Back pain has affected human beings throughout recorded history and is one of the world’s leading causes of disability. For a long time, the consensus among the global medical community was that the treatment for back pain was simply rest.
This changed in 1988 when a Danish rheumatologist, Professor Claus Manniche, published the results of a clinical trial in The Lancet¹ demonstrating the efficacy of exercise therapy in treating what by then had been categorised as chronic low back pain. This study led to a paradigm shift in the understanding of low back pain and active spine rehabilitation, and its principles still underpin the standard of care for chronic low back pain (CLBP) today.
Yet a significant issue remained. Professor Manniche and another back pain expert, Dr Hanne Albert – colleagues at The Spine Centre at the University of Southern Denmark, – discovered that a significant percentage of CLBP patients did not respond to exercise-based therapy. Dr Albert noticed that certain CLBP patients had pathological changes in the vertebrae of the spine – Modic changes – on their MRI scans. Further extensive research lead to a breakthrough hypothesis: that low-grade bacterial infection in the discs of the vertebrae was the cause of severe disabilities for this particular patient group.
Despite widespread scepticism from the global medical community, this hypothesis was vindicated in a 2013 paper² published in the European Spine Journal. The paper described a double-blind, placebo-controlled, and randomised clinical trial with 162 patients which demonstrated that an oral antibiotic treatment offered a curative treatment for these CLBP patients by removing the cause of their pain – i.e., the bacterial infection. Dr Albert was awarded the prestigious German Award for Pain Research and Contribution to Medicine for this work and other studies in this space in 2017.
Persica Pharmaceuticals was founded in 2013 by Mr Peter Hamlyn, and Dr Alan Jordan, Professor Claus Manniche, Dr Hanne Albert and Dr Eliot Forster. Its mission was to develop a shorter course of treatment than that which was used in the trial (a 100-day course) by finding a more effective delivery method to the site of infection and, crucially, a means of ensuring that the treatment did not exacerbate the growing issue of antibiotic resistance.
After six years of development in collaboration with a range of contract partners, drug developers and CROs, Persica has created an injectable antibiotic formulation with these properties and has commenced clinical trials in order to demonstrate its safety and efficacy. Specifically, Persica will be targeting patients with ‘Modic 1’ changes or mixed ‘Modic 1’ and ‘Modic 2’ changes to their spine, as can be visualised on an MRI scan – representing millions of patients.
- Clinical trial of intensive muscle training for chronic low back pain, C Manniche, L Bentzen, G Hesselso̸e, I Christensen, E Lundberg, The Lancet 1998, 332 (8626-8627), 1473-1476 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(88)90944-0/fulltext
- 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, HB Albert, JS Sorensen, BS Christensen, C Manniche, European Spine Journal 2013, 22 (4), 697-707