Eli Lilly and Co. is ending a clinical trial for an antibody drug for hospitalized COVID-19 patients after data suggested that the treatment is unlikely to help people recover from the advanced stage of the disease.
The Indianapolis-based pharmaceutical company announced the decision regarding the clinical trial, run by the National Institute of Allergy and Infectious Diseases, on Monday. The study, which Lilly halted patient enrollment for earlier this month due to safety concerns, evaluated the efficacy of using the drug, called bamlanivimab, in hospitalized COVID-19 patients.
Lilly said data revealed insufficient evidence that bamlanivimab improved clinical outcomes when added to other treatments for hospitalized COVID-19 patients.
Other bamlanivimab studies on recently diagnosed and mild to moderate patients are ongoing, the company said.
On Tuesday, Lilly CEO and Chairman Dave Ricks acknowledged that the company missed analysts’ third quarter projections, citing less than expected earnings.
In a conference call Tuesday, Ricks said Lilly’s worldwide revenues rose 5% to $5.74 billion. Key growth products such as diabetes drug Trulicity and Taltz, a treatment for autoimmune disease, accounted for half of the revenue in the third quarter.
However, net income was down 4% to $1.21 billion, or $1.33 earnings per share, during the quarter, compared to $1.25 billion, $1.37 earnings per share, for the same period last year.
Ricks said the less-than-expected earnings during the quarter were partially due to lower realized prices driven by increased rebates and changes to estimates for rebates and discounts, primarily affecting the diabetes drug Trulicity.
The company also saw increased operating expenses related to investments in marketing and in developing potential COVID-19 therapies. Operating expenses rose 9% to $3.03 billion.
Lilly invested $125 million during the quarter to develop and rapidly advance potential new COVID-19 antibody therapies for clinical testing, Ricks said. The company anticipates its full-year COVID-19 research and development expense to be about $400 million.
“I’m encouraged by our company’s effort to develop potential new treatments for COVID-19 and working at unprecedented speed,” Ricks told investors and analysts on the call.
Lilly still anticipates 2020 revenue between $23.7 billion and $24.2 billion, though the company said achieving the high end of the range would require the inclusion of moderate revenue from potential COVID-19 treatments.
That’s not certain.
Despite the end of the antibody study on hospitalized patients, Lilly said it remains confident that bamlanivimab monotherapy may prevent the progression of COVID-19.
Several other active trials for potential therapies remain ongoing. Those include an NIH-sponsored study in recently diagnosed mild to moderate patients; Lilly’s ongoing phase 2 trial on recently diagnosed people in the non-hospitalized setting; and Lilly’s phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities.