Lyric Pharmaceuticals which is a biopharmaceutical company asserted the completion of enlisting for PROMOTE Study which is an international multi-center, randomized, controlled Phase 2 Study of LP101 for the treatment of enteral feeding intolerance (EFI) in crtically ill patients.
LP101, which is an macrocyclic agonist of the hormone ghrelin, is under development for the treatment of EFI and other disorders affecting critically ill patients in the Intensive Care Unit.
EFI is a common ICU condition in which impaired gastric emptying prevents adequate enteral nutrition from being delivered. Published reports indicate an EFI prevalence of greater than 30 percent in patients receiving enteral nutrition in the critical care setting. EFI is associated with significant morbidity and mortality and no drug is approved for EFI in any market. Currently in the U.S. and E.U. off-label medications such as metoclopramide, the clinical standard of care, are prescribed approximately one million times per year to manage EFI, yet these drugs have well characterized and widely recognized toxicities.
PROMOTE, a double blinded study, enrolled 120 mechanically ventilated critically ill patients ages 18 years and above in whom EFI manifested as a gastric residual volume measured to be 500 mL or greater. Patients were randomized to receive either LP101 or metoclopramide. The study was conducted at sites in the United States, Canada, Spain and the Netherlands.
Daren Heyland, M.D., M.Sc., FRCPC, professor and director, Clinical Evaluation Research Unit, Kingston Health Sciences Centre, Kingston, Ontario, and lead investigator on the PROMOTE Trial said “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.”
Lyric’s proprietary product candidate, LP101, is a potent intravenous ghrelin agonist under development for the treatment of EFI and other disorders of critical illness. Lyric has previously completed two Phase 1 trials of LP101 demonstrating statistically significantly accelerated gastric emptying in healthy volunteer populations, versus placebo. LP101 has been administered to over 1000 patients and healthy volunteers with a favorable safety profile.