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Friday, November 6, 2020

Novartis comes up empty in study of canakinumab in COVID-19

  • Novartis' (NYSE:NVS) CAN-COVID trial evaluating the efficacy and safety of canakinumab in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome failed to meet endpoints.
  • The ongoing trial did not achieve its primary endpoint showing canakinumab plus standard of care (SoC) failed to demonstrate a significantly greater chance of survival for patients without the need for invasive mechanical ventilation, compared with placebo plus SoC up to Day 29.
  • Survival without the need for mechanical ventilation was 88.8% for canakinumab plus SoC vs 85.7% for placebo plus SoC (P=0.29).
  • Key secondary endpoint of reducing the COVID-19-related death rate during the 4-week period after treatment was also missed.
  • COVID-19-related mortality was 4.9% for canakinumab plus SoC vs 7.2% for placebo plus SoC (P=0.33).
  • Both the primary and key secondary endpoints trended in favor of canakinumab but did not reach statistical significance.
  • The safety profiles of canakinumab plus SoC and placebo plus SoC were comparable.
  • No new safety signals for canakinumab were identified.
  • To further support global pandemic response, in October NVS collaborated with Switzerland-based Molecular Partners to develop two DARPin therapies designed for potential use against COVID-19.
  • In addition, a Phase III trial for ruxolitinib in COVID-19 is ongoing, with preliminary results expected by year end.
  • https://seekingalpha.com/news/3632966-novartis-comes-up-empty-in-study-of-canakinumab-in-covidminus-19

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