According to a story from GlobeNewswire, the biotech company Saniona has recently announced plans to begin the design and initiation of a Phase 2a clinical trial study of its investigational product Tesomet.
This trial will measure the effectiveness of the drug in teating hypothalamic obesity, a rare eating disorder that presents similar symptoms to Prader-Willi syndrome. The two disorders share many characteristics, and Saniona hopes that Tesomet will effective against both.
Hypothalamic obesity is a change in the body’s weight retention and gain that results from damage to the hypothalamus, a small portion of the brain that plays a role in regulating certain hormones, body temperature, sodium-water balance, growth, weight, emotions, sleep, and milk production. The hypothalamus is closely connected to the functionality of the pituitary gland, and damage to the hypothalamus usually impacts the pituitary as well. One of the possible results is insatiable hunger which causes obesity. Damage to the hypothalamus that causes hypothalamic obesity is often the result of surgery to treat craniopharyngioma, a type of rare brain tumor that appears in children. Treating the tumor almost always results in surgery. Following surgery rates of hypothalamic obesity can be as high as 77 percent. As a result hypothalamic obesity is also called craniopharyngioma associated obesity. It is also called acquired Prader-Willi syndrome. To learn more about hypothalamic obesity, click here.
The announcement of Phase 2 trials comes following encouraging results from Phase 1 trials, which will allow for Tesomet to be tested more thoroughly in long-term studies. CEO Jørgen Drejer says that the company plans to seek approval in both the US and the EU for Tesomet. The company plans to work with multiple academic sites in Denmark in order to conduct the clinical trial. The similarities between hypothalamic obesity and Prader-Willi syndrome will make testing Tesomet for both a relatively simple process.
Saniona is a company that has dedicated itself to developing therapies for a variety of different illnesses and medical challenges, such as metabolic diseases, disease of the central nervous system, autoimmune diseases, and pain management. Many of its products currently in develop are based around the company’s research into ion channels.