Closely-held Saniona of Denmark has obtained approval to initiate the second part of its Phase 2a trial for Tesomet in adolescents with Prader-Willi syndrome (PWS), the most common genetic cause of life-threatening obesity.
Tesomet has the potential to reduce weight and hyperphagia, characterized by an extreme and insatiable appetite in PWS patients – a major, debilitating problem for these patients and their caregivers.
“We are excited to continue advancing Tesomet’s clinical development for Prader-Willi syndrome following encouraging results from our exploratory Phase 2a study in adult patients and positive discussions with key opinion leaders in the field,” Jørgen Drejer, CEO of Saniona, said in a statement.
“We believe that low dose Tesomet could prove to be a compelling treatment for adolescents with this currently untreatable disease,” he added.
This exploratory randomized, double-blind, placebo-controlled Phase 2a study in patients with PWS was initiated in April 2016 and divided into two parts.
In 2017, Saniona completed the first part of the study, which included nine adult patients. The results revealed that Tesomet might provide clinically meaningful weight loss and a significant reduction in hyperphagia.
The second part of this study may potentially include up to 10 adolescents with PWS, with a primary endpoint examining the change in bodyweight over 12 weeks of treatment, compared with placebo. Secondary objectives are to examine eating behavior and food craving, body composition, lipids and other metabolic parameters.
Dr. Roman Dvorak, CMO, said the data supporting Tesomet for Prader-Willi patients has been impressive. “During the first 3-month study, patients not only experienced a significant weight loss but also a remarkable reduction in cravings, measured by the hyperphagia questionnaire. We are now continuing the study at a lower dose in adolescents with PWS,” he added.
