Persica 002 Phase 1b PP353 vs Placebo in the Treatment of Low Back Pain

Inclusion Criteria

• Aged between 18 and 70 years, inclusive.
• Chronic low back pain in the area associated with vertebral body endplate bone oedema (Modic 1) or vertebral body endplate bone oedema and fat (Modic 1 and 2) at a single lumbar level.
• Average LBP NRS score at screening and at Day 1 pre-randomisation ≥ 4 on chronic pain medication and ≥ 6 if not on chronic pain medication; it should be higher than the leg pain NRS score
• RMDQ-23 score ≥ 9 at screening and at Day 1 pre-randomisation.
• Current episode of chronic low back pain has lasted for ≥ 6 months at the time of randomisation.
• Bodyweight of ≥ 50 kg and ≤ 120 kg.
• Failure of standard of care therapies used by their treating physician

Exclusion Criteria

• Any vertebra with Modic 2 only lesions which:
• in the opinion of the investigator, after deep palpation of the vertebral spine, is contributing to the low back pain and/or
• are present within 2 vertebrae from the target lumbar disc.
• The target lumbar disc has lost more than half its original anticipated height at the centre or it is < 5mm in height over the central 15 mm portion
• A clear alternative cause for back pain
• Gross facet joint degeneration or cases where the investigator believes the primary pain generator to be the facet joints
• Interventional back procedure in the 6 months prior to screening or major surgery in the 12 weeks prior to screening
• History of alcohol abuse or drugs of abuse in the past 2 years
• Any other significant illness
• Previously been treated with antimicrobial agents for their low back pain or previously received any antimicrobial intradiscal injection.