Publication date: 24/04/2018
Galapagos NV (Euronext & NASDAQ: GLPG) announces initiation of its first clinical trial with an investigational triple combination therapy in cystic fibrosis patients.
The aim of the FALCON trial is to evaluate the efficacy, safety, tolerability, and pharmacokinetics of a novel triple combination in up to 24 CF patients. The open label trial is being conducted in multiple centers, initially in the United Kingdom with expansion expected to other European countries.
The FALCON study will comprise two parts. Part one will entail treatment of 8 patients for two weeks with a fixed dose dual combination of potentiator GLPG2451 and C1 corrector GLPG2222 in homozygous F508del patients. This will be followed by two weeks' treatment with '2451, '2222, and C2 corrector GLPG2737. Part two will entail treatment for two weeks with a higher dose dual combination of '2451 and '2222 in separate 8 patient cohorts of homozygous F508del patients and heterozygous F508del patients with a minimal function mutation on the other allele. This will be followed by two weeks' treatment with '2451, '2222, and '2737. Efficacy will be measured by changes in sweat chloride and percent predicted forced expiratory volume during the first second (ppFEV1%). Topline results from treatment in part one of FALCON are expected to be disclosed Q3 2018.
"Today marks a key milestone in our CF program. Since 2005, it has been our ambition to develop a disease-modifying therapy for CF. Now we are evaluating a first triple combination in CF patients, with the next triple combination coming up rapidly behind it," said Dr. Piet Wigerinck, CSO of Galapagos. "These steps bring us closer to our goal of offering patients, doctors, and payers more choice in their CF therapies."
GLPG2451, GLPG2222, GLPG2737 (and combinations thereof) are investigational therapies; their safety and efficacy have not been established.
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Galapagos' pipeline comprises Phase 3 through to discovery programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications. Our target discovery platform has delivered three novel mechanisms showing promising patient results in, respectively, inflammatory diseases, idiopathic pulmonary fibrosis and atopic dermatitis. Galapagos is focused on the development and commercialization of novel medicines that will improve people's lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 600 employees, operating from its Mechelen, Belgium headquarters and facilities in the Netherlands, France, Switzerland, the US and Croatia. More information at www.glpg.com.