Expected to begin in the second half of 2018, the PINTA trial will evaluate the safety and effectiveness of this investigational therapy at several clinical sites in Europe, North Africa, and the Middle East.
GLPG1205 is a small molecule designed to selectively inhibit GPR84, a pro-inflammatory protein known to be involved in chronic, low-grade inflammatory diseases, including IPF.
Results from preclinical studies have demonstrated that GLPG1205 could reduce IPF symptoms in animal models of the disease. Data collected from a Phase 1 trial (NCT01887106) conducted in healthy volunteers showed that GLPG1205 is generally safe and well-tolerated.
Despite its demonstrated potential, GLPG1205 failed to show therapeutic activity in patients with ulcerative colitis — an inflammatory disease that affects the bowel — in the Phase 2 ORIGIN trial (NCT02337608).
“GLPG1205 has shown signs of good activity in relevant animal models, and GPR84 has already been validated as a mechanism in combination with nintedanib [Ofev] in IPF,” Piet Wigerinck, PhD, chief scientific officer of Galapagos, said in a press release. “We have a well-designed trial with PINTA for ‘1205 that we anticipate will give us new insights into the potential value of GPR84 inhibition as a mechanism to treat this highly fatal disease.”
PINTA is a randomized, double-blind, placebo-controlled trial that will evaluate the activity of GLPG1205 in about 60 patients with a confirmed IPF diagnosis. Participants will receive either a once-daily, 100 mg oral dose of GLPG1205 or a placebo for 26 weeks. Patients will be allowed to continue their standard treatment regimen as background therapy.
The main goal of the trial is to assess the potential of the new therapy to improve lung function capacity compared with placebo, as determined by forced vital capacity (FVC). In addition, researchers will also evaluate changes in functional exercise capacity, the treatment’s safety profile and overall stability in the body, as well as its impact on patients’ quality of life.
Galapagos is currently developing two other new therapy candidates, GLPG3499 and GLPG1690, which have different mechanisms of action designed to target IPF. GLPG3499 is currently in preclinical development, whereas GLPG1690 is expected to enter the worldwide ISABELA Phase 3 program during the second half of 2018.
In September 2016, GLPG1690 received orphan drug designation for IPF treatment by the European Commission.
In the Phase 2 FLORA trial (NCT02738801), a once-daily 600 mg dose of GLPG1690 given for 12 weeks showed potential to prevent lung function decline in IPF patients. The therapy was also found to be safe and well-tolerated by patients.
Galapagos has announced that the ISABELA program will consist of two identically designed trials, ISABELA 1 and ISABELA 2, which are anticipated to enroll 1,500 IPF patients.