Roche’s COVID-19 Antibody Cocktail Reduces Symptoms by 81%

April 15, 2021 - Roche recently confirmed positive results from the Phase 3 trial assessing its COVID-19 antibody cocktail, which aims to reduce coronavirus infection among household contacts of individuals infected with the virus. 

Researchers found that administration of the antibody cocktail, casirivimab and imdevimab, reduced the risk of symptomatic infection by 81 percent in individuals who were not infected when they entered the trial. 

The REGN-COV 2069 trial assessed casirivimab and imdevimab in individuals without COVID-19 antibodies or coronavirus symptoms and who lived in the same household as individuals who tested positive for the virus within the previous four days.

The trial included 1,505 individuals who were not infected with SARS-CoV-2 at baseline and who received either one 1,200-milligram dose of casirivimab with imdevimab or a placebo.

Individuals treated with casirivimab and imdevimab who still experienced a symptomatic infection resolved their symptoms on average within one week. Participants who took placebo resolved their symptoms in three weeks. 

Notably, no new or serious safety signals were observed.

A separate study evaluated the antibody cocktail in a cohort of 204 recently infected symptomatic patients. The patients received either one 1,200 milligram dose of casirivimab and imdevimab or a placebo. 

In this cohort, the cocktail reduced the overall risk of progressing to symptomatic COVID-19 by 31 percent. 

“Although vaccinations are increasing globally, there remains a critical unmet need worldwide to prevent infections and provide immediate protection from COVID-19 between close contacts,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche said in the announcement. 

“This is why we are excited to bring this data to health authorities with the goal of making the combination available to more people as soon as possible,” Garraway concluded.  

AstraZeneca Diabetes Drug Fails in Phase 3 COVID Study 

AstraZeneca and Saint Luke’s Mid America Heart Institute recently announced that AstraZeneca’s diabetes drug, Farxiga, failed in a Phase 3 study.

The DARE-19 trial assessed Farxiga in hospitalized COVID-19 patients who are at risk of developing serious complications, such as hypertension, type-2 diabetes, atherosclerotic cardiovascular disease, heart failure, or chronic kidney disease. 

Researchers found that the trial did not achieve statistical significance for the primary endpoint of preventing measuring organ dysfunction and all-cause mortality, or the primary endpoint of recovery measuring a change in clinical status at 30 days. 

Mikhail N. Kosiborod, MD, cardiologist at Saint Luke’s Mid America Heart Institute stated that although the trial did not meet endpoints, the findings are valuable and will inform future clinical science. 

Eli Lilly Changes US Govt Purchase Agreements for Antibody Therapies

Eli Lilly and Company recently announced that the US Government has agreed to shift its focus to the supply of COVID-19 antibody therapies, bamlanivimab and etesevimab, together. 

The agreement has also been modified to allow the supply of etesevimab to complement doses of bamlanivimab that the US government has already purchased. Some of the doses have already been delivered to care sites. 

The modified agreement terminates the purchase agreement for bamlanivimab alone and cancels the remaining 350,856 doses that were scheduled to be delivered by the end of March 2021.

In mid-February, FDA issued an emergency use authorization for bamlanivimab and etesevimab.  The authorization allows providers to administer the treatment to infected adult and pediatric patients who are 12 years of age or older and weigh at least 88 pounds. 

Thermo Fisher Gains FDA Emergency Authorization for COVID-19 Test 

Thermo Fisher Scientific recently announced that FDA granted emergency use authorization for its COVID-19 High-Throughput Combo Kit.

The Amplitude Solution is a molecular diagnostic testing system that helps clinical labs increase testing capacity.

Specifically, the solution allows clinical and public health laboratories to scale gold standard PCR testing and process up to 8,000 samples in one day with minimal staffing resources and a secured supply of kits, reagents, and consumables to meet testing needs.