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Find Clinical Drug Pipeline Developments & Deals for Metoprolol Tartrate
Tesomet (tesofensine), is a novel, proprietary molecule, and investigational fixed-dose combination therapy of, a triple monoamine reuptake inhibitor and metoprolol (a beta-1 selective blocker).
Tesomet (Tesofensine) is a serotonin–noradrenaline–dopamine reuptake inhibitor from the phenyltropane family of drugs, which is being developed for the treatment of obesity.
Adult patients receiving Tesomet achieved a statistically significant reduction in hyperphagia, as well as a reduction in body weight. Adolescent patients demonstrated dose-dependent reductions in hyperphagia and body weight in open-label extensions of the study.
The initiation of this Phase 2b clinical trial of tesomet represents the culmination of the significant work and primary endpoint of study is the percentage change in body weight from baseline to week 36.
Tesomet capsules contain two active ingredients as microspheres of fixed-dose combination therapy of tesofensine (triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker) used for treatment for hypothalamic obesity and Prader-Willi syndrome.
Adults receiving Tesomet demonstrated statistically significant reductions in body weight and improvements in waist circumference and glycemic control.
The company requested FDA feedback, and the FDA agreed with the company’s proposal but requested additional information regarding Tesomet manufacturing.
Saniona is currently planning to initiate a Phase 2b study of Tesomet in PWS in the first half of 2021. Saniona is also evaluating Tesomet for the treatment of hypothalamic obesity (HO) and plans to begin a Phase 2b trial in this indication in the first half of this year.
Saniona is preparing to start a Phase 2b study of Tesomet in Prader-Willi Syndrome this year. In a Phase 2a trial, adults patients receiving Tesomet achieved a significant reduction in hyperphagia and a clinically meaningful reduction in body weight at a dose of 0.5 mg/day.
Tesomet was well-tolerated in hypothalamic obesity patients throughout the duration of the 48-week trial, with no clinically meaningful differences in heart rate or blood pressure observed. All patients who entered the OLE study completed it.
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