Novartis and Incyte Launch Second Phase III Clinical Trial of Jakafi (ruxolitinib) in COVID-19 Patients Requiring Mechanical Ventilation for ARDS

Compiled by S.Li

Novartis and Incyte Announce Initiation of Second Phase III Clinical Trial of JAK Inhibitor Jakafi (ruxolitinib) for COVID-19, Evaluating the Safety and Efficacy of Jakafi Combined with Standard of Care (SoC) in COVID-19 Patients with Acute Respiratory Distress Syndrome (ARDS) Requiring Mechanical Ventilation

As a therapy for severe respiratory immune responses, Jakafi has long been deployed in the fight against COVID-19. In early April, Novartis and Incyte launched Ruxcovid, a global, randomized, double-blind, placebo-controlled Phase III clinical trial, primarily to evaluate the efficacy and safety of Jakafi combined with standard of care (SoC) in treating cytokine storm in patients with COVID-19. Cytokine storm is a severe hyperimmune response that can lead to life-threatening respiratory complications in patients with COVID-19.

Jakafi is an innovative oral Janus kinase 1 and 2 (JAK1/JAK2) inhibitor that was approved by the FDA in 2011 for the treatment of myelofibrosis, and subsequently received approval for two additional indications: polycythemia vera and acute graft-versus-host disease (GVHD). Based on preclinical evidence, preliminary reports from independent studies, and the safety profile demonstrated by Jakafi in the treatment of conditions such as GVHD, Novartis and Incyte believe that Jakafi has the potential to enable faster recovery in COVID-19 patients and reduce the need for intensive care and mechanical ventilation.

In addition, Roche’s IL-6 inhibitor Actemra and Sanofi/Regeneron’s IL-6 inhibitor Kevzara are also being evaluated in Phase III clinical trials for the treatment of patients with severe COVID-19.

In light of the urgency of the COVID-19 pandemic, Incyte also launched an Emergency Expanded Access Program (EAP) in the United States, which allows eligible patients experiencing severe COVID-19-related cytokine storm to receive Jakafi for this indication while research is ongoing.

References:

1、Novartis, Incyte will take Jakafi into 2nd trial for COVID-19 patients on ventilators

2、Incyte Reports 2020 First Quarter Financial Results and Provides Updates on Key Clinical Programs