Promising new agent as treatment for pulmonary fibrosis

With or without present background therapy, BMS-986278 was deemed more effective than placebo in patients with progressive pulmonary fibrosis (PPF). In a phase 2 trial, the study drug reduced the percentage predicted forced vital capacity ppFVC decline.

“Earlier this year at American Thoracic Society conference 2023, we presented the results of a phase 2 study in idiopathic pulmonary fibrosis which showed that BMS-986278 was effective in reducing the rate of decline of ppFVC at 26 weeks [1].Now, I’m turning the focus on PPF,” Prof. Tamara Corte (University of Sydney, Australia) started her presentation on the parallel cohort of the phase 2 randomised study (NCT04308681) [2]. The PPF cohort consisted of 125 patients, all were ≥21 years old and met the criteria of progression (mean age 67.9–71.4 years; 48.8–57.5% women). In 3 study arms, the treatment consisted of either placebo or the LPA1 antagonist BMS-986278 twice daily at 30 mg or 60 mg. The primary endpoint of change in ppFVC was evaluated at week 26. Background antifibrotics and immunosuppressants were permitted.

Looking at the rates of change in ppFVC that included all data, a relative reduction of 74% (-4.3 vs -1.1) was detected for the comparison between the placebo and the 60 mg arm. The difference for participants receiving placebo or 30 mg of the study drug was 1.6 (-4.3 vs -2.7), which indicates the presence of a dose-related response. ”The placebo group had a decline of 127 mL at 26 weeks of FVC compared with a decline of around 40 mL for the 60 mg arm,” Prof. Corte disclosed the observed absolute change from baseline in FVC. When stratifying according to the presence or absence of background antifibrotics, the relative reduction in change of ppFVC was 85% for the comparison of placebo versus 60 mg study drug. The results for the distinction between patients with or without UIP pattern yielded 63%.

Treatment-related adverse events ≥ grade 1 occurred in 78% (placebo), 82.5% (30 mg), and 66.7% (60 mg) of the participants. “Gastrointestinal side effects were low, and that is particularly interesting, in fact, as these patients were allowed to be on background antifibrotic therapy,” Prof. Corte noted. Among the 3 arms, discontinuation of therapy due to adverse events was observed in 14.6% (placebo), 2.5% (30 mg), and 0% (60 mg) of the participants.

“These findings, together with the findings from the idiopathic pulmonary fibrosis parallel cohort, give us confidence in this study going forward into phase 3 clinical trials,” Prof. Corte concluded.

1. Corte TJ, et al. Session B17, ATS International Conference 2023, 19–24 May, Washington DC, USA.
2. Corte T. RCT Abstract - BMS-986278 for progressive pulmonary fibrosis (PPF): results from a phase 2 randomised controlled trial. Abstract 800, ERS 2023 International Congress, 9–13 September, Milan, Italy.

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Posted on 29 October, 202329 October, 2023