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."
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA