Novartis' (NVS) COVID-19 Study Fails to Meet Primary Endpoint

Novartis NVS and partner Incyte (NASDAQ:INCY) INCY announced that the late-stage study on ruxolitinib in COVID-19 patients was not successful.

The phase III RUXCOVID study is a multicenter, randomized, double-blind, placebo-controlled, 29-day study, evaluating the efficacy and safety of ruxolitinib plus standard of care (SoC) therapy compared to placebo plus SoC therapy in patients aged ≥12 years hospitalized with COVID-19 and not intubated or receiving ICU care prior to randomization. The study has enrolled 432 patients globally.

The study is sponsored by Novartis outside of the United States and by Incyte within the country.

The eligible patients were randomized 2:1 to receive oral ruxolitinib 5mg twice daily (BID) or oral-matching placebo for a total of 14 days. The initial data showed that there wasn’t any statistically significant reduction in the proportion of patients on ruxolitinib plus SoC therapy who experienced severe complications, including death, respiratory failure requiring mechanical ventilation or admission to the intensive care unit (ICU) by day 29, compared to SoC alone.

Hence, the study did not meet its primary endpoint of reducing the number of hospitalized COVID-19 patients who experienced severe complications.

The study also did not show clinically relevant benefit among secondary and exploratory endpoints, including mortality rate by day 29 and time to recovery (no longer infected, or ambulatory with no or minimal limitations).

Ruxolitinib, an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinase, is approved under the brand name, Jakavi, in Europe and other countries for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea and disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (MF), also known as chronic idiopathic MF, post-polycythemia vera MF or post-essential thrombocythemia MF. It is marketed in the United States by Incyte as Jakafi.

Novartis’ stock has lost 4.4% in the year so far against the industry’s growth of 1.1%.

Meanwhile, the company has collaborated with Molecular Partners to develop two DARPin therapies designed for potential use against COVID-19.

Earlier, Novartis entered into an exclusive worldwide license and collaboration agreement with Mesoblast (NASDAQ:MESO) MESO to develop, commercialize and manufacture remestemcel-L for the treatment of acute respiratory distress syndrome (ARDS), including that associated with COVID-19.

Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is racing against time to come up with treatments and vaccines to cure the contagion.

Last month, the FDA gave Emergency Use Authorization (EUA) to Regeneron’s REGN antibody cocktail, casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19.

Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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