Phase 2 Trial of Potential Oral Treatment for IPF Fully Enrolled, Galapagos Says
Galapagos NV announced that its Phase 2 PINTA trial, evaluating the safety and effectiveness of oral GLPG1205 in people with idiopathic pulmonary fibrosis (IPF), has completed patient recruitment ahead of schedule.
GLPG1205 is a small molecule designed to specifically block the activity of GPR84, a protein that drives chronic inflammation. Studies in mouse models of pulmonary fibrosis (PF) suggested that GLPG1205 could lessen lung damage, and results from a Phase 1 study (NCT01887106) in healthy volunteers confirmed that the therapy had a favorable safety and tolerability profile.
PINTA (NCT03725852) has enrolled more than 60 adults with IPF at 36 clinical sites across nine countries in Europe and the Middle East. Participants will be randomly assigned to either a placebo or 100 mg oral dose of GLPG1205, taken daily for 26 weeks.
“We are happy with the progress made in our PINTA trial, with recruitment completed ahead of schedule, and look forward to learning more about GLPG1205 in IPF,” Walid Abi-Saab, MD, chief medical officer at Galapagos NV, said in a press release.
The trial’s main goal (primary endpoint) will be to assess changes in forced vital capacity (FVC) from baseline (study start) until the end of the treatment period between those taking GLPG1205 or a placebo. FVC measures the total amount of air a person is able to exhale after a deep breath, and is often used as an indicator of lung function.
Secondary endpoints include a series of safety assessments (e.g., the frequency of common and serious events, including hospitalizations), changes in exercise capacity that will be assessed by the six-minute walk test, and participants’ quality of life as measured by the St. George’s Respiratory Questionnaire.
Trial investigators will also collect blood samples from patients to measure the levels of GLPG1205, and analyze its pharmacokinetic properties — essentially, how a therapy is absorbed, distributed, metabolized, and eliminated from the body.
In addition to PINTA, Galapagos has launched the global ISABELA program, which consists of two identically designed Phase 3 clinical trials, called ISABELA 1 (NCT03711162) and ISABELA 2 (NCT03733444). The program is expected to enroll over 1,500 people with IPF, ages 40 or older, all diagnosed within five years of being enrolled in either study.
Participants in these trials will be given one of two doses of GLPG1205 or a placebo for 52 weeks. Like in PINTA, the main goal of both ISABELA trials will be changes in FVC from baseline until the end of the treatment period.
The ISABELA program is being conducted at more than 200 locations worldwide, and is still recruiting eligible patients. Additional details can be found here.
“We are strongly committed to the rapid development of our IPF portfolio, including the worldwide Phase 3 ISABELA program that we are executing with our collaboration partner Gilead, to address this important unmet medical need,” Abi-Saab said.