The analysis was based on efficacy data from about the first 100 randomized patients who had completed 52 weeks of treatment or left the trial, around 27% of those enrolled. It assessed the primary endpoint, change from baseline in forced vital capacity (FVC) at week 52, for the high dose of buloxibutid (100 mg twice daily) against placebo. The trial would have been considered for stopping if the probability of success fell below a pre-set threshold. Vicore remains blinded to the data and received no quantitative results. In a parallel safety review, the committee raised no concerns.

ASPIRE completed enrollment in April 2026 with 378 patients across more than 100 sites in 14 countries, including the US. Participants receive one of two doses of buloxibutid or placebo, either alone or on top of standard antifibrotic treatment. Buloxibutid is an oral angiotensin II type 2 receptor agonist with Orphan Drug and Fast Track designations from the FDA. Vicore says its cash runway extends into the second half of 2028, beyond the readout.

“Passing this futility analysis is an important milestone that allows ASPIRE to continue as designed,” says Ahmed Mousa, CEO of Vicore Pharma.