Novartis reported positive results from the first Phase III study to evaluate its IL-1β-targeting mAb, ACZ885 (canakinumab), in patients with the childhood autoinflammatory disease juvenile idiopathic arthritis (SJIA). Data from the four-week study in 84 patients showed that 83.7% of those treated using ACZ885 achieved at least a 30% improvement in symptoms, compared with 9.8% of patients receiving placebo. A third of ACZ885-treated individuals achieved a 100% improvement in symptoms.
A second Phase III study is evaluating ACZ885 treatment with respect to time to next flare, and the reduction or elimination of corticosteroid use. Results from this trial are expected by year end. Novartis says it aims to file for worldwide regulatory approval of ACZ885 for the SJIA indication during 2012. ACZ885 is already marketed under the brand name Ilaris® for the treatment of adults and children aged four and up with Cryopyrin-Associated Periodic Syndromes, and is separately being evaluated for the treatment of inflammatory diseases including gouty arthritis and cardiovascular disease.
Regulatory filings for ACZ885 as a treatment for gouty arthritis have been filed in the EU and U.S. Last month the firm received a complete response letter from FDA stating that while it was happy with the overall efficacy of the drug, it will need additional clinical data to evaluate the benefit/risk profile in refractory patients.