9 Meters Biopharma, Inc. (NASDAQ: NMTR), a clinical-stage rare and unmet needs-focused gastroenterology company, today announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation to NM-003, a proprietary long-acting GLP-2 receptor agonist, for prevention of acute graft versus host disease.

NM-003, also called teduglutide, is designed as a long-acting injectable glucagon-like-peptide-2 (GLP-2) receptor agonist that utilizes proprietary XTEN technology to extend circulating half-life.

"We continue to evaluate the applicability of our long-acting GLP-2 for aGvHD, which presents a danger to transplant recipients and which lacks effective pharmaceutical options for prevention or treatment. Additionally, we plan to move to IND-enabling development stages next year, for the orphan indication or indications in which it can best improve treatment landscapes for underserved patients," said Patrick H. Griffin, M.D., Chief Medical Officer of 9 Meters Biopharma.

The FDA Office of Orphan Products Development (OOPD) grants orphan designation to advance the evaluation and development of safe and effective drugs and biologics to treat, prevent or diagnose rare diseases affecting fewer than 200,000 people in the U.S. Under the Orphan Drug Act, orphan designation qualifies drug sponsors for development incentives conferred by the FDA, including tax credits for qualified clinical testing. For more information about orphan designation, please visit the FDA website here.