Persica Reports Positive Phase 1b Results for Novel Antibiotic Treatment in Chronic Low Back Pain
Here is a summary of the key information about Persica Pharmaceuticals' early-stage clinical trial results for their antibiotic-based therapy PP353 for chronic low back pain:
PP353 is an antibiotic-based intradiscal injection developed by Persica Pharmaceuticals to treat chronic low back pain associated with Modic Type 1 changes
The Phase 1b trial met its primary endpoint, showing statistically significant and clinically meaningful reductions in pain and disability compared to placebo
Key results:
3.4-point (50%) within-group reduction in pain from baseline at 12 months
1.4-point (30%) between-group reduction in pain vs placebo at 12 months
Clinically meaningful pain reductions starting at 3 months and continuing to improve at 12 months
Statistically significant reductions in disability measures
PP353 was well-tolerated with no limiting gastrointestinal side effects observed
The therapy targets a subgroup of chronic low back pain patients (~25%) who have evidence of disc infection visible as Modic Type 1 changes on MRI
Persica is preparing for discussions with regulators about advancing to registrational trials
Experts quoted in the release called the results promising and potentially meaningful for back pain patients if confirmed in larger studies