US-based Lyric Pharmaceuticals has finished enrolling patients in a Phase II trial of LP101 (ulimorelin) for the treatment of enteral feeding intolerance (EFI) in critically ill patients.
The PROMOTE study enrolled 120 mechanically ventilated critically ill patients aged 18 years and above in whom EFI showed as a gastric residual volume measured at 500ml or more. The trial was conducted at sites in the US, Canada, Spain and the Netherlands.
During the trial, patients were randomised to receive either LP101 (a macrocyclic agonist of the hormone ghrelin) or metoclopramide.
Its primary efficacy objective is safety assessments and the evaluation of feeding success as measured by the proportion of patients’ daily protein prescriptions received through enteral nutrition.
PROMOTE lead investigator Daren Heyland said: “Enteral feeding intolerance is associated with significantly higher morbidity and mortality in patients with critical illness.
“Patients with EFI have lower nutritional intakes, fewer ventilator-free days, longer ICU stays, and higher 60-day mortality.
“There is a serious unmet medical need for new drugs to treat this condition and ulimorelin holds considerable potential for these patients.”
EFI is an acute disorder of gastric motor function that develops in critically ill, enterally tube fed patients. The disease prevents patients from receiving prescribed enteral feeding.
LP101 is currently under development for the treatment of EFI and other disorders affecting critically ill patients in the intensive care unit (ICU).