Galapagos Candidate Cachexia Drug, GLPG0492, Shows Good Safety and Profile Suitable for Once-Daily Oral Dosing
News Dec 03, 2010
Galapagos NV announced that it has successfully completed the 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. The candidate drug showed good safety in healthy volunteers and a pharmacokinetic (PK) profile which supports once-daily oral dosing.
In this first-in-human trial, healthy volunteers were given increasing doses of candidate drug GLPG0492 by oral administration. Safety data were favorable with no severe adverse events or changes in vital signs and laboratory parameters reported. Changes in biomarker levels lasting more than 24 hours were consistent with once-daily oral dosing. Similar positive safety and dosing results were seen for elderly volunteers.
Galapagos plans to conduct a second Phase I trial in healthy volunteers in the course of 2011 to assess the safety and tolerability of GLPG0492 over at least 14 consecutive days. Based on this trial, a Proof of Concept study is scheduled for late 2011.
"We are encouraged by the promising results of this first clinical trial for GLPG0492," said Piet Wigerinck, Galapagos' SVP Development. "Comparable safety and PK profiles were seen for younger and elderly volunteers, the latter being particularly relevant for a therapeutic aimed at improving muscle function."
The cholesterol-lowering drugs called statins have demonstrated substantial benefits in reducing the risk of heart attacks and strokes caused by blood clots (ischemic strokes) in at-risk patients. Since statins are associated with a low risk of side effects, the benefits of taking them outweigh the risks, according to a scientific statement from the American Heart Association that reviewed multiple studies evaluating the safety and potential side effects of these drugs.READ MORE
Global Experts Meeting on Frontiers in Biosimilars and Biologics Congress
Oct 24 - Oct 26, 2019