Indianapolis-based Eli Lilly and Co. said it is reviewing safety data that caused federal researchers to pause a trial of the company’s COVID-19 antibody treatment in hospitalized patients. In the meantime, other trials using lower doses of the drug outside the hospital will continue.
On Tuesday, Lilly said enrollment had been paused in the ACTIV-3 trial of its monoclonal antibody treatment sponsored by the National Institutes of Health. The trial is testing a high-dose version of the treatment combined with the drug remdesivir, considered to be a standard of care. To date, the study has enrolled 326 participants who are hospitalized with COVID-19.
While that trial is in limbo, the drugmaker said on Wednesday that the independent data safety monitoring board that recommended the pause hasn’t called for similar actions to be taken in another government-run trial it is overseeing, known as ACTIV-2. A Lilly spokesperson said it also had not affected other trials that use much lower doses in non-hospitalized patients.
“At this time, only the DSMB has reviewed the data from the trial, and NIH leadership and Lilly remain blinded to the ongoing trial results,” the company said in a statement on its website. “Lilly trusts the judgment of the independent DSMB and supports its decisions to exercise caution in ensuring the safety of the patients participating in this study.”
Shares of Indianapolis-based Lilly were down 1%, to $148.54 each, in early-afternoon trading.
In a statement, the National Institute of Allergy and Infectious Disease said that the monitoring board would review the data at a previously planned meeting on Oct. 26 and decide then whether enrollment should resume.
The trial was stopped because early results showed a difference in clinical status after five days between those who received the Lilly drug and those who received placebo, reaching what it called “a predefined boundary for safety,” NIAID said, without providing more detail.
Lilly is one of several companies developing monoclonal antibody therapies, which are seen as a potential bridge to a vaccine. They are being studied as a way to keep people with early COVID-19 symptoms from developing severe cases, as well as in those who have been hospitalized after becoming infected. They’re also being studied as a preventive treatment for nursing homes and other high-risk outpatient settings.
The class of treatments was spotlighted when President Donald Trump received a similar therapy developed by Regeneron Pharmaceuticals Inc after he was infected. Both Lilly and Regeneron have approached the Food and Drug Administration seeking emergency use authorization for their treatments.
Antibodies are powerful anti-infective treatments, but they are generally thought to work best at early stages of the disease. They work by disarming viral particles so they can’t infect cells. It remains unclear how well they would do in later stages of the disease, where an immune system response that spirals out of control is thought to be a major driver of harm.
The antibody treatment Lilly has developed with its Canadian partner AbCellera Biologics Inc. is being studied in multiple settings, and by multiple stakeholders.
While the ACTIV-3 trial on pause excludes severe COVID-19 patients that require ventilators, it involves patients whose COVID-19 has progressed enough so that they require hospitalization. Patients may have had worsening symptoms for as long as 12 days before entering the trial.
Additionally, all of the participants were given Gilead Sciences Inc.’s remdesivir whether they received Lilly’s antibody therapy or a placebo.
Lilly has been aggressive in producing the drug, LY-CoV555, with an estimated 1 million doses of the 700 milligram form available in the fourth quarter, including 100,000 before the end of this month. In ACTIV-3, however, those who get the antibody treatment receive a dose of 7,000 milligrams.
Lilly has approached U.S. regulators for an emergency use authorization for a healthier group of patients: those deemed high-risk with a recent diagnosis of mild-to-moderate COVID-19. The companies have advocated for emergency clearance on the basis of the BLAZE-1 trial involving patients with milder, earlier cases that don’t immediately need hospital care.
The idea behind that study, which is sponsored by Lilly, is to slow the virus down enough that patients never get sick enough to have to go to the hospital. Patients with signs of more serious illness, such as low blood oxygen levels, are excluded.
Were Lilly to receive an emergency use authorization, the U.S. would green light a 700-milligram formulation of its treatment, which has demonstrated robust safety and efficacy, according to the drug companies. Meanwhile, Lilly is also studying a cocktail of two antibodies, and expects to approach regulators for authorization in November and seek full approval in the second quarter of 2021.