Chronic lower back pain is one of the top complaints that sends Americans to their doctors — and it’s a leading cause of missed workdays and disability claims.
While slipped discs, arthritis and spinal problems are often blamed, for some, the real culprit is an infection. Now, there’s hope on the horizon for these patients.
Early clinical trial results indicate a new antibiotic drug could treat — or even cure — the infection. Experts are hailing it as a “massive gamechanger” with the potential to drastically improve the quality of life for those suffering from chronic lower back pain.
Research suggests that for about 25% of patients with chronic back pain, the cause is a bacterial infection in their spinal discs — the spongy tissue that cushions and absorbs shock between vertebrae.
This infection damages nearby bones, irritates nerves and fuels inflammation, leading to ongoing back pain. It also triggers changes in the bone marrow, known as Modic changes, which can be detected through an MRI scan.
UK-based biotech company Persica Pharmaceuticals has developed a drug that uses antibiotics to target and eliminate the infection, aiming to address the root cause of the pain rather than just masking the symptoms.
The treatment, called PP353, combines three widely used substances: linezolid, an antibiotic; iohexol, a contrast agent; and a thermosensitive gel that helps deliver the drug directly to the site of infection.
To test its effectiveness, Persica enrolled 44 patients from the UK, Spain, Denmark and New Zealand. All participants had suffered from severe back pain for at least six months — some for more than five years — and had Modic changes. Their conditions had not improved with standard non-surgical treatments, such as physical therapy or painkillers.
Each patient received two injections of PP353 four days apart in their lower back. The results were promising: six in 10 participants reported “significant” improvements, including reduced pain and disability.
Remarkably, patients continued to show improvement even 12 months after the treatment. Additionally, PP353 was well-tolerated, with no serious gastrointestinal side effects.
Dr. Joshua A. Hirsch, an interventional neuroradiologist at Massachusetts General Hospital and US medical adviser for Persica, praised the promising early results of the drug.
“In this early study, the treatment arm did significantly better than placebo in essentially all parameters that were studied. Perhaps even more exciting, the impact appears to get better over time,” he said.
“If borne out in larger studies, the implications for back pain patients are potentially very meaningful,” Hirsch added.
Plus, since PP353 isn’t an opioid, it could offer an alternative for patients with chronic lower back pain looking to avoid addictive painkillers amid the ongoing opioid crisis in the US.
However, it will likely be some time — if at all — before the drug is in the hands of patients.
The randomized clinical trial had a small sample size, so further testing is needed, and the drug must be approved by federal regulators before it can hit the market.
Persica is currently working on launching a larger trial.
Still, experts say the early results are promising and suggest the treatment could one day have a profound impact on patients’ lives and society at large.
“If we can get these 25% of the patients with chronic low back pain back to work, back to no medications, back to no more disability, then I think [that] will be the massive gamechanger for the future,” Dr. Shiva Tripathi, a pain consultant at the National Health Service and the chief investigator of the trial, told The Guardian.
