Lyric Chief Medical Officer Also Presenting on Role of Ghrelin Agonists in Critical Care
SOUTH SAN FRANCISCO, CA, January 23, 2018 – Lyric Pharmaceuticals, Inc (Lyric), a biopharmaceutical company, today announced the presentation at the ASPEN 2018 Nutrition Science and Practice Conference in Las Vegas, NV of data from a prospective study on the incidence of enteral feeding intolerance (EFI) in critically ill patients. EFI is a common Intensive Care Unit (ICU) condition in which impaired gastric emptying prevents adequate enteral nutrition from being delivered. EFI is associated with significant morbidity and mortality. No drug is approved to treat EFI in any market.
The study, conducted in a mixed medical-surgical ICU at Hospital de Torrevieja, Spain, examined the incidence of EFI using the updated guidelines for the definition of EFI from the Society of Critical Care Medicine, the American Society for Parenteral and Enteral Nutrition (ASPEN), and the European Society of Intensive Care Medicine. These guidelines all define a patient with EFI as one who demonstrates a gastric residual volume (GRV) of 500 mL or vomiting.
In this study, 84 patients who were expected to be enterally fed for four or more days and who met other inclusion and exclusion criteria were followed prospectively for the development of EFI. Patients were fed to 50 percent of their prescribed nutritional goals on Day 1 and then rapidly advanced to meet 100 percent of goal by Day 2. GRVs were measured every 12 hours; follow up was up to 10 days. Criteria for intervention included a GRV of 500 mL, or, vomiting. Medical interventions included prokinetic agents, small bowel feedings and parenteral nutrition.
32 (38.1%) patients developed EFI according to the pre-specified intervention criteria. Of these patients, 31 were treated with prokinetic agents. Mortality was higher in patients with GRV ≥ 500 mL vs. those without (54.2% vs. 36.7%).
This study demonstrates that using the updated guidelines for the definition of EFI, the incidence approaches 40 percent, and, that patients with EFI are at high risk for death from their illnesses.
Lyric is developing ulimorelin, a macrocyclic agonist of the hormone ghrelin, as LP101 for the treatment of EFI and for other disorders affecting critically ill patients in the ICU. PROMOTE, a Phase 2 study of LP101 for the treatment of EFI, is currently enrolling, with data expected in mid-2018. To learn more about this study, please click here.
“Feeding intolerance remains a common problem in the ICU patient population. Currently available prokinetic agents have questionable efficacy but unquestionable toxicity, including delirium, dyskinesia, antibiotic resistance, ventricular arrhythmias, and sudden cardiac death,” stated M. Scott Harris, chief medical officer of Lyric Pharmaceuticals. “There is an unmet need for newer agents to treat the condition. LP101, which has been observed in Lyric clinical trials to be a highly active prokinetic agent and to exhibit an acceptable safety profile thus far, holds promise for the treatment of this condition. The anti-inflammatory and pro-anabolic effects of ghrelin agonism may offer additional benefits by which critically ill patients might benefit from LP101 administration,” he added.
“This prospective study demonstrates the significant rate of EFI among critically ill patients when diagnosed in accordance with international guidelines,” said David Wurtman, M.D., M.B.A., chief executive officer of Lyric. “At present, physicians lack safe and effective treatments for EFI. LP101, currently in Phase 2 development, may enable physicians to overcome EFI and to provide the nutrition they’ve prescribed for their patients,” he added.
About LP101 (Ulimorelin)
Lyric’s proprietary product candidate, LP101 (ulimorelin), is a potent intravenous ghrelin agonist in Phase 2 for the treatment of EFI and other disorders of critical illness. LP101 has been administered to over 1000 patients and healthy volunteers with a favorable safety profile. LP101 is currently under assessment in PROMOTE, a Phase 2, randomized, multinational and multicenter trial, in the treatment of EFI. The FDA has granted Fast Track designation to the investigation of LP101 for the treatment of EFI.
About Enteral Feeding Intolerance
EFI is an acute disorder of gastric motor function developing in critically ill, enterally tube fed patients. EFI prevents patients from receiving prescribed enteral feeding. Critically ill patients are highly dependent on prescribed feedings to preserve their nutritional status and they develop EFI at a time when such nutrition is needed most. While EFI is of diverse etiologies, patients express similar clinical features that result from profound abnormalities in gastric emptying. EFI patients are severely catabolic and may lose as much as 22 percent of their skeletal muscle mass over a 10-day ICU stay. As a result, EFI patients follow similar paths of hospitalization, including longer ICU and hospital stay, increased time on ventilator, and, higher mortality. EFI is a worldwide disorder that affects approximately eight to 10 percent of all ICU patients. No safe and effective therapy is available or approved to treat the condition. Prokinetic agents such as metoclopramide (and domperidone ex-U.S.), as well as the antibiotic erythromycin, are commonly prescribed off-label but have been associated with significant toxicities and studies do not support their effectiveness in this use.
Lyric is a biopharmaceutical company developing novel therapeutics to address unmet medical needs affecting critically ill patients admitted to the intensive care unit. Lyric is developing an intravenous ghrelin agonist, LP101 (ulimorelin), for the treatment of enteral feeding intolerance, currently being evaluated in a Phase 2 clinical trial. Lyric investors include Third Point Ventures, RiverVest Ventures, Sante Ventures and Aperture Ventures. The company is based in South San Francisco, California.
Lyric Forward-Looking Statement
Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Lyric’s current perspective of existing trends and information as of the date of this release. For instance, any statements in this press release concerning prospects related to Lyric’s strategic initiatives are forward-looking statements. Actual results may differ materially from Lyric’s current expectations depending upon a number of factors affecting Lyric’s business. It is possible that the assumptions about these factors made by management for purposes of such statements may not materialize. Actual results may differ materially from those projected or implied in any forward-looking statements. Except as expressly required by law, Lyric disclaims any intent or obligation to update these forward-looking statements.
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SOURCE Lyric Pharmaceuticals, Incorporated