Phase III study of NS 2330 meets endpoints in obesity.- Saniona.

Saniona announced statistically and clinically significant weight loss for both doses of NS 2330 (tesofensine) compared to placebo in its Phase III Viking study with oral tesofensine in obesity. By demonstrating significant and superior weight loss for both doses of tesofensine compared to placebo, the trial achieved its primary objective. In general, tesofensine was very well tolerated with low incidence of adverse events. Data shows that ten per cent average weight loss in 24 weeks and more than half of patients lost more than ten per cent in weight. There were statistically significant reduction in key obesity-related risk factors. Partner Medix, which owns commercial rights in Mexico and Argentina, will now prepare regulatory filings in those territories. Results support the development of Saniona�s wholly-owned Tesomet comprising tesofensine and currently in Phase II for rare eating disorders.

The 24-week double-blinded, randomized, placebo-controlled trial investigated the efficacy and safety of once-daily 0.25 and 0.50 mg oral tesofensine compared to placebo in 372 obese patients. The study�s primary endpoint was the average percentage and absolute change in body weight compared to placebo.