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Eli Lilly said Wednesday a monoclonal antibody treatment is effective in reducing levels of the virus that causes Covid-19 in patients, and also appears to prevent patients from visiting the emergency room or hospital.

Lilly had previously released results for a similar treatment using one antibody, which experts viewed as promising. But the new results, of a combination of two antibodies, appear, based on limited data provided in a press release, to be more robust. The results also appear roughly similar to those Regeneron presented last week of its own cocktail of two monoclonal antibodies. Last Friday, President Trump was treated with the Regeneron monoclonal antibodies.

Monoclonal antibodies are synthetic versions of the antibodies that are one of the main weapons of the immune system. Researchers believed that injecting them into patients could help treat them.

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The patients in the study were sick with Covid-19, but had not been admitted to the hospital. Eli Lilly said that in a preliminary analysis the antibody combination reduced the amount of virus in nasal swabs of patients after 11 days.

Key data, including the actual viral loads of patients and the makeup of the study population, were not included in the press release.

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In the study, 112 patients received 2.8 grams of each of the antibodies, and 156 received placebo. The difference in viral load was statistically significant at day 11, unlike some doses of Lilly’s single-antibody cocktail. There was also a statistically significant reduction in viral levels three days and seven days after infection.

The treatment also improved symptoms, according to a scored questionnaire, and resulted in fewer hospital and emergency room visits. Visits to the hospital or ER were made by 5.8% of patients in the placebo group, but just 0.9% of those who received the antibody combination. That difference, however, was just barely statistically significant.

Lilly said that it has already begun talking to regulators around the world about its single antibody treatment, and has filed with the Food and Drug Administration for an emergency use authorization. It expects to submit a request for emergency use authorization for the combination therapy next month, after patients are enrolled in clinical trials and supply has been manufactured. It could submit for full FDA approval of the combination treatment by the middle of next year.

Lilly said it anticipates it could have as many as 1 million doses of its one-antibody treatment, LY-CoV555, available in the fourth quarter of 2020, with 100,000 available this month. But for the combination therapy, just 50,000 doses will be available in the fourth quarter of 2020.

Both antibody regimens have been well-tolerated, with no serious side effects, the company said. In the single-antibody studies, there have been reactions to the infusion of the treatment, which is given intravenously, including two “serious infusion reactions,” from which patients recovered.

  • It seems that companies are jumping the gun with applications for Emergency Use Authorization based on really low study numbers. Has Lilly thoroughly investigated the “serious infusion reactions” ? relative to what (low) number of study subjects? Of course we need treatment for Covid, but there very well could be an unexpected as of yet unforeseeable cost due to low study ###.

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