Lilly Teams Up With GSK, Vir to Test Antibody Combination Against COVID-19

Eli Lilly is expanding the ongoing phase 2 BLAZE-4 trial to include testing a combination of its antibody treatment bamlanivimab with VIR-7831, a dual-action antibody being co-developed by GlaxoSmithKline and Vir Biotechnology, for use in low-risk patients with mild-to-moderate COVID-19, the companies announced Wednesday. The parties noted that the collaboration marks the first time that monoclonal antibodies from separate companies will be brought together to explore potential outcomes in COVID-19.

Daniel Skovronsky, president of Lilly Research Laboratories, said “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 utilised.” Bamlanivimab, also known as LY-CoV555, is authorised for emergency use in the US for the treatment of mild-to-moderate COVID-19 in high-risk patients.

Shield against new variants

Bamlanivimab is a neutralizing antibody directed against the spike protein of SARS-CoV-2 designed to block viral attachment and entry into cells, while VIR-7831 was selected for development based on its potential to both inhibit viral entry into healthy cells and clear infected ones, as well as provide a barrier to resistance. Vir has said that VIR-7831 was able to neutralize SARS-CoV-2 in preclinical testing by binding to a “highly conserved” epitope it shares with the original SARS virus, potentially making it “more difficult for escape mutants to develop.”

BLAZE-4, which has an estimated enrollment of 700 patients with mild-to-moderate COVID-19 disease, is evaluating bamlanivimab against placebo both as monotherapy and in combination with monoclonal antibodies. Aside from VIR-7831, the randomized study also has an arm testing co-administration of bamlanivimab with Eli Lilly’s etesevimab.

Follows positive BLAZE-1 data

Earlier this week, Eli Lilly reported that bamlanivimab plus etesevimab reduced COVID-19-related hospitalizations and deaths by 70% in high-risk patients recently diagnosed with SARS-CoV-2 in the BLAZE-1 trial. The drugmaker also said this week it will move a new COVID-19 antibody therapy to clinical trials targeting a SARS-CoV-2 variant that was first identified in South Africa.

Meanwhile, Vir chief executive George Scangos remarked “we believe that VIR-7831 has significant potential as a single agent,” saying the company is looking forward to readouts from the phase 3 COMET-ICE and ACTIV-3 studies evaluating its antibody for early treatment and in hospitalized COVID-19 patients. However, he said that “as the virus continues to evolve…we should pursue all possibilities to help end the pandemic,” and BLAZE-4 “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.”