Preliminary analysis of the study results indicates DOV 21,947 was safe and well-tolerated at the doses examined and produced a significant decline in plasma triglyceride levels. The company intends to initiate a Phase II study for the treatment of depression in the fourth quarter of this year.
Prior studies with DOV 21,947 at up to 100mg per day demonstrated the safety and tolerability of the compound over dosing periods of up to ten days. The goal of the Phase Ib study was to confirm DOV 21,947’s safety and tolerability over an eight-week period at escalating doses of up to 150mg per day.
DOV says the significant reductions in plasma triglyceride levels observed during the conduct of this study are consistent with preclinical evidence that the compound is able to produce a significant and sustained reduction in both triglyceride levels and body weight in animal models of obesity. “These findings underscore the therapeutic versatility of triple reuptake inhibitors such as DOV 21,947,” said Dr Phil Skolnick, president and chief scientific officer of DOV.
This double-blind, placebo-controlled Phase Ib study enrolled 46 male and female subjects. Following a one-week placebo run-in, subjects received either escalating daily doses of 50mg, 100mg and 150mg of DOV 21,947 (31 subjects) or placebo (15 subjects), for a total of eight weeks. The study demonstrated that the compound was safe and well-tolerated in this dose range with no reported serious side affects.
The proportion of patients with treatment emergent adverse events was similar in the two treatment groups, with 36% and 47% in the DOV 21,947 and the placebo treated group, respectively.