Biopharmaceutical company Lyric Pharmaceuticals reported on Wednesday the receipt of the US Food and Drug Administration's (FDA) Fast Track designation for the investigation of ulimorelin (LP101) for the treatment of enteral feeding intolerance (EFI) in critically ill patients.

According to the company, Ulimorelin, which is a macrocyclic agonist of the hormone ghrelin, is under clinical development as LP101 for the treatment of EFI as well as for other disorders affecting critically ill patients in the Intensive Care Unit (ICU). Ghrelin agonists may offer both gastrointestinal pro-motility and pro-metabolic effects in critically ill patients with EFI and their use may also mitigate muscle loss in these and other ICU patients.

EFI is reportedly a common ICU condition in which impaired gastric emptying prevents adequate enteral nutrition from being delivered. Reports indicate an EFI prevalence of over 30% in patients receiving enteral nutrition in the critical care setting. EFI is associated with significant morbidity and mortality.

In conjunction with the US FDA's fast track status, the company has completed two Phase 1 trials of LP101 demonstrating gastrointestinal prokinetic activity as shown by accelerated gastric emptying. The Phase 2 PROMOTE study of LP101 for the treatment of EFI, is currently enrolling, with data expected in mid-2018.

On 23-24 January 2018, the company's co-founder and chief medical officer Dr M Scott Harris will give two presentations at the upcoming 2018 meeting of the American Society of Enteral and Parenteral Nutrition (ASPEN) in Las Vegas, NV.

The company's ASPEN 2018 presentations are entitled "The Impact of Gastric Residual Volume (GRV), Vomiting and Other Signs of Intolerance on the Incidence of Enteral Feeding Intolerance in Critically Ill, Mechanically Ventilated, Tube-Fed Patients," and "The Role of Ghrelins in Preservation of Lean Body Mass and Promotion of Anabolic Responses in the Critically Ill Patient," presented as part of the annual Dudrick Symposium on Novel Therapeutic Strategies for Critical Care.