Eli Lilly and Company
The candidate, LY-CoV555, had helped shorten hospitalizations and emergency room visits for COVID-19 patients in back in September, with positive data from a Phase II clinical trial testing its combination antibody therapy demonstrating similar results on Wednesday.
Lilly's treatment is designed to prevent the progression of a COVID-19 patient's infection by introducing SARS-CoV-2 neutralizing antibodies into an individuals immune system.
In a total of 268 patients with mild-to-moderate COVID-19 infection, nearly 1% given of combination of Lilly's two antibody treatments--LY-CoV555 and LY-CoV016--had to be hospitalize, compared to 5.8% on given placebo. The combination therapy's trial had also met researcher's main goal of significantly reducing patient's viral loads 11 days after receiving treatment, with the candidate reducing viral levels at day 3 and day 7.
The company said it will request an E.U.A. for its combination therapy in November, once more safety data is available from on going clinical trials and enough doses are made. Lilly expects to produce 100,000 doses of Ly-CoV555 this month and expects 50,000 doses of the combination therapy to be available by the fourth quarter of 2020.
Eli Lilly is not the only company developing neutralizing antibodies to help treat COVID-19 infection. Rival Regeneron Pharmaceutical's
No antibody treatments have been authorized for use in the treatment of COVID-19 patients in the United States and clinical trials testing the drugs are still ongoing.
Vaccine Update
The F.D.A. on Tuesday released new safety standards for COVID-19 vaccine candidates to follow in order to receive an E.U.A. from the federal regulatory agency. These new standards were previously blocked by the Trump administration for formal release.
Most notably, the new guidelines call for vaccine developers to continue to follow-up on clinical trial participants for at least two months following the completion of the vaccine candidate's Phase III studies before seeking an E.U.A. This recommendation is an added safety measure to make sure participants do not develop any major side effects.
The Trump administration disagrees with the new emergency vaccine approval standards, arguing that they will only unreasonably delay the availability of effective vaccines when the public needs them as soon as possible.
Nevertheless, the F.D.A. posted the guidance, again reiterating that the approval of a COVID-19 vaccine will be based on scientific evidence and proven data and will be conducted separate from politics.
F.D.A. Commissioner Stephen Hand said in a statement, reported by the Associated Press, that he hoped the new guidelines will help, "the public understand our science-based decision-making processes that assures vaccine quality, safety and efficacy."
