Eli Lilly’s and Incyte’s Olumiant Fails in Late-Stage COVID-19 Trial

Eli Lilly’s and Incyte’s Janus kinase (JAK) inhibitor Olumiant (baricitinib) proved unable to significantly reduce progression to noninvasive ventilation for COVID-19 patients in a phase 3 trial, though the drug still managed to significantly reduce the risk of death.

The companies announced Thursday that the phase 3 study, which evaluated a once-daily 4mg dose of Olumiant plus standard of care in hospitalized coronavirus patients (including corticosteroids and remdesivir) didn’t meet its primary endpoint of reducing progression to noninvasive ventilation, including high flow oxygen or invasive mechanical ventilation.

Patients given the JAK inhibitor were only 2.7 percent less likely than those who received standard of care to progress to ventilation or death, a finding that was not statistically significant, the pair said. The drug did, however, meaningfully reduce the risk of death.

“While [the trial] did not hit the primary endpoint based on stages of disease progression, the data show that [Olumiant] meaningfully reduced the risk of mortality above and beyond the recommended standard of care, without additional safety risks,” said the trial’s co-primary investigator E. Wesley Ely.

Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines, said that despite failing in its main goal, the trial demonstrated “the largest effect reported to date” for reducing mortality in the patient population — patients who did not require supplemental oxygen, patients who did require it and patients who needed high-flow oxygen/noninvasive ventilation. The trial, which enrolled 1,525 patients, required participants to have at least one marker of inflammation, which indicates a risk of disease progression.

“The demonstration of a potential effect on mortality is a clinically important finding. This effect on mortality was seen with or without corticosteroids and/or remdesivir at the time of enrollment,” said Vincent Marconi, a co-principal investigator on the trial.

Lilly said it plans to publish detailed study results in a peer-reviewed journal “in the coming months.”

Earlier this week, Olumiant suffered another setback when it saw its FDA review for treating moderate-to-severe atopic dermatitis pushed back three months. Eli Lilly and Incyte said that the agency delayed its review action date to assess additional data Lilly provided in response to requests for more information. The agency appears to be looking more closely at JAK inhibitors, having also delayed reviews for other drugs in the class (DID, April 8).

Olumiant received Emergency Use Authorization (EUA) from the FDA in November 2020 for use alongside remdesivir in treating COVID-19 in patients age two and up that must be put on supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation (DID, Nov. 23, 2020). — James Miessler