Galapagos initiates clinical studies with GLPG0492, a candidate drug for cachexia
Galapagos NV announced that it has initiated a first-in-human trial for GLPG0492, its candidate drug for cachexia (loss of weight and muscle mass) and potentially other indications, such as Duchenne muscular dystrophy.
GLPG0492 is an orally available small molecule that Galapagos has developed in its Selective Androgen Receptor Modulator (SARM) program. The candidate drug has been shown to improve muscle mass in animal models, with minimal cardiovascular, prostate, or virility side effects traditionally seen in androgen therapies. With the support of two foundations - Charley's Fund and the Nash Avery Foundation - Galapagos is currently evaluating the potential effectiveness of GLPG0492 in pre-clinical models of Duchenne muscular dystrophy.
"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, CEO 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."
The primary endpoints of this first-in-human trial will be to determine the safety, tolerability and pharmacokinetics of the candidate drug GLPG0492. The double-blind, single ascending dose study will be conducted in 16 healthy human volunteers in Belgium over the coming months, with results expected in the second half of 2010.
GLPG0492 binds with very high selectivity and affinity to targeted androgen receptors, potentially enabling the candidate drug to be efficacious without cardiovascular, prostate, or virility side effects traditionally seen in androgen therapies. Galapagos aims for once-a-day oral dosing that improves muscle mass and function, with minimal effects on hormonal status in patients. In pre-clinical studies, GLPG0492 has shown efficacy in the treatment of cachexia, while pre-clinical studies to evaluate the molecule's potential efficacy in Duchenne muscular dystrophy are on-going.
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