Galapagos has started the worldwide ISABELA Phase 3 program to evaluate the potential of GLPG1690 as a treatment for idiopathic pulmonary fibrosis (IPF), reporting that the first participant has already been treated.
GLPG1690 inhibits GPR84, a pro-inflammatory protein that promotes chronic inflammation in IPF. The U.S. Food and Drug Administration and the European Commission granted orphan drug designation to GLPG1690 as a treatment for IPF.
The global program consists of two identically designed trials, called ISABELA 1 (NCT03711162) and ISABELA 2 (NCT03733444). Together, they are expected to enroll a total of 1,500 patients, of 40 years of age or older, who have received an IPF diagnosis within 5 years of starting the trials.
More than 200 clinical sites worldwide will be involved in the program, including several centers located in the United States and Europe. During the studies, patients will be randomized to receive one of two doses of GLPG1690 or a placebo, in addition to their IPF standard of care treatment.
All patients will continue the assigned treatment until the last patient in each of the studies has completed 52 weeks of treatment. This means that some patients will be followed for substantially more time than the minimum 52 weeks. This particular trial design will allow researchers to have a broader assessment of less frequent treatment-related adverse events that otherwise could be difficult to detect with one-year standard clinical studies.
Researchers will evaluate the efficacy of GLPG1690 to improve patients’ lung function compared with the placebo, as determined by the rate of decline in forced vital capacity (FVC). They will also evaluate changes in disease progression, frequency of respiratory-related hospitalizations, quality of life, and mortality.
For more information about the trials and how to participate, visit the program webpage here.
The launch of the ISABELA program “demonstrates our commitment to the rapid advancement of our IPF franchise,” Walid Abi-Saab, MD, chief medical officer at Galapagos, said in a press release. “We are excited by the feedback received from participating sites and key opinion leaders, which underscores the need for novel treatments to address the remaining high unmet need in IPF.”
Previous results from the Phase 2 FLORA trial (NCT02738801) showed that a daily 600 mg dose of GLPG1690 resulted in an improvement in FVC at 12 weeks in IPF patients, and that the treatment was well-tolerated, with most side effects being mild to moderate.
At the end of October, Galapagos announced the start of another clinical study in IPF patients, the Phase 2 PINTA study (NCT03725852) that tests another GPR84 inhibitor called GLPG1205. Still recruiting, this study will assess the potential of the company’s new therapy in addition to standard treatments, such as Esbriet (pirfenidone) or Ofev (nintedanib), for 26 weeks in up to 60 IPF patients.