Lyric Completes Enrollment in Phase 2 PROMOTE Study of LP101 (Ulimorelin) in Enteral Feeding Intolerance

SOUTH SAN FRANCISCO, Calif., March 5, 2018 /PRNewswire/ -- Lyric Pharmaceuticals, Inc. (Lyric), a biopharmaceutical company, today announced the completion of enrollment of PROMOTE, an international, multicenter, randomized, controlled Phase 2 study of LP101 (ulimorelin) for the treatment of enteral feeding intolerance (EFI) in critically ill patients. LP101, a 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 (ICU).

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. Ghrelin agonists such as LP101 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.

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. In addition to safety assessments, the primary efficacy objective was to assess feeding success as measured by the proportion of patients' daily protein prescriptions received through enteral nutrition. To learn more about this study, please click here.

"Enteral feeding intolerance is associated with significantly higher morbidity and mortality in patients with critical illness," said 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. "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."

"PROMOTE is a landmark study, the first of its kind to study a ghrelin agonist not only for EFI but also in the ICU setting," said M. Scott Harris, M.D., chief medical officer of Lyric. "LP101 has been observed in Lyric clinical trials to be a highly active prokinetic agent which could enable physicians to meet prescribed nutritional goals for their patients. The anti-inflammatory and pro-anabolic effects of ghrelin agonism could also offer this population of highly catabolic patients additional benefits that differentiate LP101 from other prokinetic agents currently prescribed for EFI," he added.

"Lyric anticipates data from PROMOTE by mid year.  With enrollment now completed, our focus is on planning the next EFI clinical study with LP101," said David Wurtman, M.D., M.B.A., chief executive officer of Lyric. "EFI is a large unmet medical need and Lyric is well positioned to develop both the first-in-class and best-in-class compound to treat this condition," he added.

About LP101 (Ulimorelin)
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. 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 which develops 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 stays, 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.

About Lyric (WWW.LYRICPHARMA.COM)
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.

SOURCE Lyric Pharmaceuticals, Inc.

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