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6th February 2023
In press release by the manufacturer, Pilant Therapeutics, results from a phase 2a placebo-controlled trial, showed that bexotegrast at a daily dose of 320 mg, achieved a statistically significant mean increase in forced vital capacity (FVC) from baseline up to week 12 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 comes 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 idiopathic pulmonary fibrosis. The study included four doses (40, 80, 160 and 320 mg) 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 320 mg 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 320 mg 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.