AGMB-447

AGMB-447 is an investigational, inhaled small molecule designed as a lung-restricted inhibitor of activin receptor-like kinase 5 (ALK5, also known as TGFβRI), the type I receptor for transforming growth factor-beta (TGFβ). It is being developed by Agomab Therapeutics for the treatment of idiopathic pulmonary fibrosis (IPF) and potentially other fibrotic respiratory diseases. The drug is formulated to be administered via nebulizer, targeting its activity specifically to the lungs while minimizing systemic exposure through rapid hydrolysis in plasma. By inhibiting ALK5 in the respiratory tract, AGMB-447 aims to block TGFβ-driven profibrotic signaling—a key driver of fibrogenesis in IPF—thereby reducing or reversing lung fibrosis. As of June 2024, AGMB-447 has received FDA Orphan Drug Designation for IPF and is undergoing evaluation in a Phase 1 clinical trial assessing safety, tolerability, pharmacokinetics, and pharmacodynamics in both healthy volunteers and patients with IPF[1][2][3][4][5][6][7][8].