Dov Pharmaceutical Announces Phase Ib Results for DOV 21,947
Dov Pharmaceutical announced Phase Ib results for DOV 21,947, its lead triple reuptake inhibitor for the treatment of depression and obesity.
According to Dov, the double-blind, placebo-controlled study enrolled 46 subjects. Following a one-week placebo run-in, subjects received either escalating daily doses of 50, 100 and 150 mg of DOV 21,947 (31 subjects) or placebo (15 subjects), for a total of eight weeks, the company added.
Preliminary analysis indicates DOV 21,947 was safe and well-tolerated at the doses examined and produced a significant decline in plasma triglyceride levels, the company said.
According to the company, the proportion of patients with treatment emergent adverse events was similar in the two treatment groups, with 36 percent and 47 percent in the DOV 21,947 and the placebo treated group, respectively.
Reported adverse events with greater than 3 percent incidence in both the DOV 21,947 and placebo treated arms included headache, nausea, diarrhea and dizziness, the company said.
The incidence of subjects that dropped out of the study due to adverse events was 6.5 percent and 13.3 percent in the DOV 21,947 and placebo-treated group, respectively, the company added.
The company said it intends to initiate a Phase II study of DOV 21,947 for the treatment of depression in the fourth quarter.