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Chronic Low Back Pain Phase I (FIH) Clinical Trial at NHS sites

 

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Thursday, 23 September 2021

Chronic Low Back Pain Phase I (FIH) Clinical Trial at NHS sites

For networks this week we are sharing information about a clinical trial at NHS sites, the first part of the trial has just been completed – at two NHS sites during the pandemic.

Persica 002 is a first in human clinical trial testing intradiscal antibiotic injections for patients with chronic low back pain (CLBP). It is sponsored by Persica Pharmaceuticals.

Recruiting NHS sites (see below) would welcome referrals.

CLBP is the leading global cause of disability and a major health economic issue for all developed countries. Many of the existing treatment options for CLBP are ineffective and the use of strong analgesic medication is common.

It is thought that disc herniations and subsequent infiltration of bacteria may initiate a series of events that in turn lead to bacteriologically-induced inflammation, degeneration and oedema. Vertebral body endplate oedema (Modic 1) can be visualised by MRI imaging.

In patients with CLBP associated with Modic 1 changes, the effects of treatment with oral antibiotics (amoxicillin-clavulanic acid) have been reported in 4 clinical trials. All these studies have demonstrated significant benefit of treatment with antibiotics (amoxicillin-clavulanic acid or amoxicillin) for 90 or 100 days. In a randomised controlled trial (n=162), there was a statistically significant improvement in the treated group compared with placebo on primary and secondary outcome measures at 1-year follow-up. The 12-month MRI scans also demonstrated a decrease in volume of the Modic 1 oedema compared with placebo.

However, the use of high dose oral antibiotics for 90–100 days is challenging as they are not well tolerated. Persica Pharmaceuticals has specifically formulated PP353 to allow the delivery of antibiotic linezolid as a depot to the intervertebral disc and intervertebral space.

The primary goal of this clinical trial is to demonstrate safety and tolerability of PP353 in otherwise healthy subjects with CLBP and to evaluate the efficacy of PP353 to reduce CLBP. Other measures, such as reduction in disability due to CLBP, reduction in analgesic use and reduction in vertebral endplate oedema changes on MRI, will also be assessed.

The key inclusion criteria are:

• Moderate to severe CLBP in the area L1 to S1 associated with vertebral body endplate oedema (Modic 1) or vertebral body endplate oedema and fat (Modic 1 and 2) at a single lumbar level. Modic 2 alone (at levels other than target Modic 1 level) is allowed if not contributing to the back pain.
• Current episode of CLBP has lasted for > 6 months.

Further information can be found on the link https://clinicaltrials.gov/ct2/show/NCT04238676

Recruiting NHS Sites:
• Royal Preston Hospital Lancashire Teaching Hospitals NHS Trust Clinical Research Facility - contact Shiva Tripathi at email .