Date: 2017-09-18
Type of
information: update on patient enrollment
phase: 3
Announcement: update on patient enrollment
Company: Saniona (Denmark) Medix (Mexico)
Product: tesofensine
Action
mechanism:
- monoamine uptake inhibitor. Tesofensine, a monoamine uptake inhibitor, is focused on obesity. Pathological overeating and obesity can be caused by decreased dopamine function in the reward centre of the brain. Dopamine transporter proteins are inhibited by tesofensine, so the dopamine receptors are stimulated for a longer period after activation and the brain's reward system is amplified. With a similar mechanism of action tesofensine also increases levels of two other monoamines, serotonin and noradrenaline.
Each of these transmitters exert an important function on appetite and metabolism at different locations in the brain. Dopamine acts in the nucleus accumbens of the forebrain to modulate reward and the "pleasure"-feeling of food. The two other transmitters act in the hypothalamus to increase metabolism and reduce appetite.
The unique efficacy of tesofensine in obesity may be explained by reversal of blunted dopamine response in obese patients. In obese individuals, the brain centre (striatum) controlling consummatory food reward dopamine receptors are reduced relative to lean individuals. It has been found that in the relevant brain region more than 70% of obese individuals have a blunted dopamine response to food intake.
- Tesofensine has been evaluated in Phase 1 and Phase 2 human clinical studies with the aim of investigating treatment potential with regards to obesity, Alzheimer’s disease and Parkinson’s disease. Tesofensine demonstrated strong weight reducing effects in Phase 2 clinical studies in obese patients. In general, tesofensine was well tolerated in humans. However, blood pressure and heart rate increased at therapeutic doses of tesofensine. A recent patent application covering the combination of tesofensine and metoprolol has been filed. The patent claims are based on the demonstration in preclinical studies that the robust weight reduction seen with tesofensine is maintained when co-treatment with a beta-blocker was used to eliminate heart rate and blood pressure increase by tesofensine.
Disease: obesity
Therapeutic
area: Metabolic diseases
Country: Mexico
Trial
details:
Latest
news:
- • On September 18, 2017, Saniona announced that its partner, Medix, has recruited 150 out of the planned 372 patients in the study during the first six weeks. This randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 clinical trial will include up to 372 ambulatory adult patients with obesity. The patients are randomized into three arms with 124 patients in each arm receiving either 0.25 mg tesofensine, 0.5 mg tesofensine or placebo tablets once daily. The study starts with a 2-week run-in period followed by 24 weeks treatment period and a 12 week follow up period.
- The study is conducted by Medix at two of their clinical sites in Mexico. The primary endpoint is absolute and percent change in body weight over the treatment period. Secondary endpoints include proportions of patients achieving a weight loss of more than 5 and 10 percent respectively, metabolic including glycaemic endpoints, as well as quality of life, comprehensive tolerability and safety evaluation.
- In February 2016, Saniona entered a collaboration with Medix about the development and commercialization of tesofensine and Tesomet in Mexico and Argentina. Medix will finance and be responsible for the clinical development and regulatory filings. Saniona retains all rights to tesofensine and Tesomet in the rest of the world, including the exclusive rights to use the clinical data developed by Medix.
Is
general: Yes
