Galapagos Begins Phase I Trial for Cachexia Drug

Galapagos NV has initiated a Phase I trial for GLPG0492, its candidate drug for cachexia (loss of weight and muscle mass) and potentially other indications, such as Duchenne muscular dystrophy.

The primary endpoints of the trial will be to determine the safety, tolerability and pharmacokinetics of GLPG0492. The double-blind, single ascending dose study will be conducted in 16 healthy human volunteers, with results expected in 2H10.

GLPG0492 is an orally available small molecule developed in the company’s Selective Androgen Receptor Modulator (SARM) program. The drug has been shown to improve muscle mass in animal models, with minimal cardiovascular, prostate, or virility side effects traditionally seen in androgen therapies.

“GLPG0492 marks the fifth candidate drug to enter the clinic for Galapagos, since initiating our first clinical trial in March 2009,” said Onno van de Stolpe, chief executive officer of Galapagos. “GLPG0492 has demonstrated an improvement in muscle mass in pre-clinical studies and therefore has the potential to be efficacious in treating diseases where loss of muscle mass is severe, such as cachexia and Duchenne.”