Lilly starting new trial for COVID-19 antibody, potentially widening already red-hot market

When it rains, it pours with news about Eli Lilly and Co.’s treatment for COVID-19.

In recent weeks, the Indianapolis drugmaker has won U.S. approval for emergency use of its neutralizing antibody for the treatment of mild-to-moderate COVID-19 patients. That led to CVS Health Corp. announcing it will administer the treatment, called bamlanivimab, in patients’ homes and in long-term care facilities. And if that weren’t enough, Lilly said Wednesday that the federal government has purchased 650,000 additional doses.

Add it all up, and there’s a better than even chance that Lilly will face huge demand for the antibody and will have to deal with shortages and possible rationing.

But Lilly has more moves up its sleeve.

The company announced on Friday that it’s partnering with health insurer UnitedHealth Group to conduct a study of the drug in high-risk, COVID-19 infected individuals. That study, if successful, could open a wider market for the drug and increase demand further.

The study will enroll up to 500,000 people, with at least 5,000 people expected to receive bamlanivimab therapy. It will assess the efficacy and safety of bamlanivimab versus a “propensity matched cohort” for the treatment of symptomatic COVID-19 in the outpatient setting. The companies did not say what the cohort would be.

Eligible patients who test positive for COVID-19 will receive a one-time infusion in their homes of 700 mg bamlanivimab. The primary objective is to determine whether the patients who get the drug are admitted to a hospital by the 28^th day of the study, compared to patients in the control group. The trial will also study safety as well as COVID-related mortality at day 28.

The study will identify and treat a large, diverse population of high-risk individuals for COVID-19 with bamlanivimab under real-world conditions, rather than in an overnight clinic or hospital setting. The goal is to see whether bamlanivimab can reduce the severity of illness and hospitalizations.

The study will draw upon both UnitedHealth Group’s health benefits business as well as its Optum health services business to detect and treat high-risk symptomatic patients who test positive for COVID-19, including daily symptom tracking, in-home SARS-CoV-2 testing and in-home infusion services.

Delivering bamlanivimab to patients through home infusions allows them to stay quarantined and at home, minimizing the potential spread of COVID-19. The antibody works by imitating the immune system’s attack on the virus.

Lilly said those who volunteer and are accepted into the study will be directed to download Optum’s symptom-checking ProtectWell app and complete a daily questionnaire. Participants experiencing symptoms of COVID-19 will take an in-home SARS-CoV-2 test which they will self-administer and return. Those that are COVID-19 positive will receive outreach from a nurse to schedule a home infusion treatment of bamlanivimab.

“While bamlanivimab is authorized for emergency use based on the efficacy and safety data accumulated to date, larger pragmatic studies in diverse populations can help us further understand the efficacy and safety of SARS-CoV-2 neutralizing antibodies in real world settings,” said Dr. Daniel Skovronsky, Lilly’s chief scientific officer, in a written statement.

Both Lilly and UnitedHealth point out that bamlanivimab has not been approved by the Food and Drug Administration use, and there are still many questions about its usefulness.  It is not known if bamlanivimab is safe and effective for the treatment of COVID-19. Bamlanivimab is authorized under an Emergency Use Authorization during the pandemic.

And not all the news about the antibody has been positive. In October, the National Institute of Allergy and Infectious Diseases halted a study of the drug that it had sponsored for hospitalized patients, saying it found a low chance that the drug would prove helpful for that patient group.

As part of his VIP treatment regimen, President Trump received an experimental antibody drug made by Regeneron Pharmaceuticals through a compassionate use program. Chris Christie, former Republican governor of New Jersey, received access to the Eli Lilly drug.

The number of doses available is likely to be greatly outmatched by soaring need, with more than 500,000 coronavirus cases counted over the past week alone. By the end of the year, Lilly projects 1 million doses could be available. The U.S. government has contracted to purchase 950,000 doses so far.