Pharmaceutical Business review

Epix obesity drug promotes weight loss

Findings from trial of obese, but otherwise healthy, adults demonstrated that adults taking 600mg of drug twice-daily (n=11) for 28 days lost an average of 0.45 kg (1 pound), while adults on placebo (n=10) gained 1.37 kg (3 pounds) during the same period; p<0.005. After 28 days of dosing, the average difference in weight in the intent-to-treat population between subjects receiving obese drug (PRX-07034) and those receiving matched placebo was 1.82kg; p <0.005. PRX-07034 was associated with a significant reduction in serum leptin levels, a marker of fat stores in the body (p<0.036). Overall, only one of the 10 subjects on placebo (10%) lost any weight during the trial, while seven of the 11 subjects on PRX-07034 (approximately 64%) lost weight. PRX-07034 appeared well-tolerated and there were no serious adverse events reported. Michael Kauffman, CEO of Epix, said: "We are very excited about the level of weight loss seen for PRX-07034 in an obesity indication. In this 28-day study, not only did the adults on PRX-07034 lose weight while those on placebo gained weight, but they were able to do so without any constraints on eating habits. We also note that subjects in this study did not follow any pre-specified dietary or exercise program."