MECHELEN, BELGIUM -- (Marketwire) -- 07/20/11 --
* Follows successful outcome of first-in-human clinical trial
* Proof-of-Mechanism study measures GLPG0492's effect on muscle function in healthy volunteers
Galapagos NV (Euronext: GLPG) announced today 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."
Details of the Phase I Proof-of-Mechanism study
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.
About candidate drug GLPG0492 and cachexia
GLPG0492 is a fully proprietary, orally available small molecule that Galapagos has developed in its selective androgen receptor modulator (SARM) program. In pre-clinical studies, GLPG0492 has shown efficacy in the treatment of cachexia, the involuntary loss of weight and muscle mass which can affect patients with diseases such as cancer, chronic obstructive pulmonary disease (COPD) and AIDS. It is estimated that worldwide more than two million people die annually from the consequences of cancer-related cachexia. Galapagos aims for once- a-day oral dosing that improves muscle mass and function, with minimal effects on hormonal status in patients.
Candidate drug GLPG0492 has been shown to improve muscle mass and function in animal models, with minimal cardiovascular, prostate, or virility side effects traditionally seen with androgen therapies. In a Phase I study in healthy volunteers, GLPG0492 showed good safety and a PK profile which supports once- daily oral dosing.
With the support of Charley's Fund and the Nash Avery Foundation, GLPG0492 also was tested in a pre-clinical model of Duchenne muscular dystrophy; this test showed an improvement of muscle strength and running performance.
Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size biotechnology company specialized in the discovery and development of small molecule and antibody therapies with novel modes-of-action. The Company is progressing one of the largest pipelines in biotech, with six programs in development and over 50 discovery programs. Through risk/reward-sharing alliances with GlaxoSmithKline, Lilly, Janssen Pharmaceutica, Roche and Servier, Galapagos is eligible to receive up to EUR2.5 billion in downstream milestones, plus royalties. The Galapagos Group has about 800 employees and operates facilities in six countries, with global headquarters in Mechelen, Belgium. More info at: www.glpg.com
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 Muscaritoli et al, Asia Pac J Clin Nutr 2008;17 (S1):387-390
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