Date: 2011-07-20
Type of information: Initiation of preclinical development
phase: 1
Announcement: initiation
Company: Galapagos (Belgium)
Product: GLPG0492
Action
mechanism: GLPG0492 is a selective androgen receptor modulator (SARM).
Disease: cachexia
Duchenne muscular dystrophy
Therapeutic area: Genetic diseases - Neuromuscular diseases - Rare diseases
Country:
Trial
details: 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.
Latest
news: Galapagos 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.
* On April 18, 2012, Galapagos gave an R&D update, indicating progress and plans for its portfolio. The company announced that a biomarker effect similar to that of oxandrolone was observed, but the data were insufficient for Galapagos to pursue GLPG0492 further in cachexia. With the financial support of Charley's Fund and the Nash Avery Foundation, improvement of muscle strength and running performance in a pre-clinical model of Duchenne muscular dystrophy (DMD) was shown with GLPG0492 in 2011. Galapagos intends to discuss with these patient organizations the opportunity for them to develop GLPG0492 further in DMD.
