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

A Phase 1b Study Investigating the Safety, Tolerability and Efficacy of PP353 in the Treatment of Patients With Chronic Low Back Pain Associated With Vertebral Body Endplate Bone Oedema (Modic 1)

A Phase 1b study to investigate the efficacy of PP353 compared to placebo in the treatment of chronic low back pain associated with bone oedema.

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.

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:

  1. in the opinion of the investigator, after deep palpation of the vertebral spine, is contributing to the low back pain and/or
  2. 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.