Positive Safety and Tolerability for Novel Potentiator GLPG1837
News Oct 10, 2015
Galapagos NV presents topline Phase 1 results with novel potentiator GLPG1837 at the North American Cystic Fibrosis Conference (NACFC) in Phoenix this week. GLPG1837 was shown to be safe and well-tolerated and demonstrated favorable drug-like properties in the study.
GLPG1837 is a candidate drug for the treatment of the Class III mutation in cystic fibrosis. It is expected that GLPG1837 will be combined with other Galapagos candidate drugs to create a potential triple combination therapy for Class II patients, the largest CF-patient group.
Galapagos conducted a randomized, double-blind, placebo-controlled study over a range of single and multiple doses of GLPG1837 in healthy human volunteers in Belgium. In the single ascending dose (SAD) part of the study subjects were exposed to single oral doses of 30 to 2000 mg. In the multiple ascending dose (MAD) part of the study, GLPG1837 was given orally at doses of 125 to 800 mg twice daily for a period of 14 days.
On safety, GLPG1837 up to a single dose of 2000 mg and up to 800 mg twice daily for 14 days was generally safe and well tolerated in this study. There were no adverse effects observed on ECG, vital signs, or on laboratory parameters. Treatment-emergent adverse events were rare, with the most common adverse events reported being headache and tiredness.
The pharmacokinetics of GLPG1837 also proved favorable in this study. Rapid absorption occurred, with a mean apparent elimination half-life of 6-15 hours. The bioavailability of GLPG1837 was improved with food. Steady state was attained within the second dosing, with no accumulation.
The company believes the results from this Phase 1 study support rapid progression into a Phase 2 study in Class III mutation patients, which is expected to commence before year end 2015.
PhoreMost and Plexxikon Collaborate to Identify Novel Drug TargetsNews
PhoreMost, the UK-based biopharmaceutical company dedicated to drugging ‘undruggable’ disease targets, today announced it has signed a collaborative agreement with Plexxikon Inc., the small molecule structure-guided R&D centre of Daiichi Sankyo.READ MORE
Anti-Malaria Drugs Delivered With CaffeineNews
Many drug delivery systems, such as capsules and tablets, can be difficult to swallow, especially for children. Making delivery systems out of polymer gels is an attractive option, but usually requires hazardous levels of heavy metals to be used. Now, scientists have found a way to build these gels from caffeine molecules.READ MORE
Lonza Opens World’s Largest Dedicated Cell-and-Gene-Therapy Manufacturing Facility in TexasNews
First-of-its-kind, state-of-the-art manufacturing facility with capacity to produce treatment for thousands of patients suffering from rare genetic disorders or life-threatening diseases.READ MORE
Comments | 0 ADD COMMENT
World Congress on Advanced Biomaterials and Tissue Engineering
Jun 20 - Jun 21, 2018