Lilly reports promising mid-stage data for LY-CoV555 in COVID-19
Eli Lilly announced Wednesday interim findings from a Phase II study of LY-CoV555 in mild-to-moderate recently diagnosed COVID-19 patients, with the SARS-CoV-2 neutralising antibody shown to reduce the rate of hospitalisations and emergency room (ER) visits compared to placebo. The company also reported that at the middle dose level of 2800 mg, LY-CoV555 achieved the trial's primary endpoint of change from baseline in viral load at day 11.
"These interim data from the BLAZE-1 trial suggest that LY-CoV555…has a direct antiviral effect and may reduce COVID-related hospitalisations," remarked Daniel Skovronsky, Lilly's chief scientific officer. The executive added "the results reinforce our conviction that neutralising antibodies can help in the fight against COVID-19."
The BLAZE-1 study is designed to assess the efficacy and safety of LY-CoV555, as well as another antibody LY-CoV016, for the treatment of symptomatic COVID-19 in the outpatient setting. In the monotherapy arms of the trial, patients with mild-to-moderate recently diagnosed COVID-19 were randomised to receive placebo or LY-CoV555 at a dose of 700 mg, 2800 mg or 7000 mg. The study's main goal was change from baseline to day 11 in SARS-CoV-2 viral load, while secondary endpoints include the percentage of participants who experience COVID-19-related hospitalisation, ER visit or death, from baseline through day 29.
Only mid-dose hits main goal
Lilly noted that while the primary endpoint was met at the 2800-mg dose level of LY-CoV555, the other doses failed to achieve this goal. The company indicated that "most patients," including those receiving placebo, demonstrated near complete viral clearance by day 11. However, further analyses of viral data demonstrated that LY-CoV555 improved viral clearance at day three and also reduced the proportion of patients with persistently high viral load at later time points, findings that Lilly said correlated with the antibody therapy's "positive impact" on hospitalisations and ER visits.
Specifically, COVID-19-related hospitalisation or ER visit occurred in 1.7% of the 302 patients who received LY-CoV555 at any dose, compared to 6% of the 150 participants given placebo. Lilly noted that this corresponds to a 72% risk reduction, although it did not say whether the difference was statistically significant. In addition, exploratory analyses indicated a more rapid improvement in symptoms for patients treated with LY-CoV555 versus placebo.
According to Lilly, LY-CoV555 was well tolerated in the study, with no drug-related serious adverse events reported. The drugmaker added that treatment-emergent adverse events were similar across all dose groups and comparable to placebo. The company also said that it plans to "quickly publish" the results in a peer-reviewed journal and discuss appropriate next steps with global regulators
LY-CoV555, which is directed against the spike protein of SARS-CoV-2, emerged from a collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Along with the BLAZE-1 study, which is ongoing and enrolling a larger, confirmatory cohort of higher risk patients, the therapy is also being investigated in the Phase III BLAZE-2 trial for the prevention of COVID-19 in residents and staff at long-term care facilities.