Eli Lilly and Incyte shared more details, including mortality data, from the ongoing ACTT 2 trial evaluating their JAK1/JAK2 inhibitor Olumiant (baricitinib) in combination with Gilead Sciences’ Veklury (remdesivir) in patients with COVID-19 infection. The companies said last month that the study, which was launched in May by the US National Institute of Allergy and Infectious Diseases (NIAID), had achieved its primary endpoint by significantly reducing the time to recovery compared to Veklury alone among hospitalised patients.
Ilya Yuffa, president of Lilly Bio-Medicines, said the company is “excited” by these latest results, and that it is currently in discussions with the FDA regarding the potential to make Olumiant available under an emergency-use authorization to hospitalized patients “as quickly as possible.”
The 1034-patient ACTT 2 trial is testing a 4-mg oral dose of Olumiant plus intravenous Veklury, versus Veklury alone, in hospitalized patients infected with SARS-CoV-2 who show signs of lung involvement, such as abnormal chest x-rays, or the need for supplemental oxygen or mechanical ventilation. The primary endpoint was time to 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.
Greater benefit in patients requiring oxygen
On Thursday, Eli Lilly and Incyte said Olumiant had a “significant effect” on recovery time, noting that in the overall patient population treated with the combination, median recovery times shortened from eight to seven days compared to Veklury alone, reflecting a 12.5% improvement. Further, the odds of improvement in clinical status at day 15, a secondary endpoint that was measured using an ordinal scale ranging from full recovery to death, were 30% greater among patients in the Olumiant group.
Meanwhile, the companies reported that “a numerical decrease in death (35%) through day 29 was observed in patients treated with Olumiant plus Veklury, compared to Veklury [alone], in the overall population,” noting that the mortality rates were 5.1% and 7.8% (P=0.09), respectively. They said the reduction in mortality was “more pronounced for patients receiving oxygen, as mortality at day 29 was 60% lower and 43% lower for the OS5 and OS6 subgroups, respectively.” The companies stated that the NIAID authors are in the process of conducting a full analysis and a peer-reviewed manuscript will be made available soon.
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.