Initiated IND-enabling toxicology program IND submission planned for 4Q25; Clinical data expected in 1H26 CRANBURY, N.J. , March 25, 2025 /PRNewswire/ -- Palatin Technologies, Inc.
(NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced the US Food & Drug Administration (FDA) has granted "orphan drug" designation to PL7737, an oral treatment that activates the melanocortin-4 receptor, for leptin receptor (LEPR) deficiency, including obesity caused by this condition. "This FDA orphan designation is a key step in developing Palatin's MC4R receptor agonists for rare obesity conditions," said Carl Spana , Ph.D.
, President and CEO of Palatin. "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." Dr. Spana continued, "Statistical analysis is now complete for our Phase 2 BMT-801 clinical study of the co-administration of MC4R bremelanotide + GLP-1 /GIP tirzepatide for the treatment of obesity, and for our Phase 2 clinical study of PL8177 oral formulation for the treatment of ulcerative colitis.
We look forward to releasing topline data results for both o.
