Eli Lilly and Co. provided additional details on its SARS-CoV-2 neutralizing antibody programs – including interim data on combination therapy in recently diagnosed patients with mild-to-moderate COVID-19 – and plans to make these therapies broadly available to patients.

Data from interim analysis of the BLAZE-1 clinical trial showed that combination therapy with two of Lilly's SARS-CoV-2 neutralizing antibodies reduced viral load, symptoms and COVID-related hospitalization and ER visits. The Phase II study evaluated LY-CoV555 and LY-CoV016, which bind complementary regions of the SARS-CoV-2 spike protein, for the treatment of symptomatic COVID-19 in the outpatient setting. The combination cohort enrolled recently diagnosed patients with mild-to-moderate COVID-19, who were assigned to 2800 mg of each antibody or placebo.

The combination therapy significantly reduced viral load at day 11, meeting the primary endpoint of the study. Combination treatment reduced viral levels at day 3 and day 7, earlier during the course of infection when higher viral loads are typically seen. Combination therapy also significantly reduced the time-weighted average change from baseline from day 1 to 11. An exploratory analysis showed that the proportion of patients with persistent high viral load at day 7 for combination therapy was lower (3.0 percent) versus placebo (20.8 percent). No emergent putative resistance variants have been observed thus far in patients treated with combination therapy.

Combination therapy also met prespecified clinical endpoints, including the time-weighted average change from baseline in total symptom score from day 1 to 11. The improvement in symptoms was observed as early as three days after dosing and was similar in magnitude and timing to improvements previously seen with LY-CoV555 monotherapy. The rate of COVID-related hospitalization and ER visits was lower for patients treated with combination therapy (0.9 percent) versus placebo (5.8 percent), a relative risk reduction of 84.5 percent. This was also similar to observations for LY-CoV555 monotherapy.

Manufacturing and Supply Update

Lilly previously invested in large-scale manufacturing of both antibodies before data demonstrated their potential to become a meaningful therapeutic option for COVID-19.

For monotherapy, Lilly is focused on the 700 mg dose of LY-CoV555 and anticipates it could supply as many as one million doses in 4Q20, with 100,000 available in October. For the supply of combination therapy, Lilly anticipates it will have 50,000 doses available in 4Q20. The supply of combination therapy will increase substantially beginning in 1Q21, as additional manufacturing resources come online throughout the year, including Lilly's recently announced manufacturing collaboration with Amgen. Lilly is also pursuing additional partnerships to provide antibodies to resource-limited countries.