Zinpentraxin alfa comparable to placebo in idiopathic pulmonary fibrosis

Among patients with idiopathic pulmonary fibrosis, lung function decline was comparable between 52-week zinpentraxin alfa treatment and placebo, according to results published in American Journal of Respiratory and Critical Care Medicine.

“Although well tolerated, no clinical benefit of zinpentraxin alfa over placebo was observed in the STARSCAPE trial in patients with IPF,” Luca Richeldi, MD, PhD, head of the division of respiratory disease at Agostino Gemelli University Hospital and professor of respiratory medicine at Catholic University of the Sacred Heart in Rome, and colleagues wrote.

Idiopathic pulmonary fibrosis

In a 52-week, double-blind, placebo-controlled, multicenter, pivotal phase 3 trial (STARSCAPE), Richeldi and colleagues assessed 660 adults (mean age, 70.7 years; 80.5% men) with IPF to evaluate the impact of 10 mg/kg of zinpentraxin alfa every 4 weeks for 52 weeks on FVC vs. placebo.

Researchers also compared percent-predicted FVC, 6-minute walking distance and adverse events at week 52 between the two groups. According to researchers, patients with IPF receiving this treatment for 28 weeks previously demonstrated clinical benefit in a phase 2 trial.

In the phase 3 study population, 330 patients (mean age, 70.8 years; 81.8% men) received zinpentraxin alfa, and the remaining 330 patients (mean age, 70.5%; 79.1% men) received placebo.

The drug had no treatment benefit vs. placebo in a pre-specified futility analysis, leading to early termination of the trial and only 106 patients completing the study (mean treatment exposure, 26.7 weeks), researchers wrote.

March 6, 2024