Lyric Pharma Granted FDA Fast Track Designation for Lead Product Ulimorelin for Enteral Feeding Intolerance (EFI)

SOUTH SAN FRANCISCO, Calif., Jan. 17, 2018 /PRNewswire/ -- Lyric Pharmaceuticals, Inc (Lyric), a biopharmaceutical company, today announced that the United States Food and Drug Administration (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 (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 over 30 percent in patients receiving enteral nutrition in the critical care setting. EFI is associated with significant morbidity and mortality. No drug is approved for EFI in any market.  Currently in the U.S. and E.U., off label medications are prescribed approximately one million times per year to manage EFI, yet these drugs have well characterized and widely recognized toxicities. 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.

"Lyric is the only company currently conducting clinical studies of ghrelin agonism in the ICU," said David Wurtman, M.D., M.B.A., chief executive officer of Lyric. "Ghrelin is known as the 'feeding hormone,' and LP101, a potent ghrelin agonist, may offer important benefits to the numerous patients with EFI and altered metabolic status in the ICU. Fast Track status from the FDA confirms the importance of our initial development for EFI, an unmet medical need."

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. To learn more about this study, please click here.

Lyric also announced today two presentations at the upcoming 2018 meeting of the American Society of Enteral and Parenteral Nutrition (ASPEN) in Las Vegas, NV, on January 23^rd and 24^th by its co-founder and chief medical officer, M. Scott Harris, M.D. The first presentation will detail incidence rates of EFI in ICU patients from a prospective study conducted at the Hospital Universitario de Torrevieja in Torrevieja, Spain. The second presentation will be a discussion of the potential role of ghrelin and ghrelin agonists in the preservation of muscle mass in critically ill patients.

The 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.

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.

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.

RELATED LINKS
http://www.lyricpharma.com

SOURCE Lyric Pharmaceuticals, Inc.