Safety and efficacy of pamrevlumab (FG-3019)in patients with COVID-19 pneumonia: an open-label, randomized, parallel-arm phase 2 study

ABSTRACT

Background: Pamrevlumab (FG-3019), a recombinant monoclonal antibody binding connective tissue growth factor (CTGF), has shown antifibrotic effects in idiopathic pulmonary fibrosis. Inhibition of CTGF could ameliorate the pathobiological consequences of interstitial pneumonia induced by coronavirus SARS-CoV-2. Aims and objectives: To assess efficacy and safety of standard of care (SOC) plus intravenous pamrevlumab as compared to SOC alone in hospitalized patients with COVID-19 pneumonia. Method(s) Hospitalized patients with documented SARS-CoV-2 infection, evidence of interstitial pneumonia and respiratory distress requiring supplemental oxygenation were randomized in a 11 ratio to either SOC plus pamrevlumab, or SOC only. Pamrevlumab at the dose of 30 mg/kg was administered as IV infusion on Day 1, Day 7 and Day 14. All patients were followed up to 12 weeks. Primary efficacy endpoint was the proportion of patients alive and who never received mechanical ventilation at day 15. Result(s) A predefined interim analysis was performed in 42 patients randomized to SOC plus pamrevlumab (n=19) or SOC alone (n=23) between June 2020 and May 2021. No new side effects emerged as compared to previous trials. The proportion of patients alive and who never received mechanical ventilation at day 15 was numerically higher in the pamrevlumab group as compared to SOC group (84% and 74% respectively), however the difference was not significant (p=0.4, 95% CI-14% to 35%). Conclusion(s) Pamrevlumab did not provide significant benefit in a population of hospitalized patients with COVID19 pneumonia. No new safety signals emerged.