Regeneron announced Wednesday that a Phase III study of Arcalyst (rilonacept) met its primary endpoint of decreasing the number of gout flares in patients with the condition, compared to placebo. The company also noted that in a second Phase III study, the drug failed to improve pain relief in patients with gout, compared to those who received standard therapy.
The PRE-SURGE 1 trial randomised 241 patients with gout to receive one of two dose regimens of Arcalyst or placebo for 16 weeks. The company said that patients who received the higher dose of Arcalyst had an 80-percent decrease in the number of gout flares over the treatment period, compared to placebo, while patients who took the lower dose of the drug experienced a 73-percent reduction in gout flares. In addition, patients treated with Arcalyst were up to 88 percent less likely to experience two or more gout flares during the study period.
In the SURGE trial, 225 patients who were experiencing a gout flare were randomised to receive either Arcalyst, Arcalyst plus standard therapy of indomethacin, or indomethacin alone. Results demonstrated that patients treated with Arcalyst plus indomethacin had a reduction in patient-reported pain score of 1.55 points from baseline, compared to 1.4 points in patients who took indomethacin alone, a difference that the company noted was not significant.
Regeneron said depending on the results of two additional ongoing studies of Arcalyst as a preventive therapy, it plans to file for regulatory approval by mid-2011.
RBC Capital Markets analyst Michael Yee called the results a "net positive in general," noting that the prevention data are robust. He added that the market size for flare prevention is a few hundred million dollars, though the main challenge will be to persuade doctors to prescribe the drug upfront.
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