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.
SER-287 is a new kind of drug made up of bacterial spores, or dormant bacteria. Under the right conditions, the spores produce bacteria that replace species that contribute to ulcerative colitis.
The FDA gives orphan drug status to therapies that companies are developing for rare diseases. The designation offers the companies incentives to continue developing the drugs and bringing them to market.