Eli Lilly and Incyte reported Monday that the JAK1/JAK2 inhibitor Olumiant (baricitinib) in combination with Gilead Sciences' Veklury (remdesivir) met the primary endpoint of the ACTT 2 study by significantly reducing the time to recovery compared to Veklury alone in hospitalised patients with COVID-19. Eli Lilly said that based on the results, it plans to discuss the potential for emergency-use authorisation (EUA) of Olumiant with the FDA, as well as similar measures with other regulatory bodies.
The study, which was launched in May by the US National Institute of Allergy and Infectious Diseases (NIAID), included 1034 patients and evaluated a 4-mg oral dose of Olumiant plus intravenous Veklury, versus Veklury alone, in hospitalised patients infected with SARS-CoV-2 who show signs of lung involvement, such as the need for supplemental oxygen or mechanical ventilation, or having abnormal chest X-rays. The primary endpoint was time to recovery, with recovery defined as the patient no longer being hospitalised at day 29, or being well enough for discharge because they either do not need supplemental oxygen anymore or ongoing medical care in hospital.
Initial results demonstrated that adding Olumiant to Veklury cut the median time to recovery by roughly one day, compared to Veklury alone, an improvement that was statistically significant. Previously announced results from the NIAID-led ACTT trial had shown that Veklury led to a 31% faster time to recovery in hospitalised patients with advanced COVID-19, shaving four days off recovery times when compared to placebo. Gilead's antiviral drug was awarded an EUA shortly after those findings were made public.
Meanwhile, Eli Lilly and Incyte noted that ACTT 2 also met a key secondary endpoint comparing patient outcomes at day 15 using an ordinal eight-point scale ranging from fully recovered to death. They noted that more analyses are under way, including a closer look at mortality and safety data.
"These data allow us to better understand Olumiant's role in potentially improving outcomes for hospitalised COVID-19 patients, and we look forward to continuing this research alongside our other initiatives to combat COVID-19," remarked Daniel Skovronsky, chief scientific officer at Eli Lilly. The drugmaker indicated that it plans to assess any impact of the ACTT 2 results on the placebo-controlled Phase III COV-BARRIER trial that it launched in June to test Olumiant against background therapy in hospitalised adults with COVID-19 in the US, Europe, Asia and Latin America. Participants in this ongoing study have at least one elevated marker of inflammation, but do not need invasive mechanical ventilation at study entry.
The 2-mg dose of Olumiant is already approved in the US and several other countries as a treatment for adults with moderately-to-severely active rheumatoid arthritis. If authorised for use in COVID-19, Eli Lilly said it will propose that Olumiant be available through commercial channels, but that it will continue to create adequate supply for rheumatoid arthritis patients and also ensure the drug remains available in countries where it is approved.
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