Saniona announced that it has completed the 3-month treatment period in adolescent patients in the second part of its Phase 2a study of Tesomet to treat Prader Willi syndrome (PWS). The first part of the study included nine adult patients and was successfully concluded in 2018. The second part of the study included nine adolescent patients, who have now completed the treatment period. The treatment appeared to be well tolerated and Saniona expects to report data from this placebo-controlled Phase 2a trial in the first quarter of 2019. Eight of the nine adolescent patients have agreed to continue in a 24-week extension study, which was recently authorized. The study is an exploratory randomized, double-blind, placebo-controlled Phase 2a trial. In the second part of the study, adolescent patients received either Tesomet or placebo at a 3:2 randomization. The primary endpoint of the study is to examine the change in bodyweight over 12-weeks of treatment with Tesomet compared to placebo. Secondary objectives include eating behavior and food craving (hyperphagia), body composition, lipids and other metabolic parameters. The study remains blinded until the final data have been collected from the central laboratories. Top-line data is expected to be communicated during the current quarter. The first part of Saniona's Phase 2a study in PWS included nine adult patients and was successfully concluded in 2018. The results from the first part of the study revealed that Tesomet may provide clinically meaningful weight loss and a significant reduction in hyperphagia in adult patients (0.50 mg tesofensine). In addition, the half-life of Tesomet was observed to be longer than expected in the PWS patient population. As a result, a lower dose was chosen for the second part of the study in the adolescent patients (0.125 mg tesofensine).