FDA News

FDA clears study of potential UC therapy

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.

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.

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