An investigational drug, BMS-986278, reduced ppFVC decline in progressive pulmonary fibrosis, regardless of background therapy.
BMS-986278 reduced percent predicted (pp) FVC decline in patients with progressive pulmonary fibrosis (PPF). Results were similar between groups with or without background therapy.
The lysophosphatidic acid receptor1 antagonist BMS-986278 was under investigation in a phase 2 parallel-group randomized trial. Positive results for the treatment of idiopathic pulmonary fibrosis have been shown earlier this year. At the 2023 ERS International Congress, Tamera Corte, BsC(Med), MBBS, PhD, revealed the findings for the patients with PPF.
The PPF cohort included 125 patients, all aged 21 years or older and meeting the criteria of progression. In three study arms, the treatment consisted of either placebo or BMS-986278 twice daily at 30 mg or 60 mg. The primary endpoint of change in ppFVC was evaluated at week 26. Of note, background antifibrotics and immunosuppressants were permitted.
The mean age ranged between 67.9 and 71.4 and 48.8% to 57.5% were women. The mean ppFVC was around 66%, over 40% had background therapy, and a pattern of usual interstitial pneumonia (UIP) was present in 50% to 55%.
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 between placebo and 30 mg of the study drug was 1.6 (−4.3 vs −2.7). Thus, a dose-related response was present. “The placebo group had a fall of 127 mL at 26 weeks of FVC compared with the 60-mg arm that had a fall of around 40 mL,” Dr. Corte commented on 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 (placebo vs 60 mg) was 85%. The respective results for the distinction between patients with or without UIP pattern yielded 63%.
Treatment-related adverse events of one or more occurred in 78% (placebo), 82.5% (30 mg) and 66.7% (60 mg). “Gastrointestinal side effects were low, and that’s particularly interesting I guess, in fact, that these patients were allowed to be on background antifibrotic therapy,” Dr. Corte said. Among the three arms, discontinuation of therapy due to these adverse events were 14.6% (placebo), 2.5% (30 mg) and 0% (60 mg).
“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,” Dr. Corte concluded.
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