Chronic Low Back Pain – Clinical trials

Persica has developed a new therapy to treat patients suffering from CLBP due to low-grade bacterial infection in the discs of the spine. These patients are experiencing 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.

Specifically, Persica’s novel antibiotic treatment is targeted at CLBP patients that have easily identifiable changes to their spine as seen on MRI scans, termed Modic 1 and mixed Modic 1-2 changes/bone oedema (swelling). These changes have been shown to be present in approximately 6% of the general public and 30% of the CLBP population[5].

The treatment, based on the groundbreaking clinical research led by Albert and Manniche which demonstrated the link between CLBP and bacterial infection, 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.

CLBP is the world’s leading cause of disability and the associated costs to society, including treatment, time off work and disability pensions, are estimated to be £12-15 billion per annum in the UK and more than $80 billion per annum in the USA. Similar findings have been reported in most advanced countries[1],[2],[3].

 

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 34 participants.

[1]Maniadakisa N, Grayb, A. The Economic Burden of Back Pain in the UK – PAIN 84 (2000), 95-103. https://www.sciencedirect.com/science/article/pii/S0304395999001876

[2] RA, Cherkin D, Conrad D, Volinn E. Cost, controversy, crisis: low back pain and the health of the public. Annu Rev Public Health 1991, 12:141-156. https://www.annualreviews.org/doi/10.1146/annurev.pu.12.050191.001041

[3] Degenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine 2008, 8(1):8-20. https://www.ncbi.nlm.nih.gov/pubmed/18164449

[4}Grazier KL, Holbrook TL, Kelsey JL, et al. The frequency of occurrence impact and cost of musculoskeletal conditions in the United States, Chicago, IL: American Academy of Orthopedic Surgeons, 1984. https://link.springer.com/article/10.1007/BF00433381

[5]Albert HB, Sorensen JS, Schiott Christensen B, Manniche C. Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy. Eur Spine J, 2013. https://www.ncbi.nlm.nih.gov/pubmed/23404353

[6]Jensen TS, Karppinen J, Sorensen JS, Niinima¨ki J, Leboeuf-Yde C (2008) Prevalence of vertebral endplate signal (Modic) changes and their association with non-specific low back pain—A systematic literature review. Eur Spine J 17,1407–1422. https://www.ncbi.nlm.nih.gov/pubmed/18787845