Persica is developing PP353, a targeted, non-opioid treatment for vertebrogenic Lumbar Back Pain (vLBP), chronic Low Back Pain associated with Modic type changes. Modic changes are a sign of inflammation, visible on MRI scans at the vertebral endplate adjacent to a degenerate lumbar disc. These changes have been shown to be present in approximately 6% of the general public and 15% of the cLBP population [1]. These patients experience a debilitating, long lasting condition that significantly affects their quality of life and for which existing treatments including exercise, physiotherapy and even invasive procedures are largely ineffective.

The treatment, based on the groundbreaking clinical research led by Albert and Manniche which demonstrated the link between cLBP and  low-grade bacterial infection in the discs of the spine[2], is a minimally invasive injection of antibiotic formulation directly to the site of infection. The direct delivery method, low dose and short course of treatment offers means of minimising side-effects of prolonged oral antibiotic therapy and ensures that the treatment does not exacerbate the growing problem of antibiotic resistance.

CLINICAL TRIALS

Study Identification

Unique Protocol ID: Persica 002

Brief Title: Persica 002 Phase 1B PP353 vs Placebo in the Treatment of Low Back Pain

Official Title: A Phase 1b Study Investigating the Safety, Tolerability and Efficacy of PP353

in the Treatment of Patients with Chronic Low Back Pain Associated With

Verterbral Body Endplate Bone Oedema (Modic 1)

Secondary IDs: 2018-004488-30 [EudraCT Number]

Description: A 2-part study. In the first part the safety, tolerability and pharmacokinetics will

be assessed in up to 6 participants. In the second part, the safety, tolerability

and efficacy of PP353 will be assessed in up to 40 participants.

Further information: Clinical Trials Registry
For healthcare professionals: themodictrial.com