French-based biopharmaceutical company Alizé Pharma will report results of its Phase II trial of AZP-531 to treat patients with Prader-Willi (PWS) syndrome.
AZP-531 is a stabilised analog of human unacylated ghrelin (UAG) developed to treat metabolic and cardiovascular disorders.
The randomised, double-blind, placebo-controlled Phase II trial is designed to evaluate the safety and efficacy of AZP-531 against placebo after it is administered for two weeks.
The trial involved 47 patients with genetically diagnosed PWS and evidence of hyperphagia.
Initial top-line results of the Phase II trial released in April have displayed improvement within food-related behaviour, which was determined by the PWS Hyperphagia Questionnaire and further validated by a reduction in patient-reported appetite.
Improvement has also been noted on glucose control along with a reduction in waist circumference and fat mass.
AZP-531 maintained a tolerable profile throughout the trial with no serious or severe adverse events reported.
PWS is a rare genetic disease, with onset occuring from early childhood.
The disease is characterised by abnormal eating behaviours including obsessive food seeking, food storage, foraging and hoarding.
AZP-531 controls food consumption induced by acylated ghrelin (AG) while reducing fat deposition and improving glucose control.
It inhibits the metabolic effects triggered by the abnormally high AG levels observed in PWS.
Image: 15 year old afflicted with PWS. Photo: courtesy of Schüle B et al via Wikipedia.