- Adding a rheumatoid arthritis drug to antiviral treatment with Gilead's COVID-19 medicine Veklury helped hasten the recovery of patients hospitalized with coronavirus disease in a government-run clinical trial, Eli Lilly, the arthritis drug's maker, said Monday.
- But the apparent benefit of the drug combination, a one day reduction in the median time to recovery compared to treatment with Veklury alone, appears modest and fuller data from the study, such as on safety results or patient mortality, weren't made public.
- Lilly, however, plans to discuss with the Food and Drug Administration the possibility of an emergency authorization for its drug, called Olumiant, in treating COVID-19. Gilead's Veklury was cleared by the agency for emergency use in May and has been widely used to treat hospitalized COVID-19 patients since.
Researchers around the world have launched hundreds of studies of would-be coronavirus drugs, but so far their efforts have identified only two that proved beneficial in large, well-controlled clinical trials.
Gilead's Veklury was the first, shown by researchers at the National Institutes of Health to reduce recovery times among hospitalized COVID-19 patients by a median of four days compared to placebo. A study in the U.K., meanwhile, proved the steroid dexamethasone could lower the death rate among those sickest from coronavirus disease.
Most of the clinical evidence on coronavirus drugs collected to date has been inconclusive or negative, making the results for Olumiant notable even if the benefit is only incremental.
The study of Olumiant together with Veklury was also run by NIH researchers, who will publish the full results in a peer-reviewed medical journal in the "not-too-distant future," said Patrik Jonsson, head of Lilly's Bio-Medicines unit, in an interview.
Until then, however, many questions remain. Lilly did not disclose any safety findings in its statement on the trial, which will be crucial for assessing whether Olumiant could be used widely. The drug is already approved for rheumatoid arthritis, but at a lower dose than what researchers used for the COVID-19 trial, and comes with a warning for the risk of serious infections and blood clots.
The latter warning could be particularly important for determining how best to use Olumiant in COVID-19, which appears to cause extensive clotting throughout the body in severe cases.
Jonsson declined to offer any further details on safety, but noted the trial's monitoring board has been closely watching patients. Exposure to Olumiant in the study, he added, was much less than a rheumatoid arthritis patient would have, potentially changing the risk-benefit profile of the drug in COVID-19.
Lilly also disclosed little information about the degree of benefit observed in the study, noting only the relative improvement between study arms rather than the absolute values for each. No data on patient deaths was available, either.
"We are skeptical that a 1-day improvement in recovery will ever generate a significant mortality benefit," wrote Tyler Van Buren, an analyst at Piper Sandler, in a Monday note to clients.
Jonsson, however, noted that supportive care for COVID-19 patients has improved significantly since the first NIH study of Veklury, making it harder to show an additive benefit with Olumiant. "The bar was set extremely high," he said.
In addition to Olumiant, Lilly is also developing an antibody-based drug for COVID-19 prevention and treatment, as well as a treatment for the acute respiratory distress seen in severely ill COVID-19 patients.
Early testing found the antibody-based drug safe, according to Lilly, leading to the initiation of a large Phase 3 trial in August. Results from two NIH-led studies of the drug are expected in October or November, according to Cantor Fitzgerald analyst Louise Chen.
Regeneron, Vir Biotechnology, AbbVie and AstraZeneca are also working on antibody-based drugs for COVID-19, which some view as particularly important until a vaccine proven safe and effective, and is widely available.
The NIH, meanwhile, recently began testing on whether the immune drug interferon beta-1a could also prove beneficial when paired with Veklury.