Axokine: Phase III

In a double-blind, placebo-controlled U.S. Phase III trial, the intent-to-treat analysis showed 25.1% of the 1,467 Axokine-treated patients lost at least 5% of baseline body weight compared to 17.6% of the 501 placebo-treated patients (p<0.001). Axokine patients lost an average of 6.2 pounds compared to 2.6 pounds for placebo patients (p<0.001). However, 70% of Axokine-treated patients developed anti-Axokine antibodies at the end of 1 year, which started after about 3 months of Axokine treatment. REGN said Axokine's efficacy in patients who did not develop antibodies was comparable to marketed obesity drugs. Analysis of 1,283 patients that completed 1 year of treatment showed that 120 of the 259 (46.3%) Axokine patients who did not develop antibodies lost at least 5% of their body weight compared to 73 of 304 (24%) placebo patients (p<0.001). Axokine patients negative for ...