Swedish pharma company Vicore announced the results of its phase 2a AIR trial for idiopathic pulmonary fibrosis (IPF) treatment, buloxibutid, at the American Thoracic Society (ATS) International Congress. According to the details shared, the drug has been successful in improving lung functions.
In the trial, patients were administered a 100-mg dose of the drug twice daily in oral form.
The trial successfully reached its primary endpoint when buloxibutid, which acts as an angiotensin II type 2 receptor agonist, raised the forced vital capacity (FVC)—a measure of how much air can be exhaled—by over 400ml compared to untreated patients. Additionally, after being enrolled in the trial for 36 weeks, patients who received the drug showed an average increase of over 215ml in capacity.
This improvement above the baseline was observed across all subgroups in the trial, including gender, geography, and radiological pattern.
The clinical impact of the treatment was measured across two biological markers: levels of collagenase MMP-13 and levels of the profibrotic cytokine TGFβ1. The former has the potential to degrade fibrosis, while the latter is known for driving processes involved in IPF. In the trial, researchers observed an increase in the level of MMP-13 and a drop in the levels of TGFβ1.
In terms of the safety profile, the drug was observed to be safe and well-tolerated. No serious adverse events were reported, and the treatment had good gastrointestinal tolerability according to the company. At both 12 and 24-week intervals, investigators conducted a risk and benefit evaluation to check whether any patient needed to be switched to the standard-of-care. Outcomes from these evaluations revealed that 97% of the patients were responding positively to the treatment.
“The results of the trial exceeded everyone’s expectations,” Vicore CEO Ahmed Mousa said. He added that given the results in terms of FVC improvement and biomarker data, it would not be incorrect to say that buloxibutid has disease-modifying potential.
Given these findings, Vicore has decided to proceed with a phase 2b trial called ASPIRE, which will be a double-blind, placebo-controlled, randomized, parallel-group multicenter study. The purpose of this trial is to assess changes in forced vital capacity caused by buloxibutid at 52 weeks.
IPF is a rare, progressive, lethal fibrotic lung disease with a life expectancy of 3-5 years after diagnosis. The disease occurs primarily in middle-aged and elderly adults, and currently, there are only two anti-fibrotic therapies on the market, both limited in terms of efficacy and tolerability.
