Eli Lilly has reported new data for its COVID-19 antibody and announced that is has submitted an emergency use authorisation for the drug to the US Food and Drug Administration (FDA).
The new data, from an interim analysis of the BLAZE-1 clinical trial, showed that a combination therapy of two SARS-CoV-2 neutralising antibodies, was able to reduce viral load as well as symptoms and COVID-19-related hospitalisation and accident and emergency visits.
The phase 2 study evaluated LY-CoV555 and LY-CoV016, which bind to different regions of the SARS-CoV-2 spike protein, for the treatment of symptomatic COVID-19 in an outpatient setting.
The combination therapy was well tolerated within the study, with no drug-related serious adverse events, with treatment emergent adverse events comparable to placebo for both LY-CoV555 monotherapy and combination therapy.
Lilly is seeking an initial emergency approval in the US for the LY-CoV555 monotherapy in high-risk patients who have recently been diagnosed with mild-to-moderate COVID-19.
Following that, Lilly expects to submit another emergency approval request with the FDA for the combination therapy in November after additional safety data is available and sufficient supplies of the drugs are manufactured.
Lilly is continuing to study its antibodies across a range of possible indications for the treatment of COVID-19. This includes planned and ongoing studies of the combination therapy given at lower doses and with alternative delivery options.
Additional ongoing trials include a phase 3 study of LY-CoV555 monotherapy for the prevention of COVID-19 in residents and staff working at care homes, as well as phase 2/3 studies in ambulatory or hospitalised COVID-19 patients.
“We believe the data generated to date provides sufficient evidence that both monotherapy and combination therapy may be effective to treat COVID-19 in patients with a high risk for serious outcomes. Lilly is diligently working with regulators around the world to make these treatments available,” said Daniel Skovronsky, chief scientific officer at Lilly and president of Lilly Research Laboratories.
In addition to its studies of the COVID-19 targeting antibodies, Lilly is also undertaking clinical development of its JAK inhibitor Olumiant (baricitinib) in combination with Gilead’s remdesivir in patients with hospitalised COVID-19.
In the ACTT-2 trial, sponsored by the US National Institute of Allergy and Infectious Disease (NIAID), the combination treatment hit the primary endpoint of a reduction in recovery time.
The study investigators defined recovery as the participant being well enough for hospital discharge – meaning the participant did not require supplemental oxygen or ongoing medical care in hospital.
The combination treatment also met the secondary endpoint of comparing patient outcomes at day 15, using an ordinal eight-point scale ranging from fully recovered to death.
Lilly is also seeking an emergency use authorisation for Olumiant in combination with remdesivir with the FDA for the treatment of patients hospitalised with COVID-19.