Galapagos initiates Proof-of-Mechanism clinical study for candidate cachexia drug GLPG0492
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Galapagos NV announced that it has started a Phase I Proof-of-Mechanism study for GLPG0492, a candidate drug for cachexia (loss of weight and muscle mass) and potentially other indications, such as Duchenne muscular dystrophy.
This Proof-of-Mechanism study follows the positive outcome of the first-in-human trial conducted for GLPG0492, which showed good safety and a pharmacokinetic (PK) profile supporting once-daily oral dosing. The Proof-of-Mechanism study aims to assess GLPG0492's effect on muscle function in healthy volunteers.
"This is the third time this year we initiate a clinical study designed to give insight into the potential clinical benefits of a candidate drug," said Piet Wigerinck, SVP Development. "We aim to finalize this study by the end of 2011 before further evaluating the compound in a patient population."
Galapagos plans to conduct the placebo-controlled, multiple ascending dose study in at least 24 healthy volunteers using a once daily dosing regimen for two weeks. The study will include early measurements of muscle function. In addition to Proof-of-Mechanism investigation, the safety, tolerability and pharmacokinetics of GLPG0492 will be assessed further.
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