Persica Pharmaceuticals Has Completed the First Stage of its Clinical Trial on Unique Injectable to Treat Chronic Lower Back Pain

Persica Pharmaceuticals Ltd recently announced it has successfully completed the first stage of a Phase Ib clinical trial to evaluate the safety, tolerability, and pharmacokinetics of PP353.

CLBP is the world’s leading cause of disability and an area of significant unmet need. Patients can experience CLBP for several reasons which require different treatment options. There is now substantial evidence that in patients with Modic 1, representing up to 20% of all CLBP populations, the underlying disease mechanism is localised chronic disc infection with anaerobic bacteria. Patients with CLBP associated with Modic 1 experience a debilitating, long lasting condition that significantly affects quality of life and for which current best practice treatments are largely ineffective.

Several independent randomized controlled clinical trials have shown that high-dose, broad-spectrum oral antibiotics over a period of 90-100 days are highly 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, and its widespread use is precluded by the anticipated antibiotic resistance its adoption would bring.

PP353 is a sustained release formulation of an antibiotic to treat the chronic disc infection, which is designed for intradiscal injection under image guidance. PP353 offers a more effective delivery method, provides substantial antibiotic exposure at the affected site whilst minimizing systemic exposure, thereby reducing the likelihood of significant side effects and antibiotic resistance.

The Persica Phase 1b study was conducted in the UK at National Institute for Health Research (NIHR) funded facilities; the NIHR Lancashire Clinical Research Facility at the Royal Preston Hospital and at the NIHR Coventry and Warwickshire Clinical Research Facility at the University Hospitals Coventry and Warwickshire.

Three subjects received 3 mL intradiscal injections of PP353. The results were reviewed by the study Safety Review Committee which concluded that that PP353 was safe, well tolerated, the pharmacology was consistent and demonstrated prolonged exposure. The Committee recommended that efficacy of a two-dose regimen of PP353 be tested in the next stage of clinical evaluation.

Efficacy of PP353 will now be evaluated in a placebo-controlled randomised clinical trial assessing patient reported low back pain and disability in the UK, mainland Europe and New Zealand.

Steve Ruston, Chief Executive Officer of Persica Pharmaceuticals Ltd, said “Our mission is to deliver a new treatment for patients with for whom current therapies are largely ineffective. We believe PP353 has the potential to deliver benefit to millions of patients suffering from CLBP. After extensive preparation, we are excited to have entered the clinic, successfully completing the first stage and look forward to our further progress.”

Professor Chris Imray, Director of Coventry NIHR Clinical Research Facility at University Hospital, added “This is the latest step in our ongoing quest to offer early phase research opportunities to our patients. Complex studies like this can only be delivered through a real team effort and we have to thank everyone who is making this research study happen here.”

Peter Hamlyn, Consultant Spinal Neurosurgeon, Co-Founder of Persica, also added “After a lifetime searching for a treatment that would definitively relieve my patients’ suffering, the scientific team at Persica have delivered a World first in a therapy, relevant to a huge number of these patients, that genuinely offers to cure the underlying cause of their problem.”

CLBP is the leading cause of years lived with disability worldwide. There is a huge unmet medical need as current treatments are typically ineffective for this patient group – best practice conservative therapy has a marginal and temporary impact, current injection-based treatments do not reduce the number of surgical procedures including fusion and spinal reconstruction which are majorly invasive, expensive and relatively ineffective. However, for the US alone the direct and indirect costs exceed $100 billion a year with the last three decades seeing their spending on injections increase by 600% and surgery rates rise tenfold. Current treatments fail because they do not address the underlying causes of pain.

Patients that may be suitable for PP353 treatment can be readily identified on routine magnetic resonance imaging (MRI). In the USA and the five major European countries there are over 12 million Modic 1 CLBP patients already in care, with new cases emerging at a rate of around 1.5-2 million patients a year. With antibiotic therapy being several times more effective than current best practice this represents a substantial market opportunity.

PP353 is a sustained-release formulation of an antibiotic, which is designed for intradiscal injection under image guidance. PP353 provides substantial antibiotic exposure at the site of administration and minimizes 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, so market penetration of PP353 is likely to be rapid.

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). The Company was founded by Mr Peter Hamlyn, Dr Alan Jordan, Professor Claus Manniche, Dr Hanne Albert and Dr Eliot Forster, Mr Christopher Welch in 2013. Persica is headquartered in Kent, UK. For more information, visit www.persicapharmaceuticals.com.