Vicore's ASPIRE trial of buloxibutid clears futility check, stays on track for 2027

Vicore Pharma Holding AB said on October 22, 2026 that the independent Data Monitoring Committee overseeing its Phase 2b ASPIRE trial of buloxibutid in idiopathic pulmonary fibrosis recommended that the trial continue without modification after reviewing a pre-planned futility analysis¹. The committee also conducted its routine safety review and raised no concerns after looking at all available data in parallel with the futility check¹.

The trial remains on track to report 52-week topline results in mid-2027¹.

The futility check was built to determine whether the trial should stop early, and since the pre-set criteria were not met, the committee told Vicore to proceed as designed¹. According to the company, an outside statistician ran the analysis and the committee reviewed it using data from roughly the first 100 patients who had either finished 52 weeks of dosing or dropped out, about 27% of those enrolled¹. The review looked at the change in forced vital capacity from baseline at week 52 for the 100 mg twice-daily dose against placebo, applying a conditional power method that would have flagged futility if power fell below 20%¹.

Vicore said it has not seen any of the underlying numbers. The company remains blinded to the trial data, and details like treatment effect size or the conditional power figures were kept from the company to protect the trial's integrity.¹

ASPIRE is a global, randomized, placebo-controlled study testing two doses of buloxibutid, 50 mg or 100 mg taken orally twice daily, against placebo¹. Enrollment finished in April 2026 with 378 patients randomized across more than 100 sites in 14 countries, including the United States.¹ CEO Ahmed Mousa said the company's cash runway extends into the second half of 2028, past the planned readout.¹