



Palatin Technologies plans to start clinical trials of its ulcerative colitis therapy PL-8177 in the next three months. The U.S. Food and Drug Administration's decision to accept Palatin's Investigational New Drug application for the treatment opened the door to the trials. PL-8177 regulates a protein known as melanocortin receptor 1, which plays a role in inflammation and immune system response. A hallmark of ulcerative colitis is gut inflammation. It is also an autoimmune disease, or one in which the immune system attacks healthy tissue. Melanocortin receptor 1 levels are higher than normal in a number of diseases. These include the two inflammatory bowel diseases — Crohn's and ulcerative colitis — plus the kidney condition nephritis, rheumatoid arthritis and some skin disorders. When they are at normal levels, melanocortin receptor 1 proteins help fight inflammation and regulate the immune system. This suggests that PL-8177 could be used to treat a variety of inflammatory diseases, Palatin said. PL-8177 reduced the gut inflammation of animals with a bowel disease, preclinical-trial studies showed. "The FDA's acceptance of this IND [Investigational New Drug] application is an important milestone for Palatin," Dr. Carl Spana, president and chief executive officer of Palatin Technologies, said in a press release. "We are excited about the potential of modulating the melanocortin system in the treatment of a wide variety of diseases, and have multiple programs to develop melanocortin-based therapeutics for patients with inflammatory diseases." Palatin researchers administered PL-8177 orally in the animal studies that it conducted. It is now looking at developing an injected version of the therapy as well. In another ulcerative colitis d