Galapagos NV provides an update on progress made in the cystic fibrosis (CF) programs. Galapagos and AbbVie aim to develop a triple CFTR combination therapy to address 90% of patients with CF. In order to bring a more effective therapy to patients, the companies plan to develop multiple candidates and backups for each of the three components (1st generation correctors, next generation correctors, and potentiators) with the goal of identifying a potential triple combination.
In addition to our potentiator and corrector that are being tested in the clinic, a total of four additional compounds have the potential to reach clinical development in the CF program this year.
Triple combinations of CF compounds in the portfolio have consistently shown restoration of healthy activity levels in in vitro assays with human bronchial epithelial (HBE) cells of patients with the F508del mutation. These combinations result in chloride transport with an increase over Orkambi in HBE cells with the homozygous F508del mutation.
First generation corrector series
Dosing to humans of GLPG2222, the first 1st generation corrector in Galapagos' portfolio, started earlier this month. This achievement earns Galapagos a $10 million milestone payment in connection with the global collaboration agreement with AbbVie. Galapagos is conducting a randomized, double-blind, placebo-controlled study over a range of doses of GLPG2222 in healthy volunteers in Belgium and expects topline results in Q2 2016. Galapagos further announces the selection of preclinical candidate GLPG2851, an additional 1st generation corrector, aiming to initiate Phase 1 with this compound by the end of 2016.
Next-generation corrector series
Galapagos announced selection of the first next-generation corrector GLPG2665 in October 2015, expected to enter Phase 1 by mid-2016. Galapagos has announced selection of an additional next-generation corrector GLPG2737, expected to enter Phase 1 in healthy volunteers by Q4 2016. Galapagos and AbbVie are also developing an alternative series of next-generation correctors with different activity and expect to nominate candidates and additional compounds from that series later in 2016.
Galapagos has made regulatory filings for exploratory Phase 2 studies in CF patients for potentiator GLPG1837, and has received the first approvals to start from a number of countries. This early exploratory Phase 2 program with GLPG1837 will be conducted in Europe in G551D and S1251N mutation types. Additional potentiator GLPG2451 has entered preclinical development and is expected to move into Phase 1 trials in Q2 2016.
"Galapagos and AbbVie continue to make strong progress with our cystic fibrosis portfolio," said Onno van de Stolpe, CEO of Galapagos. "The CF franchise has really expanded into a full-sized portfolio. The resulting breadth, depth, and preclinical promise of this collection of modulators brings us again closer to our aim of bringing a superior triple combination therapy to CF patients."