Posted by Michael Wonder on 18 Jan 2018
Lyric Pharma granted FDA fast track designation for lead product ulimorelen for enteral feeding intolerance
17 January 2018 - Lyric Pharmaceuticals today announced that the United States FDA has granted fast track designation to the investigation of ulimorelin (LP101) for the treatment of enteral feeding intolerance (EFI) in critically ill patients.
Ulimorelin, a macrocyclic agonist of the hormone ghrelin, is under clinical development as LP101 for the treatment of EFI and for other disorders affecting critically ill patients in the Intensive Care Unit.
Lyric has completed two Phase 1 trials of LP101 demonstrating gastrointestinal prokinetic activity as shown by significantly accelerated gastric emptying. PROMOTE, a Phase 2 study of LP101 for the treatment of EFI, is currently enrolling, with data expected in mid-2018.
