Palatin Technologies (PTN) Announces FDA Clearance of IND Application for PL-8177 For Ulcerative Colitis

January 3, 2018 7:31 AM EST

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Palatin Technologies, Inc. (NYSE: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today announced that the U.S. Food and Drug Administration (FDA) has notified Palatin that it may proceed with its clinical investigation of subcutaneous injection PL-8177 as a potential treatment for patients with ulcerative colitis. The notice to proceed was received following Palatin's submission of an investigational new drug (IND) application for this program. Palatin expects to commence a Phase 1 single and multiple ascending dose study in the current quarter.

PL-8177, a selective melanocortin receptor 1 (MC1r) agonist peptide, is Palatin'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.

"The FDA's acceptance of this IND application is an important milestone for Palatin, as we accelerate our drug discovery programs following the successful licensing of bremelanotide for hypoactive sexual desire disorder," said Carl Spana, Ph.D., president and chief executive officer of Palatin Technologies. "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."

PL-8177 is a cyclic peptide that has demonstrated efficacy in animal inflammatory bowel disease models. Palatin has developed an oral formulation of PL-8177 that has been validated in animal studies, and is scheduled to be explored in future clinical investigations. PL-8177 is highly specific for MC1r, with sub-nanomolar affinity binding and EC50 functional values.

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