CAMBRIDGE, Mass.–Brixton Biosciences has reported positive results from a pivotal clinical trial showing that its investigational Reneurx Nerve-Selective Therapy provided greater and longer-lasting pain relief than corticosteroid injections in patients with symptomatic knee osteoarthritis.
The findings from the NICE clinical trial showed that 82.2% of patients receiving Reneurx therapy experienced at least a 30% reduction in knee pain after three months, compared with 63.8% of patients treated with intraarticular corticosteroid injections.
The treatment benefit continued through six months, when 85.1% of Reneurx patients maintained the same level of pain reduction, compared with 61.3% in the corticosteroid group.
The results were presented by Yogesh Mittal, MD, a board-certified orthopedic surgeon and NICE trial investigator, at the 2026 American Association of Hip and Knee Surgeons Annual Meeting.
Brixton, a clinical-stage life sciences company developing nerve-selective biomaterials for pain management, said the study met its primary endpoint and demonstrated statistically significant improvements in pain reduction, knee function and quality of life.
The NICE trial was a multicenter, randomized, controlled study conducted in the United States involving 264 adults with symptomatic knee osteoarthritis. Participants were randomly assigned in a 2:1 ratio to receive either Reneurx therapy or a single intraarticular corticosteroid injection, with follow-up assessments conducted over six months.
At six months, 53.9% of patients treated with Reneurx achieved at least an 80% reduction in pain, compared with 26.3% of those receiving corticosteroid injections.
Patients receiving Reneurx also experienced significantly greater reductions in pain scores at every assessment beginning at week eight through the end of the study at week 24.
“These NICE results provide head-to-head evidence that Reneurx therapy can deliver deeper, longer-lasting relief to patients with pain associated with knee osteoarthritis than corticosteroid injection – the current routine treatment for knee pain,” said Sameer Sabir, Chief Executive Officer of Brixton Biosciences. “Reneurx therapy outperformed corticosteroid injection at every pain-reduction threshold measured, at both three and six months, with the gap widening over time as corticosteroid response declined. These efficacy and durability data are particularly encouraging and further validate our nerve-selective approach to pain relief while strengthening our confidence in the broader potential of Reneurx therapy to address other sources of chronic joint pain.”
The study also found that Reneurx provided benefits among patients with obesity and those with advanced osteoarthritis, two populations that can be particularly challenging to treat.
Among patients with a body mass index of 30 or higher, average pain scores on the Numerical Rating Scale declined from 6.8 at baseline to 2.4 after 24 weeks with Reneurx therapy. Patients receiving corticosteroid injections experienced a smaller reduction, from 6.9 to 4.5.
For patients with severe knee osteoarthritis, classified as Kellgren-Lawrence grade 4, average pain scores decreased from 7.0 to 2.6 with Reneurx, compared with a decline from 7.0 to 4.3 in the corticosteroid group.
Both comparisons were statistically significant.
“Patients with pain from knee osteoarthritis have limited options for lasting pain relief, and the benefit of corticosteroid injections often diminishes with repeated use while raising concerns about long-term joint health,” said Dr. Yogesh Mittal. “Durability is what matters most in managing these patients, and a single treatment that sustains relief through six months has the potential to change how we approach non-operative care. Of particular clinical relevance, the benefit extended to patients with elevated body mass index and advanced disease, who are among the most challenging to treat.”
Beyond pain reduction, the trial demonstrated improvements in knee function and patient-reported outcomes.
Patients treated with Reneurx experienced an increase in their Knee injury and Osteoarthritis Outcome Score for Joint Replacement from 42.5 at screening to 69.5 at week 24. In comparison, scores among corticosteroid-treated patients increased from 41.8 to 60.6.
The difference between the treatment groups was statistically significant, suggesting greater improvements in knee-related function among patients receiving Reneurx.
The company also reported favorable safety findings. Approximately 98% of device-related adverse events were classified as mild or moderate.
The most frequently reported device-related adverse event was erythema, or skin redness, which resolved without medical intervention. No severe cases of device-related erythema were reported.
Serious adverse events from all causes occurred in 5.6% of Reneurx-treated patients and 3.5% of corticosteroid-treated patients, a difference that was not statistically significant.
Knee osteoarthritis is a degenerative joint condition that causes pain, stiffness and reduced mobility. Corticosteroid injections are commonly used to manage symptoms, although their effectiveness may diminish over time.
Brixton is developing Reneurx as a nerve-selective treatment intended to provide sustained pain relief without relying on conventional corticosteroid injections.
The company has submitted a marketing application to the U.S. Food and Drug Administration seeking authorization to commercialize Reneurx therapy for pain associated with knee osteoarthritis.
An FDA decision is expected by the end of 2026.
If authorized, Reneurx could offer an additional nonsurgical treatment option for patients managing chronic knee osteoarthritis pain. However, the therapy remains investigational until regulatory approval is granted.
