First Patient Dosed in Trial of Two Separate COVID-19 Therapies

Eli Lilly and Company, Vir Biotechnology, and GSK recently collaborated to evaluate a combination of two COVID-19 therapies in low-risk patients with mild to moderate coronavirus.

Eli Lilly and Company is expanding its ongoing BLAZE-4  trial to evaluate its bamlanivimab 700 milligrams and VIR-7831 500 milligrams, both of which can bind to different epitopes of the SARS-CoV-2 spike protein. 

The collaboration is the first time the monoclonal antibodies from separate companies will be combined to explore potential outcomes.

"With a virus like SARS-CoV-2, it's expected that variants could emerge that require new therapeutic options, which is why Lilly is studying bamlanivimab together with other neutralizing antibodies, including etesevimab,” Daniel Skovronski, MD, PhD, Eli Lilly and Company’s chief scientific officer and president of Lilly Research Laboratories, said in the announcement.

“Adding VIR-7831 to our study is an important part of our commitment to develop therapies to treat current and future strains of COVID-19 until vaccines are widely available and utilized,” Skovronski continued. 

Bamlanivimab (LY-CoV-555) is a neutralizing antibody directed against the spike protein of SARS-CoV-2 and designed to block viral attachment and entry into human cells, Eli Lilly and Company explained. Essentially, the antibody neutralizes the coronavirus.  

In mid-November, FDA issued an emergency use authorization for bamlanivimab for use in mild to moderate coronavirus in adults and pediatric patients. 

The agency based its authorization on available evidence from the Phase 2 BLAZE-1 trial that evaluated 465 non-hospitalized COVID-19 patients and found that bamlanivimab reduced viral load, symptoms, and hospitalization rates. 

One month later, Eli Lilly and Company and UnitedHealth Group partnered to conduct a pragmatic study of bamlanivimab in nearly 500,000 high-risk individuals under real-world conditions.

The study will detect symptomatic patients infected with COVID-19 and track their symptoms, provide in-home COVID-19 testing, and in-home infusion services. 

GSK and Vir Biotechnology’s dual-action monoclonal antibody, VIR-7831, has potential to block viral entry into health cells, clear infected cells, and provide a high barrier to resistance. 

At the beginning of September, GSK and Vir Biotechnology dosed the first patients in a Phase 2/3 study to assess the safety and tolerability of a single 500 milligram intravenous infusion of the antibody versus placebo in 20 patients over a period of 14 days. 

Then in October, the companies announced the global expansion of a Phase 3 study of the antibody. The study will evaluate the antibody in patients who are at high risk of hospitalization from COVID-19.

The expansion will reach sites in North America, South America, and Europe, with full results of the study expected early this year.  

"We should pursue all possibilities to help end the pandemic and maximize the number of lives that can be saved,” George Scangos, PhD, chief executive officer of Vir Biotechnology, said in the recent announcement. 

“This trial is a first step to assess whether the administration of VIR-7831, with its high barrier to resistance and potent effector function, alongside bamlanivimab, which has strong outcomes data in early treatment, can provide potential benefits beyond monotherapy,” Scangos continued. 

Hal Barron, chief scientific officer and president of research and development at GSK, stated that despite notable progress on vaccines in recent months, there is an “urgent need” for additional therapeutic approaches to help prevent the severe consequences of COVID-19. 

In mid-January, The National Institutes of Health (NIH) launched a Phase 2/3 clinical trial to evaluate two COVID-19 antibody therapies, BRII-196 and BRII-198, manufactured by Brii Biosciences. 

A total of 220 participants will be enrolled in the trial, with half receiving the antibodies and half receiving the placebo. Participants will either attend clinical visits or receive at-home visits to track their condition for 72 weeks following the trial.

If both antibodies prove effective, the trial will move to Phase 3 and will enroll nearly 622 additional outpatient volunteers, for a total of 842 trial participants.