Regeneron and Eli Lilly Pause Antibody Cocktail Trials On Hospitalzed Patients; Moderna Preps for Global Vaccine Launch
Regeneron’s lab developing antibody medicines.

Regeneron Pharmaceuticals suspended enrollment of critically ill and hospitalized patients in its COVID-19 antibody cocktail treatment clinical trial on Friday, due to what it said was a safety concern. 

The pharma company’s independent data monitoring committee (IDMC) recommended this pause “based on a potential safety signal and an unfavorable risk/benefit profile,” advising on the collection and analysis of further data. 

Eli Lilly’s antibody treatment clinical trial, examining the efficacy of bamlanivimab, was meanwhile halted altogether for hospitalized COVID-19 patients, after initial trial data suggested that the drug was unlikely to help them recover. 

The Regeneron decision to pause applies to hospitalized patients receiving mechanical ventilation or high-flow oxygen and was taken following the recommendation by the IDMC. The trial will continue the enrollment of patients requiring no or low-flow oxygen. 

Some experts suggested that biologically the treatment could attack the virus better earlier on, but an overactive immune response could reduce the efficacy of the drug cocktail. The safety issues in patients severely ill with COVID-19 do not necessarily raise concerns about the safety for those with mild to moderate illness. 

“There is a tiny window and it’s the earlier the better,” said Eric Topol, director of the Scripps Research Translational Institute, in an interview with Financial Times. He emphasized the need to treat COVID-19 early or preventatively.

Regeneron’s announcement comes after the company revealed early results on Wednesday that their drug cocktail reduced COVID-19 related medical visits by 57 percent overall and 72 percent in patients with one or more risk factors. 

George Yancopoulos, CEO of Regeneron

“Today’s analysis…prospectively confirms that REGN-COV2 can indeed significantly reduce viral load and further shows that these viral reductions are associated with a significant decrease in the need for further medical attention,” said George Yancopoulos, President and Chief Scientific Officer of Regeneron. 

We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors,” he added. 

Regeneron’s decision to pause enrollment is seen as the second recent setback for a COVID-19 antibody therapy. The first was the suspension of Eli Lilly’s monoclonal antibody trial on hospitalized patients last week.  

Eli Lilly’s Clinical Trial Halted by NIH
Eli Lilly researchers developing a COVID-19 antibody treatment.

The independent Data and Safety Monitoring Board recommended to the National Institutes of Health (NIH), the sponsor of the Eli Lilly trial, that no further hospitalized COVID-19 patients receive the drug, because of a “low likelihood that the intervention would be of clinical value in this hospitalized patient population.” 

The discontinuation of the trial “tells us they stopped the trial due to futility” and “suggests that the timing of monoclonal antibody administration – early – will be important,” said Topol to the New York Times

Trials of the drug will continue in patients with mild to moderate COVID-19. 

“While there was insufficient evidence that bamlanivimab improved clinical outcomes when added to other treatments in hospitalized patients with COVID-19, we remain confident based on data from Lilly’s BLAZE-1 study that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of COVID-19,” said Eli Lilly in a statement

Both Eli Lilly and Regeneron submitted emergency use authorization requests to the US Food and Drug Administration (FDA) in early October to treat patients with mild to moderate COVID-19. 

Front-runner Moderna in COVID-19 Vaccine Race Prepares for Global Launch 

Meanwhile, Moderna announced on October 22 that their Phase 3 clinical trial for a potential COVID-19 vaccine completed the enrollment of 30,000 participants. The biotechnology company is preparing for the global launch of its potential vaccine. 

Stéphane Bancel, CEO of Moderna

Among the trial participants, 37 percent are from diverse communities and 42 percent are at high risk of severe COVID-19 disease, either over the age of 65 or with co-morbid risk factors. All participants have received their first shot of the vaccine candidate and the majority have received the second. 

Moderna is currently on track to file an emergency use authorization to the FDA in late November, if they gather sufficient safety and efficacy data, as announced by Moderna CEO, Stéphane Bancel, in early October. 

“We are actively preparing for the launch of mRNA-1273 and we have signed a number of supply agreements with governments around the world,” said Bancel in a press release on Friday. “Moderna is committed to the highest data quality standards and rigorous scientific research as we continue to work with regulators to advance mRNA-1273.”

Britain Health Regulator Began Rolling Review of AstraZeneca’s COVID-19 Vaccine

In Britain, the Medicines and Healthcare Products Regulatory Agency (MHRA) started an accelerated rolling review of AstraZeneca’s potential COVID-19 vaccine, produced in collaboration with researchers at the University of Oxford.

“We confirm the MHRA’s rolling review of our potential COVID-19 vaccine,” said an AstraZeneca spokesperson to Reuters on Sunday. 

AstraZeneca scientist developing potential COVID-19 vaccine.

The health regulator will analyze trial data and potentially accelerate the approval process, if the data reveals that the vaccine is safe and effective. This review helps fast track potential vaccines and drugs in ongoing trials. 

On Wednesday, the MHRA began a rolling review of Moderna’s vaccine candidate and a review of Pfizer’s vaccine candidate also started recently. These three pharmaceutical companies, along with Johnson & Johnson, are leading the race to develop a COVID-19 vaccine. 

Image Credits: Regeneron, Regeneron, Eli Lilly, Moderna, AstraZeneca.

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