Brixton Biosciences Presents Pivotal NICE Clinical Trial Data Showing Reneurx™ Nerve-Selective Therapy is Superior to Corticosteroid Injection for Pain Associated with Knee Osteoarthritis
82.2% of patients treated with Reneurx therapy achieved at least 30% pain reduction at three months versus 63.8% with intraarticular corticosteroids; benefit maintained through six months
Patients treated with Reneurx therapy reported meaningful improvements in knee function and quality of life, including those with higher body mass index and severe knee osteoarthritis
Marketing authorization pending for commercial use of Reneurx therapy for pain associated with knee osteoarthritis; U.S. FDA decision expected by year-end
CAMBRIDGE, MA, November 9, 2026 – Brixton Biosciences (Brixton), a clinical-stage life sciences company focused on developing a nerve-selective biomaterial designed to provide targeted and durable relief from pain, today announced results from the pivotal NICE clinical trial, which demonstrated that Reneurx™ Nerve-Selective Therapy was superior to intraarticular corticosteroid (IACS) injection for reducing pain in adults with symptomatic knee osteoarthritis. The data were presented by Yogesh Mittal, MD, a board-certified orthopedic surgeon and a NICE clinical trial investigator, during a podium presentation at the 2026 American Association of Hip and Knee Surgeons (AAHKS) Annual Meeting.
Data from the trial demonstrated that the study met its primary endpoint, with 82.2% of patients treated with Reneurx therapy achieving at least a 30% reduction in knee pain at 12 weeks, compared with 63.8% of patients who received an IACS injection. The benefit was maintained for six months, when 85.1% of Reneurx therapy patients were responders versus 61.3% in the IACS group.
“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.”
“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.”
Pivotal Data Highlights
The NICE clinical trial was a U.S. multicenter pivotal, randomized, controlled study designed to evaluate the safety and effectiveness of Reneurx therapy for pain management associated with knee osteoarthritis. The trial enrolled 264 patients randomized 2:1 to receive Reneurx therapy or a single IACS injection, with follow-up through six months.
- 2% of patients treated with Reneurx therapy achieved at least a 30% reduction in knee pain at three months, compared with 63.8% of patients who received a IACS injection.
- 1% of Reneurx therapy treated patients were responders at six months, versus 61.3% in the IACS group.
- At six months, 53.9% of Reneurx therapy patients achieved at least 80% pain reduction, versus 26.3% observed with IACS.
- Reductions in Numerical Rating Scale (NRS) pain scores were significantly greater with Reneurx therapy at every assessment from week 8 through end of study at week 24 (p<0.0001 at week 24).
- In patients with a body mass index of 30 or higher, mean NRS pain scores fell from 6.8 at baseline to 2.4 at week 24 with Reneurx therapy, versus 6.9 to 4.5 with corticosteroids (p<0.0001). In patients with severe (Kellgren-Lawrence grade 4) osteoarthritis, scores fell from 7.0 to 2.6 with Reneurx therapy, versus 7.0 to 4.3 with corticosteroids (p<0.005).
- Patients treated with Reneurx therapy reported significantly greater improvement on the Knee injury and Osteoarthritis Outcome Score for Joint Replacement, rising from 42.5 at screening to 69.5 at week 24, versus 41.8 to 60.6 with corticosteroids (p<0.005).
- 98% of device-related adverse events (AEs) were mild or moderate in severity. The most frequent device-related AE was erythema (skin redness) that was mostly mild (73.6%) or moderate (26.4%), with no severe events, and resolved without intervention. Serious AE rates from all causes were not significantly different between groups (5.6% with Reneurx therapy versus 3.5% with IACS).
A marketing application for the commercial use of Reneurx therapy for pain associated with knee osteoarthritis is currently under review by the U.S. Food and Drug Administration, with a decision expected by year-end.
About Brixton Biosciences
Brixton Biosciences is a life sciences company developing a novel, first-in-class nerve-selective biomaterial designed to provide targeted and durable relief from pain. The Company’s flagship product, Reneurx™ Nerve-Selective Therapy, is injected around a target treatment area to interrupt pain signals. In its first indication for patients with knee osteoarthritis, clinical data demonstrates that patients with symptomatic knee osteoarthritis experience 6 months of meaningful pain relief. Brixton’s pipeline includes additional programs for lateral hip and thumb joint pain, migraine, and potential applications in many other areas. For more information, visit www.brixtonbio.com.
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