APD209 is an oral, fixed dose combination formulation of megestrol and formoterol in clinical development for the management of cancer cachexia. Megestrol, a steroid, is a known appetite stimulant, and formoterol, a beta-2 agonist, is known to have anabolic effects on muscle.
A Phase 2a proof-of-concept clinical study with APD209 in advanced cancer patients with cachexia has been successfully completed and further clinical trials are planned.
Cachexia is a complex syndrome that occurs in around 50% of cancer patients and up to 80% of advanced cancer patients, and is characterised by loss of muscle and fat, weight loss, loss of appetite, fatigue and anaemia. Cancer cachexia is associated with shorter survival and reduced quality of life, and has been implicated as the cause of death in about 20% of patients with incurable cancer. There are no drugs approved for the management of cancer cachexia.