Trial to Explore Use of Tesofensine Combination in Patients with Hypothalamic Obesity


Plans for a clinical phase 2a trial to test a combination of tesofensine and metoprolol (Tesomet) for the treatment of hypothalamic obesity in both the United States and Europe are underway.

This morning, Saniona announced its plan to commence a clinical phase 2a trial with its product, a combination of tesofensine and metoprolol (Tesomet), for the treatment of hypothalamic obesity in both the United States and Europe.

Tesomet is also being developed for the treatment of Prader-Willi syndrome based on the overlapping similarities between the 2 rare eating disorders, such as clinical symptoms, clinical trial design, and potential orphan drug designation. The clinical studies in patients with hypothalamic obesity are being planned by Saniona in collaboration with several leading academic centers in Denmark.

“We have recently reported positive results from preclinical studies for Tesomet and from a phase 1 study with our new patented Tesomet tablet. These two important stepping-stones enable us to perform long-term clinical studies with Tesomet,” Saniona’s CEO Jørgen Drejer said in a recent statement. “We are aiming at developing Tesomet for severe eating disorders including Prader-Willi syndrome and hypothalamic obesity in the US and Europe. Both Prader-Willi syndrome and hypothalamic obesity are rare diseases characterized by a constant craving for food with severe consequences for the patients.”

Hypothalamic obesity is a rare disease characterized by insatiable hunger. It is often caused by the surgical removal of a brain tumor, which results in damage to the hypothalamus—the appetite center in the brain—and results in morbid obesity. Patients with hypothalamic obesity often experience overlapping symptoms with Prader-Willi syndrome patients.

Tesofensine has been tested in over 1,300 patients and has been found to be very well-tolerated, according to Saniona. Previously evaluated in a phase 2a trial, investigators found the use of tesofensine to result in highly statistically and clinically meaningful weight loss in patients with Prader-Willi syndrome.

The weight loss is thought to have resulted from the drug’s “triple mode of action,” which includes the following: appetite normalization, reduced food craving, and increased metabolic rate. Because of this, Saniona posits that the drug could be beneficial for several metabolic syndromes, such as obesity, type 2 diabetes, fatty liver diseases (including nonalcoholic steatohepatitis (NASH), and other eating disorders.

“We will obtain several advantages of pursuing the development of Tesomet in the two indications. Prader-Willi syndrome and hypothalamic obesity have many things in common including clinical symptoms, clinical trial design, regulatory advantages from potential orphan drug designation and premium pricing as well as fast time to market due to relative short and small clinical studies,” added Jørgen Drejer.

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