Bexotegrast in patients with idiopathic pulmonary fibrosis has been shown to produce a significant improvement in forced vital capacity
In press release by the manufacturer, Pilant Therapeutics, interim data from a Phase IIa randomised, placebo-controlled trial, showed that bexotegrast at a daily dose of 320mg, achieved a statistically significant mean increase in forced vital capacity (FVC) after 12 weeks in patients with idiopathic pulmonary fibrosis.
Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease characterised by scarring of unknown cause, giving rise to dyspnoea and a non-productive cough. The data in the press release is derived from the INTEGRIS-IPF trial, a multi-national, randomised, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability and pharmacokinetics of once-daily bexotegrast in people with IPF. The study included four doses (40, 80, 160 and 320mg) and patients were randomised 3:1 (active vs placebo). Although the primary outcomes for INTEGRIS-IPF were not related to efficacy, exploratory efficacy analyses included changes in FVC and biomarkers such as PRO-C3, which is raised in patients with IPF and associated with disease progression.
Bexotegrast and IPF outcomes
A total of 21 patients were assigned to the 320mg dose and there was a mean FVC increase of 29.5ml compared to baseline at 12 weeks compared to a decrease of 110.7ml for those assigned to placebo (p < 0.05). Moreover, the mean increase was statistically superior to placebo at all timepoints. In addition, patients receiving 320mg saw a significant reduction in PRO-C3 levels at both week 4 and 12 (p <0.01) compared to placebo.
The press release adds that 24-week data for patients treated with bexotegrast should be available in the second quarter of 2023.