Chronic Low Back Pain (cLBP) is a debilitating condition that significantly affects the quality of life of millions of people, most of whom are not helped by existing treatments. The lack of effective treatment options for patients often results in long-term reliance on analgesics, such as opioids, to manage pain.

Pioneering research by Persica’s co-founders discovered that cLBP with Modic changes associated with bacterial infection in vertebral discs can cause serious, long-lasting pain and disability. High-dose oral antibiotics can be effective – but prolonged oral antibiotic therapy comes with patient compliance challenges and can lead to antibiotic resistance.

Persica is developing a groundbreaking and transformative treatment for chronic Low Back Pain with Modic changes. PP353 is a non-opioid, one-off treatment which addresses an underlying cause of cLBP, rather than just the symptoms. Modic changes are associated with bacterial infection in vertebral discs. PP353 is a patented and targeted intradiscal antibiotic injection that goes directly to the site of infection.

The product has a sustained release formulation allowing a two-dose regime with limited systemic exposure that overcomes the significant side-effects associated with prolonged oral antibiotic therapy.

Preclinical and First-in-Human data was published in JOR Spine in November 2024. Phase 1b data is expected in Q1 2025. Success in this trial, which is powered for efficacy, could enable rapid progression to registrational clinical trials.