Persica is looking ahead to registrational trials after its antibiotic therapy met the primary endpoint in a Phase Ib trial. Image credit: Shutterstock / New Africa.
Persica Pharmaceuticals will advance its antibiotic-based drug to registrational studies after a Phase Ib study found that the therapy alleviated lower back pain in patients.
The UK-based biotech said that the trial (NCT04238676) of PP353, a novel, non-opioid intradiscal injection, met its primary endpoint, demonstrating a statistically and clinically meaningful and durable reduction in pain in 44 patients with chronic low back pain with Modic type 1 changes.
Evidence has shown that a sub-group of patients, approximately 25%, with chronic lower back pain have an indolent infection in the disc space, which is what leads to Modic changes. The antibiotic-based therapy is a combination of linezolid, iohexol and a thermosensitive gel. It is injected into the degenerate lumbar disc to provide prolonged exposure at a high concentration at the site of infection. This reduces pain by treating the infection and reducing inflammation.
In the trial, patients received two doses of PP353 four days apart. Patients reported a 3.4-point within-group reduction in pain from baseline and a 1.4-point (30%) between-group reduction from placebo at 12 months. Some patients reported benefit three months after dosing with the benefit continuing throughout the study. Pain was evaluated using the Low Back Pain Numerical Rating Scale (LBP NRS).
There were also statistically significant and clinically meaningful reductions in disability with a within-group decrease of 9.4 points and a between-group reduction of 3.9 points from placebo after 12 months. These benefits started as early as one month after dosing, with patients continuing to improve throughout the trial.
Persica said its antibiotic-based drug was well-tolerated in the trial and no limiting gastrointestinal adverse events (AEs) were observed.
As a result of the positive Phase Ib data, Persica is preparing for discussions with regulators to advance PP353 to registrational trials.
Persica CEO Dr Steve Ruston said: “The results of our Phase Ib trial bring us closer to our mission of delivering a new and effective treatment option for patients underserved by current therapies.
“The positive clinical effects of PP353 provide further compelling evidence of the role of infection in patients with chronic lower back pain and Modic 1 changes and could enable expedited clinical development. We are now advancing towards registrational studies.”
Race for non-opioid-based pain therapies
There are several companies globally looking for non-opioid-based pain therapies to address the opioid crisis in the US. Most deaths are caused by illicit fentanyl use, but the crisis was first incited by opioid overprescription and overmarketing. The opioid addiction market across the eight major markets (8MM: Australia, Canada, France, Germany, Italy, Spain, the UK, and the US) is set to grow from $2bn in 2023 to $2.4bn in 2033, according to a GlobalData report.
GlobalData is the parent company of Clinical Trials Arena.
Research, backed by the National Institute of Health (NIH) is underway to evaluate the capabilities of glucagon-like peptide-1 receptor agonists (GLP-1RAs) as a solution to the opioid crisis. Although it may seem an unusual mechanism of action to treat the epidemic, GLP-1RAs act on the brain’s reward system, an area deeply involved in addiction.
Earlier this week, Lexicon reported its non-option-based pain therapy outperformed placebo in a Phase II trial that enrolled patients with severe diabetic peripheral neuropathic pain.
Vertex is also looking to make its name in the pain relief space as it eyes approval for its non-opioid pain therapy VX-548, which met its primary endpoint in two Phase III trials. However, the company did take a hit when a Phase II trial of the drug. While it met the primary endpoint, it did not show a significant improvement over placebo.
Clinical trials in pain remain complex as it is highly individual and subjective, making it difficult to effectively evaluate endpoints.
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