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)

Status:  In Follow-Up

Recruited:  11 (40 across all sites)

Registration:  NCT04238676

Sponsor: Persica Pharmaceuticals Ltd

Collaborator: Micron Research Ltd

The MODIC Trial is an international, double blind, randomised clinical trial comparing an an investigational drug known as PP353 with a placebo to see if it can ease chronic lower back pain where other treatments have failed to make a difference. PP353, developed by Kent-based Persica Pharmaceuticals, contains an antibiotic which can be injected directly into an intervertebral disc that shows signs of possible low-grade infection.

The first phase of this trial found PP353 to be safe and well tolerated in three patients. The second phase, involving 40 randomised patients, will determine if PP353 decreases pain levels and improves quality of life.

The scientific evidence supporting the trial includes (i) Cutibacterium acnes (which normally causes acne) being found in damaged discs, (ii) antibiotics given orally over a long period of time reducing pain in some patients, and (iii) changes to the structure of the vertebrae observed in 20-60% of patients with chronic low back pain (called Modic changes) being replicated when bacteria from patients are injected into rodent intervertebral discs.

The MODIC Trial is seeking patients with Modic changes who have had chronic low back pain for more than 6 months and who are willing to participate in this trial. It involves two intervertebral injections of PP353 or placebo and follow-up visits over a period of 12 months.

Main Contact:  Michelle.Kumin@ndm.ox.ac.uk