Taste Assessment Study of Bivamelagon (MC72) Paediatric Solution Formulations

The melanocortin-4 receptor (MC4R, OMIM:155541) is a G protein-coupled receptor that is predominantly expressed in the hypothalamus and has a pivotal role in the regulation of satiety, feeding behaviour, and energy homeostasis through the leptin-melanocortin pathway.

Hyperphagia (insatiable hunger and abnormal food-seeking behaviours) and obesity may result from pathway impairment caused by genetic variants or hypothalamic injury.

Current treatment options for these forms of obesity are limited due to the failure of conventional weight management interventions, such as lifestyle modifications, to address the underlying hyperphagia and specific molecular mechanisms leading to continued weight gain.

Bivamelagon (MC72; LB54640) is an investigational small molecule agonist of MC4R and is being developed for once daily (QD) oral administration to treat MC4R pathway disease-related obesity. The current bivamelagon oral formulation consist of a hydrochloride salt that has a bitter taste.

The overall objective of this study was to evaluate the tasteprofile of reconstituted bivamelagon solutions to establishthe viability of simple flavouring and sweetening methodsfor taste masking an acceptable, age-appropriate oral liquid formulation for administration to paediatric patients.