Biopharmaceutical company Palatin Technologies Inc (NYSE American:PTN) announced on Tuesday that it has received 'orphan drug' designation from the US Food & Drug Administration (FDA) for PL7737, an oral treatment that activates the melanocortin-4 receptor, for leptin receptor (LEPR) deficiency, including obesity caused by this condition.
PL7737, an MC4R agonist, is designed to restore impaired signalling caused by these genetic mutations.
Carl Spana, PhD, Palatin president and CEO, said: "This FDA orphan designation is a key step in developing Palatin's MC4R receptor agonists for rare obesity conditions. Currently, the only FDA-approved treatment for obesity due to leptin receptor deficiency is a daily injection. PL7737's oral form could provide a more convenient and effective option for these patients and others with rare genetic obesity disorders. We are also exploring PL7737 for hypothalamic obesity and plan to begin a Phase 1 SAD/MAD study in late 2025."
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