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Eli Lilly’s COVID-19 antibody treatment shows promise



A study New England Journal of Medicine (NEJM) This week showed that Eli Lilly’s COVID-19 convalescent plasma-derived virus-neutralizing monoclonal antibody treatment (LY-CoV555) reduced the viral load, reduced the severity of symptoms, and had no serious adverse effects on outpatients .

Data from the Phase 2 clinical trial confirmed the preliminary results of outpatients from a smaller cohort (ie, outpatient visits) in September, and the results were similar.

Animal studies on neutralizing antibodies have shown encouraging results. The viral load of the upper and lower respiratory tracts is significantly reduced. Among them, SARS-CoV-2 (the virus that causes COVID-1

9) is believed to be combined with disease and cause disease . Neutralizing antibodies such as LY-CoV555 will attach to the synaptic protein of SARS-CoV-2 to prevent viruses from attaching and entering cells in the upper and lower respiratory tracts.

A test for blocking virus attachment and cell entry using SARS-CoV-2 neutralizing antibody (BLAZE-1) administered different doses of LY-CoV555 to outpatients who were recently diagnosed with mild or moderate COVID-19. The trial is part of an ongoing study that is investigating multiple treatment options and will eventually recruit more than 800 participants.

From June 17 to August 21, researchers randomly assigned 452 COVID-19-positive patients with mild or moderate symptoms at 41 locations in the United States to receive a single 1-hour intravenous infusion of three doses of LY- CoV555 (700-, 2,800 and 7,000 mg [mg]; 309 patients) or placebo (143 patients). On the 11th day, the patient was evaluated for post-infusion viral load, and clinical outcomes such as hospitalization, emergency room visit or death until 29 days and treatment safety were evaluated.

Reduced viral load and severe symptoms

The study authors found that the viral load of patients receiving the 2800 mg dose was significantly reduced, which was 3.4 times lower than the baseline placebo level (-0.53, 95% confidence interval) [CI], -0.98 to -0.08; P = 0.02). For patients receiving 700 mg and 7,000 mg doses, the reduction in viral load was smaller.

Compared with the placebo group, patients who received any dose of LY-CoV555 had lower severity of symptoms from day 2 to day 6 (from asymptomatic “0” to severe symptoms “3”). Before the 11th day, the baseline symptom score of the treatment group continued to be better than that of the placebo group, and the safety of the two groups was similar.

The rate of hospitalization or emergency room visits related to COVID-19 in the antibody group was 1.6% (5 out of 309 cases), while it was 6.3% in the placebo group (9 out of 143 cases), indicating a higher virus clearance rate and There is an association between lower hospitalization rates. The hospitalization rate for patients 65 or older with a body mass index of 35 or higher was even more alarming, with 4% and 15% in the antibody group and placebo group, respectively.

Compared with the placebo group, no patients in the LY-CoV555 group had serious adverse events. The percentages of all adverse events were similar: 22.3% in the treatment group and 24.5% in the placebo group.

The study authors concluded: “These data show that the therapy is safe.” “Patients treated with LY-CoV555 had fewer hospitalizations and a lighter burden of symptoms than patients treated with placebo, and the most obvious effects were observed in high-risk groups If these results are confirmed in other analyses of this trial, LY-CoV555 can become a useful treatment for emergency use by patients who have recently been diagnosed with Covid-19.”

The trial of the hospital patient is suspended

The interim analysis was the first day after the National Institutes of Health cancelled the clinical trial of 326 hospitalized patients of LY-CoV555 and found that this patient population is unlikely to improve the outcome.

On October 13th, the Data and Safety Monitoring Board (DSMB) triggered the suspension of study enrollment. At that time, the preset safety limit was exceeded, indicating that the clinical conditions of the treatment group and the placebo group were different. In the end, no major safety hazards were found. The reason DSMB recommended to stop the trial this week was the lack of clinical benefit in hospitalized patients.

Scientists at Eli Lilly suspect that inpatients (rather than outpatients) may show a lack of clinical benefit from LY-CoV555 compared to non-inpatients because of longer infections, more severe symptoms, and different treatments.

“For these reasons, hospitalized patients may not benefit from neutralizing antibodies. Neutralizing antibodies are a supplement to the patient’s own immune system, because they may have developed their own endogenous antibody response and are in a situation characterized by viral inflammation. Stage of disease”, the company wrote in a press release on October 14.

Potential for early intervention

Eli Lilly’s researchers still believe that LY-CoV555 can prevent disease progression in early COVID-19 patients. The second phase of outpatient research and the planned third phase of antibody therapy for residents and employees of long-term care facilities continue to move forward.

Peter Chen, MD of Cedars-Sinai in Los Angeles and lead author of the NEJM study, said: “It is important to treat people with COVID-19 as soon as possible after diagnosis to prevent the development of more serious diseases.” Eli Lilly’s press release this week . He added: “Our findings suggest that neutralizing antibodies may be useful in this kind of early intervention.”


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