Tesomet is a combination of tesofensine and metoprolol, which currently is being tested in a Phase 2a study for treatment of type 2 diabetes. Administration of tesofensine has previously been investigated in a Phase 2 study where it demonstrated a highly statistically and clinically meaningful weight loss in obese patients. It is believed that this large magnitude of weight loss is driven by the triple mode of action including normalization of the appetite, reduction in the craving for food and an increase in fat utilization. Due to the mode of action of Tesomet, Saniona believes that it potentially may be used for treatment of a number of metabolic syndromes and eating disorders including Prader-Willi syndrome (PWS), binge eating, type 2 diabetes and fatty liver diseases including NASH.
PWS is recognized as the most common genetic cause of life-threatening obesity. The disease results from a deletion or loss of function of a cluster of genes on chromosome 15, which leads to dysfunctional signalling in the brain’s appetite/satiety center (hypothalamus). Patients suffer from a constant, extreme, ravenous insatiable appetite which persists no matter how much the patients eat. As a result, many of those affected with PWS become morbidly obese and suffer significant mortality. Compulsive eating and obsession with food usually begin before age 6 and currently there is no cure for this disease.
Saniona plans to initiate a Phase 2a study for Tesomet in patients with PWS during the first half of 2017. The study is expected to take approximately a year and may potentially pave the way for initiating a Phase 3 study. PWS is an orphan disease and Saniona plans to apply for orphan disease designation to both the EMA and FDA.
The tesomet product is covered by several patent applications and certain issued patents which together may provide patent protection until 2036.