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Summer 2020 - Vaccines

Novartis Initiates Phase III Trial of Ilaris to Treat COVID-19 Patients with Pneumonia

The primary objective of the study is to demonstrate the benefit of canakinumab in combination with standard of care (SoC) in increasing the chance of survival without the need for invasive mechanical ventilation among patients with COVID-19 pneumonia.

Novartis has initiated a Phase III clinical trial to examine the efficacy of utilizing canakinumab (Ilaris), an interleukin (IL)-1β blocker, to treat a type of severe immune overreaction called cytokine release syndrome (CRS) in people with COVID-19 pneumonia. The primary objective of the study is to demonstrate the benefit of canakinumab in combination with standard of care (SoC) in increasing the chance of survival without the need for invasive mechanical ventilation among patients with COVID-19 pneumonia. Results are anticipated late summer 2020.

The study builds on early evidence from lab tests of COVID-19 patients who showed elevated IL-1β levels, among other cytokines. For the CAN-COVID trial, Novartis aims to rapidly enroll 450 patients at multiple medical centers across France, Germany, Italy, Spain, the United Kingdom and the United States, and randomize them to receive either canakinumab or placebo on top of SoC.

References

Novartis to Begin Phase III Clinical Trial of Autoimmune Disease Drug in COVID-19 Patients with Pneumonia. Novartis press release, May 2, 2020. Accessed at www.hospimedica.com/covid-19/articles/294782125/novartis-to-begin-phase-iii-clinical-trial-of-autoimmune-disease-drug-incovid-19-patients-with-pneumonia.html.

BSTQ Staff
BioSupply Trends Quarterly [BSTQ] is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace. With timely and critical information, each themed issue covers topics ranging from product breakthroughs, industry insights and innovations, up-to-the-minute news on the latest clinical trials, accessibility, and service and safety concerns.