Ziritaxestat not found effective in patients with idiopathic pulmonary fibrosis: JAMA

A new study by Toby Maher and team showed that patients with idiopathic pulmonary fibrosis (IPF) getting standard of care medication with pirfenidone or nintedanib or those not receiving standard of care treatment did not experience any differences in clinical outcomes between ziritaxestat and placebo. The findings of this study were published in the Journal of American Medical Association.

The 26 nations that made up the continents of Africa, Asia-Pacific, Europe, Latin America, the Middle East, and North America participated in the phase 3 randomized clinical trials known as ISABELA 1 and ISABELA 2. 1306 IPF patients in total were randomly assigned. Both trials saw the start of enrollment in November 2018, and follow-up was finished early owing to study terminations for ISABELA 1 and ISABELA 2 on April 12, 2021, and March 30, 2021, respectively. In addition to the regional standard of therapy (pirfenidone, nintedanib, or neither), patients were randomized 1:1:1 to receive 600 mg of oral ziritaxestat, 200 mg of ziritaxestat, or a placebo once daily for at least 52 weeks.

The key findings of this study were;

1. 525 patients were randomly assigned to ISABELA 1 and 781 patients to ISABELA 2 at the time the trial was terminated.

2. An independent data and safety monitoring committee decided that the benefit to risk profile of ziritaxestat no longer supported the continuation of the studies, hence they were stopped early.

3. In either research, ziritaxestat did not enhance the yearly rate of FVC decrease in comparison to placebo.