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Novartis, Incyte: RUXCOVID Study Of Ruxolitinib In COVID-19 Patients Did Not Meet Primary Endpoint

Novartis (NVS) and Incyte Corp. (INCY) announced Monday that RUXCOVID Phase III study of ruxolitinib for hospitalized patients with COVID-19 failed to meet primary endpoint.

Ruxolitinib is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases.

The Phase III RUXCOVID study evaluated ruxolitinib on top of standard of care or SoC therapy compared to SoC treatment alone in patients with COVID-19.

In the trial, initial data show there was no statistically significant reduction in the number of hospitalized COVID-19 patients on ruxolitinib plus SoC therapy who experienced severe complications including death, mechanical ventilation or ICU care.

The proportion of patients who died, or required mechanical ventilation due to respiratory failure or ICU care by Day 29, the primary endpoint, was 12.0% for ruxolitinib plus SoC compared to 11.8% for placebo plus SoC.

The trial also did not show clinically relevant benefit among secondary and exploratory endpoints including mortality rate, and time to recovery.

Ruxolitinib was generally well-tolerated, and a comprehensive analysis including safety data is ongoing.

The companies noted that the results of RUXCOVID do not affect any ongoing trials for ruxolitinib in non-COVID-19 diseases.

RUXCOVID is sponsored by Incyte in the US and Novartis outside of the US. Novartis licensed ruxolitinib from Incyte for development and commercialization outside the US. It is marked outside the US by Novartis as Jakavi, and in the US by Incyte as Jakafi.

The RUXCOVID study is complete. The data will be further analyzed to determine any potential impact on other studies of ruxolitinib in patients with COVID-19, and will be submitted for publication.

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