impact on many peoples’ lives. We look forward to reviewing the data from this important study.”
Prof Shiva Tripathi MBBS MD FRCA, Chief Investigator at Lancashire Teaching Hospitals NHS Foundation Trust said: “We have been excited to participate in this study to examine Persica’s unique approach to addressing a significant unmet need among Modic 1 CLBP patients. If validated, this new approach has enormous potential to improve the lives of a substantial segment of patients with a debilitating condition.”
For further information:
Persica Pharmaceuticals
Dr Steve Ruston (Chief Executive Officer)
info@persicapharmaceuticals.com
ICR Consilium
Chris Welsh, Dylan Wilks
persica@consilium-comms.com
About Chronic Low Back Pain associated with vertebral body endplate bone oedema (Modic 1)
Current treatments may fail because they do not address the underlying causes of pain, a bacterial infection in the disc. Patients that may be suitable for PP353 treatment can be readily identified on routine magnetic resonance imaging (MRI). In the USA, CLBP with Modic changes is recognised with diagnostic procedure code ICD-CM-54.51. In the USA, 500,000 patients are currently diagnosed with CLBP and Modic 1 per year. With the advent of an effective new therapy diagnosis rates may multiply.
About PP353
PP353 is a formulation of an antibiotic which is designed for intradiscal injection under image guidance. PP353 provides substantial antibiotic exposure at the site of administration and minimises systemic exposure, reducing the likelihood of significant side effects and antibiotic resistance. Spinal injections are typically performed as out-patient procedures and are a routine part of current spinal care.
About Persica Pharmaceuticals
Persica Pharmaceuticals is a clinical stage pharmaceutical company developing PP353, a unique intradiscal antibiotic formulation to treat Chronic Lower Back Pain with vertebral body endplate bone oedema (Modic 1).
Persica is headquartered in Kent, UK. For more information visit www.persicapharmaceuticals.com.
