SEL-212 demonstrated efficacy in gout refractory to standard treatment

SEL-212, a novel, once-monthly therapy, has shown clinical efficacy and safety in patients with gout that is refractory to standard treatment, according to the latest data presented at the 2024 European Congress of Rheumatology (EULAR).

What is SEL-212 and how does it work?

SEL-212 consists of immune-tolerizing nanoparticles that contain sirolimus (SEL-110), given in either high dose (HD, 0.15 mg/kg) or low dose (LD, 0.1 mg/kg) formulations, followed by a dose of pegylated uricase (SEL-037) for six treatment periods (TP).

The therapy is designed to reverse the outcomes of sustained hyperuricemia including painful flares, chronic gouty arthropathy, and tophi, which increase the risk of refractory gout in patients who have failed to normalize serum uric acid (sUA) despite receiving medically appropriate doses of an oral uric acid lowering therapy.

SEl-212 Shows Positive Results for Refractory Gout

The primary endpoint in the trial was response rate, defined as sUA levels < 6 mg/dL for ≥ 80% of the time during TP6. The stopping rule was defined as sUA < 2.0 mg/dL (1-hour post-treatment in TP1) and sUA > 1.0 mg/dL (Day 21, TP1), or sUA > 6.0 mg/dL (Day 21, TP2, 3, 4, or 5).

Results indicated that 51% of patients in the HD group and 43% of patients in the LD group met the primary endpoint, compared to only 8% of patients receiving a placebo, demonstrating a significant improvement in response rate for the treatment groups compared to the control group.

Furthermore, 41% of patients in the HD group and 43% of patients in the LD group who had tophi at baseline achieved a risk ratio that was significantly higher than placebo (9%; P = . 0003 and . 0002, respectively).

Safety and Efficacy of SEL-212

The clinical trials of SEL-212 demonstrated that the novel therapy was safe and tolerable among the cohort of patients with gout that is refractory to standard treatment. Most patients reported at least one treatment-emergent adverse event (TEAE); however, most were mild or moderate in severity and did not lead to any withdrawals.

The most common TEAE was gout flare reported in 42.5% (n = 37) in the HD group, 44.3% (n = 39) in the LD group, and 43.3% (n = 39) in the placebo arm. The infusion-related adverse events were reported in 4.5% (n = 4) in the LD group, 3.4% (n = 3) in the HD group and 0% in the placebo group.

Conclusion

The results of the clinical trials of SEL-212 suggest that it could be a well-tolerated and effective uricase-based urate-lowering therapy in patients with refractory gout. The therapy’s ability to reverse the outcomes of sustained hyperuricemia, which increase the risk of painful flares, chronic gouty arthropathy, and tophi, demonstrates its potential in the therapeutic area of gout and its related conditions.

Originally Post From https://www.hcplive.com/view/sel-212-demonstrates-clinical-safety-efficacy-in-gout

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