Date: 2015-10-09
Type of information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the North American Cystic Fibrosis Conference (NACFC) in Phoenix
Company: Abbvie (USA - IL) Galapagos (Belgium)
Product: GLPG1837
Action mechanism:
Disease: cystic fibrosis
Therapeutic area: Rare diseases - Genetic diseases
Country: Belgium
Trial details:
Latest
news: * On October 9, 2015, Galapagos has presented 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. * On December 19, 2014, Galapagos announced the initiation of the first Phase 1 study with GLPG1837. This novel potentiator is designed as a CFTR targeted therapy for cystic fibrosis patients who carry class III/IV mutations (e.g., G551D). In combination with corrector GLPG2222, this potentiator will also be developed for patients affected by the F508del mutation, the most prevalent mutation in CF patients. This achievement triggers a milestone payment of $10 million from AbbVie. The aim of the Phase 1 study is to evaluate the safety, tolerability and pharmacokinetics of oral single and multiple ascending doses of GLPG1837. The randomized, double-blind, placebo-controlled, single center study is being conducted in at least 40 healthy volunteers in Belgium. In the first part of the study, single ascending doses will be evaluated. In the second part, the new compound will be administered daily for 14 days. Topline results from this Phase 1 study with GLPG1837 are expected in the second half of 2015. Galapagos initiated its research in CF in 2005. In September 2013 Galapagos signed an agreement with AbbVie in which they will work collaboratively to develop and commercialize oral drugs that address the main mutations in CF patients, including F508del and G551D. Under the terms of the agreement, AbbVie made an upfront payment of $45 million to Galapagos. Upon successful completion by Galapagos of clinical development through to completion of Phase II, AbbVie will be responsible for Phase III, with financial contribution by Galapagos. Galapagos is eligible to receive up to $360 million in total additional payments for developmental and regulatory milestones, sales milestones upon the achievement of minimum annual net sales thresholds and additional double-digit royalty payments on net sales.
