Tesomet for treatment of type 2 diabetes

Tesomet is a fix-dosed combination of tesofensine and metoprolol. Tesofensine provides robust weight loss in obese patients and in addition to treatment of obesity, tesofensine also has the potential to reverse the progression of type 2 diabetes by reducing liver fat. In general, tesofensine has been well tolerated in human clinical studies. However, an increase in heart rate has been observed at therapeutic relevant doses of tesofensine.

In 2015, Saniona published new results that metoprolol blunted the increase in heart rate caused by tesofensine in volunteers in a Phase 1 study and results from datamining of previous clinical studies, which show that tesofensine improved glycemic parameters in prediabetes individuals participating in a Phase 2 obesity study.

In 2016, Saniona performed a Phase 2a clinical trial for Tesomet in type 2 diabetes patients. Top line data from this clinical trial was presented in January 2017. The clinical trial achieved a positive outcome on the primary endpoint with a statistically significant reduction in heart rate for patients treated with Tesomet compared to placebo. Furthermore, the key secondary and exploratory endpoints regarding body weight and waist circumference also showed statistically significant reductions compared to placebo. Glycemic secondary endpoints were not statistically significantly different from placebo in this rather short 12-weeks study.

The new data together with data from previous clinical studies with tesofensine, supports the use of Tesomet as a safe and effective weight loss drug in patients with metabolic disorders like diabetes and obesity. Furthermore, the statistically significant reduction in weight loss and the numeric reduction in liver fat achieved in the Phase 2a type 2 diabetes study suggests that Tesomet may provide a clinical relevant reduction in glycemic parameters over a longer period and thereby represent an interesting potential new treatment principle for type 2 diabetes.

Type 2 diabetes is considered as a progressive chronic disease today. However, recent published research concludes that large patient populations may undergo long-term remission if they achieve a substantial weight loss through reduced food consumption. According to Datamonitor, the market for type 2 diabetes is estimated to grow from US $ 23 billion in 2014 to 43 billion USD in 2023 of which weight-reducing therapy options will be the major value driver.

The tesomet product is covered by several patent applications and certain issued patents which together may provide patent protection until 2036.