Galapagos has started dosing the first healthy volunteer with a combination of novel corrector GLPG2222 and novel potentiator GLPG2451 for cystic fibrosis in a Phase 1 study.
After completion of the dosing of GLPG2451 as a monotherapy, in the new cohorts the safety, tolerability and PK of 14 days co-administration of GLPG2451 and GLPG2222 is being evaluated.
Galapagos and AbbVie have a portfolio of candidates addressing three complementary components for a potential combination therapy. In the present study, potentiator GLPG2451 and C1 corrector GLPG2222 are evaluated as potential components of this triple combination, Galapagos explained in its press release.
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 an increase in chloride transport compared to Orkambi in HBE cells with the homozygous F508del mutation.
“We are pleased to have initiated our first dual combo Phase 1 study with our potentiator and C1 corrector for cystic fibrosis,” said Dr Piet Wigerinck, CSO of Galapagos. “This step brings us closer to our goal of initiating a patient evaluation of a triple combination therapy by mid-2017.”
Financial results for 2016
Galapagos has reported net profit of €54 million whch is increase compared to a net loss of €118.4 million in 2015.
Bart Filius, Galapagos’s CFO, commented: “Galapagos had an extraordinary year with strong financial results. We ended 2016 with the largest cash balance in our history, and with cash burn well under control. Our cash balance now exceeds the cumulative investments made by all investors in Galapagos since its inception in 1999.”
Filius said that the company plans to continue to ramp up its late stage development activities this year, as it plans to increase investments in filgotinib and CF and initiate more clinical studies with proprietary programs.