According to a recent article in the Globe, the Danish biotech company Saniona AB has initiated a Phase 2a clinical trial of Tesomet for the treatment of hypothalamic obesity, a rare and severe eating disorder.
Saniona is concurrently conducting a Phase 2a study of Tesomet for the treatment of Prader-Willi Syndrome (PWS) that exhibits similar characteristics to hypothalamic obesity. Results of the PWS study are expected in the first quarter of 2019.
About the Hypothalamic Obesity Study
The trial is primarily designed to study the safety and efficacy of Tesomet on hypothalamic obesity. Results are dependent upon blood pressure and heart rate, lab data, and adverse reactions.
Effects of Tesomet will also be observed with regard to:
- Weight loss
- Degree of tolerability
- Patient’s appetite during the trial and food cravings
- Body weight and composition
- Lipids and metabolic parameters
- General quality of life (QOL)
This exploratory randomized double-blind placebo-controlled trial will include approximately 25 patients and will be held at the Company’s Copenhagen location. The trial period will consist of twenty-four weeks followed by an open-label twenty-four-week segment in which all patients will receive Tesomet. Additional information about the trial is available here.
About Hypothalamic Obesity
Hypothalamic obesity is caused by damage to the hypothalamus that controls body functions such as body temperature and hunger. The hormones produced by the hypothalamus are responsible for sleep, body temperature, and appetite as well as controlling the pituitary gland.
Symptoms vary and can include uncontrollable hunger, and rapid, excessive weight gain.
PWS patients also exhibit problems with the inability to control their food intake. The similarities extend to clinical trials and regulations. For this reason, Saniona is conducting concurrent trials.
Tesofensine is the active ingredient in Tesomet that was developed by a Danish company to treat obesity.
It was originally developed to treat Parkinson’s and Alzheimer’s disease but the studies were not successful.
However, when it was noted that the heavier Parkinson’s patients experienced weight loss, the company changed its target from Parkinson’s disease to obesity.
Thus far clinical trials indicate that Tesomet may prove to be more successful than other weight loss products currently on the market. Additional information about Tesomat (tesofensine) is available here.
Disorders Associated with Obesity
- increased risk of cardiovascular disease
- Type 2 Diabetes
- Increased risk of certain cancers
- changes in blood lipid and cholesterol levels leading to atherosclerosis
The significant increase in type 2 Diabetes is largely associated with the rise in obesity. The obesity rate is one person in every five in the U.S. In some areas of Europe approximately seventy percent of men and women over age 50 are either overweight or obese. Additional information is available here.
Saniona 2019 Targets
Saniona AB, a biotech company headquartered in Denmark, is known for its work in central nervous system diseases and various eating disorders. Currently, it is sponsoring four clinical trials, including hypothalamic obesity and Prader-Willi syndrome, in preparation for one or more Phase III pivotal trials beginning this year.
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Rose Duesterwald March 14, 2019