Persica Pharmaceuticals announces positive Phase 1b clinical data for PP353, a novel, non-opioid intradiscal injection for the treatment of chronic Low Back Pain
- The PP353 clinical trial met the primary endpoint and demonstrated statistically significant, clinically meaningful and durable reduction in pain and disability in patients with chronic Low Back Pain with Modic Type 1 changes
- Meaningful reductions in pain from 3 months up to at least 12 months
- Approximately 25% of patients with moderate to severe chronic Low Back Pain have Modic Type 1 changes which equates to ~4 million in the major markets (US, EU, Japan)
- Persica is preparing for discussions with regulators about advancing to registrational trials
London, UK, 05 March 2025 - Persica Pharmaceuticals Limited (Persica), a clinical stage biotechnology company developing a transformative treatment for chronic Low Back Pain (cLBP), today announces positive topline data from its Phase 1b Modic Trial, a randomised, double-blind, placebo-controlled clinical trial assessing the safety and efficacy of PP353 as a treatment for patients with cLBP associated with Modic Type 1 changes. PP353 has the potential to offer patients an alternative to long-term opioid use for pain relief, by targeting the cause of the pain rather than the symptoms.
Over the last 10 years there has been growing evidence that a sub-group of patients with cLBP have a chronic indolent infection in the disc space, leading to Modic changes, which are a sign of inflammation which is visible at the vertebral endplate adjacent to a degenerate lumbar disc, and which can extend into the body of the vertebrae. PP353 is a specifically formulated combination of linezolid, iohexol and a thermosensitive gel that is injected into the degenerate lumbar disc, delivering prolonged exposure of a high concentration at the site of infection. The treatment, a 2-dose regime (dosed 4 days apart), can eliminate the infection, thus addressing the underlying cause of the pain.
Topline results from the Phase 1b trial:
- The PP353 clinical trial met the primary endpoint and demonstrated statistically significant and clinically meaningful results in patients with chronic Low Back Pain with Modic Type 1 changes, with a 3.4-point (50%) within-group reduction in pain from baseline and a 1.4-point (30%) between-group reduction from placebo at 12 months in the Full Analysis Set of subjects.
- The PP353 group reported clinically meaningful reductions in pain from baseline from 3 months onwards and were continuing to improve at 12 months. The placebo group did not achieve clinically meaningful change from baseline.
- The PP353 group also reported statistically significant and clinically meaningful reductions in disability with a within-group reduction of 9.4-points (63%) and a between-group reduction of 3.9-points (39%) from placebo in the Full Analysis Set of subjects at 12 months.
- The PP353 group reported clinically meaningful reductions in disability from baseline from 1 month onwards and were continuing to improve at 12 months. The placebo group did not achieve clinically meaningful change from baseline until 6 months.
- Greater outcomes were observed in the Per Protocol Set of subjects.
- PP353 was well-tolerated, and no limiting gastro-intestinal side-effects were observed.
- The Modic Trial enrolled 44 patients in 4 countries and followed patients for 12 months. Patients had had cLBP for more than 6 months (mean duration of 5.5 years) and had not been helped by existing non-surgical treatments.
- Persica is preparing for discussions with regulators about advancing to registrational trials.
Joshua A. Hirsch, MD, Vice Chair Procedural Services and Service Line Chief of NeuroInterventional Radiology, Chief, Interventional Spine Service, Massachusetts General Hospital, (Past president American Society of Spine Radiology), said: “Any time an interventional treatment for pain can do well against placebo/sham control, providers and their patients should pay careful attention. 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. If borne out in larger studies, the implications for back pain patients are potentially very meaningful.”
Chris Gilligan, MD, Chief Medical and Quality Officer, Robert Wood Johnson University Hospital, said: “The obvious statistical significance, along with their consistency across a wide range of outcome measures, sets these early results apart from those of our current treatment options for these chronic low back pain patients. This, combined with the effective absence of any material side effects, leaves us very hopeful of seeing it come through Phase 3 trials to the clinic.”
Dr Steve Ruston, Chief Executive Officer of Persica Pharmaceuticals Ltd, said: “The results of our Phase 1b 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 cLBP and Modic 1 changes and could enable expedited clinical development. We are now advancing towards registrational studies.”
Ends
For further information:
ICR Healthcare:
Tracy Cheung, Chris Welsh, Emily Johnson
persica@icrhealthcare.com
About Persica Pharmaceuticals
Persica Pharmaceuticals is a clinical-stage biotechnology company developing PP353, a groundbreaking and transformative treatment for chronic Low Back Pain (cLBP) with Modic type 1 changes. Modic changes are a sign of inflammation which is visible, with Magnetic Resonance Imaging (MRI) scans, at the vertebral endplate adjacent to a degenerate lumbar disc, and which can extend into the body of the vertebrae. PP353 is a patented, targeted intradiscal antibiotic injection that is delivered directly to the site of infection. It is a non-opioid treatment which addresses an underlying cause of cLBP, rather than just the symptoms, and reduces the need for repeated antibiotic doses.
About PP353
PP353 (intradiscal linezolid) is a suspension of linezolid powder in a thermosensitive vehicle which is liquid at room temperature but increases in viscosity when injected into the site of infection and warmed to body temperature. This increase in viscosity prevents PP353 from leaking out of the degenerate disc into adjacent tissues during injection. PP353 also contains a radio-opaque dye which allows the physician to use image guidance to make sure the gel is positioned correctly in the target disc on injection.
About chronic Low Back Pain with Modic Type 1 changes
Chronic Low Back Pain (>3 months) with Modic Type 1 changes is a common patient subgroup (~25% of cLBP). These patients are readily identifiable on MRI and typically suffer from moderate to severe persistent pain and disability with limited relief from the current standard of care e.g. physiotherapy and analgesia including opioids with a prevalence of >2 million patients in the US alone. Current treatment options provide only limited short term relief or involve invasive and non-reversable nerve ablation which does not treat the underlying cause of the pathology, a probable bacterial infection of the disc.
