The FDA has granted an investigational new drug application for a potential ulcerative colitis treatment, permitting the manufacturer to proceed with its clinical investigation, according to a press release from the company.
PL-8177 (Palatin Technologies) is a selective melanocortin receptor 1 (MC1r) agonist peptide and the company’s lead clinical development candidate for ulcerative colitis and other inflammatory bowel diseases.
“Agents that modulate the MC1r system may have therapeutic potential in a variety of inflammatory disease indications,” according to Palatin. Additionally, the company’s CEO said it has multiple development programs for melanocortin-based therapeutics.
The company said it expects to begin a phase 1 single and multiple ascending dose study this quarter. It will test the cyclic peptide, which has shown efficacy in animal models, as a subcutaneous injection for the treatment of UC, but the company has developed an oral formulation, also validated in animal models, that it plans to evaluate in future clinical studies.