With PP353, Persica’s objective is to replace the 100-day high-dose oral antibiotics course to treat CLBP, which have been shown to be effective in the clinical trials conducted by Dr Hanne Albert¹, with an injectable antibiotic formulation that will achieve high local concentration and adequate duration of exposure in the spine to effect the sterilisation of the infected disc.
Local administration of antibiotic has the potential to elicit a faster response because an effective drug concentration in the infected tissue is immediately achieved. It also significantly reduces the amount of drug required, reducing the likelihood of systemic side effects, especially those associated with perturbation of the gut microbiome.
Intradiscal administration of therapeutics to treat CLBP is an established but mostly ineffective route². Persica believes that an effective treatment must address the underlying cause of disease – the infection. An effective antibacterial therapeutic should reduce the inflammatory stimuli in the intervertebral space and adjacent bone and allow repair over time, leading to a reduction in pain.
Creating an intradiscal antibiotic formulation
During the development of PP353, Persica tested several generic antibiotics in vitro and in vivo to find an antibiotic with the required properties: active against the bacteria identified in disc and herniated tissue samples, little to no resistance in clinical isolates, and the ability to be formulated to provide a depot to extend the duration of exposure.
To enable administration of the antibiotic, Persica developed a unique formulation which delivers the antibiotics to the site of infection and ensures that it remains within the infected area.
1. Albert HB, Joan S. Sorensen, 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) 22:697–707.
2. Stall JB et al. Injection therapy for subacute and chronic low back pain. An Updated Cochrane Review. Spine (2008)14;1 : 49-59.