Data for Lilly’s bamlanivimab (LY-CoV555) in COVID-19 outpatients published in New England Journal of Medicine
INDIANAPOLIS, Oct. 28, 2020 /PRNewswire/ — The New England Journal of Medicine has published data from the monotherapy arms of BLAZE-1, a Phase 2 study assessing the efficacy and safety of Eli Lilly and Company’s (NYSE: LLY) bamlanivimab (LY-CoV555) – a neutralizing antibody – in the COVID-19 outpatient setting. This study focused on ambulatory COVID-19 patients being treated in the outpatient setting, whose symptoms did not require hospitalization at the time of enrollment. The publication, which can be found here, follows Lilly’s proof-of-concept data announcement for bamlanivimab as monotherapy in September 2020.
“The publication of these data in a peer-reviewed journal adds to the growing body of evidence for the potential utility for neutralizing antibodies as therapeutics for people recently diagnosed with mild to moderate COVID-19, particularly high-risk patients,” said Ajay Nirula, M.D., Ph.D., vice president of immunology at Lilly and co-first author of the study. “These data show bamlanivimab may be effective in treating COVID-19 by reducing viral load, symptoms and the risk of hospitalization in outpatients.”
“It is important to treat people with COVID-19 as soon as possible after diagnosis in order to forestall development of more severe disease,” said Peter Chen, M.D., director of Pulmonary and Critical Care Medicine at Cedars-Sinai and co-first author of the study. “Our findings indicate that neutralizing antibodies may have the potential to be useful in this early-stage intervention.”
These data were submitted as part of Lilly’s request for an emergency use authorization from the U.S. Food and Drug Administration for bamlanivimab in higher-risk patients who have been recently diagnosed with mild to moderate COVID-19.
BLAZE-1 ( NCT04427501 ) is a randomized, double-blind, placebo-controlled Phase 2 study designed to assess the efficacy and safety of bamlanivimab alone or in combination with a second antibody for the treatment of symptomatic COVID-19 in the outpatient setting. To be eligible, patients were required to have mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than three days prior to drug infusion.
The monotherapy arms of the trial enrolled mild to moderate recently diagnosed COVID-19 patients, studying three doses of bamlanivimab (700 mg, 2800 mg, and 7000 mg) versus placebo.
The primary outcome measure for the completed arms of the BLAZE-1 trial was change from baseline to day 11 in SARS-CoV-2 viral load. Additional endpoints include the percentage of participants who experience COVID-related hospitalization, ER visit or death from baseline through day 29, as well as safety.
The study is ongoing with additional treatment arms. Across all treatment arms, the trial will enroll over 800 participants.
Data from the BLAZE-1 study show bamlanivimab may be effective in treating COVID-19 by reducing viral load, symptoms and the risk of hospitalization in patients recently diagnosed with mild to moderate COVID-19. In the BLAZE-1 trial, rates and types of adverse events were similar between bamlanivimab and placebo, with the majority being mild to moderate in severity and with no drug-related serious adverse events reported thus
The number of new cases of COVID-19 recorded across the United States has increased substantially, as has the number of new deaths from the disease, according to an internal memo from the U.S. Department of Health and Human Services that was obtained by ABC News on Monday night.
The memo, which is circulated among the highest levels of the federal government and is used to determine daily priorities for the agencies working on a COVID-19 response, said 40 U.S. states and territories are in an upward trajectory of new infections, while nine jurisdictions are at a plateau and seven others are in a downward trend.
There were 488,498 new cases confirmed during the period of Oct. 19-25, a 26% increase from the previous week. There were also 5,615 fatalities from COVID-19 recorded during the same period, a 15.1% increase compared with the week prior, according to the memo.
The national positivity rate for COVID-19 tests increased from 5.6% to 6.1% in week-to-week comparisons. Meanwhile, 22% of hospitals across the country have intensive care units that are more than 80% occupied. That figure is up from the summertime peak, when 17-18% of U.S. hospitals had 80% of ICU beds full, the memo said.
Arizona reported 848 COVID-19 hospitalizations on Oct. 21, its highest count since Aug. 26, according to the memo.
In the U.S. territory of Guam, which continues to be classified as a “red zone” for COVID-19 infections, an average of 89.7% of inpatient beds and 80.2% of ICU beds were occupied in the week ending Oct. 20, the memo said.
North Dakota saw a record high of 1,036 new cases on Oct. 20, surpassing the 1,000 mark of daily incident cases for the first time, according to the memo.
New Jersey reported 852 daily COVID-19 hospitalizations on Oct. 22, its highest since late July, the memo said.
Oklahoma reached a record 956 COVID-19 hospitalizations on Oct. 22. The previous record was set just two days earlier, according to the memo.
Utah reported an all-time high of 314 COVID-19 hospitalizations on Oct. 21, as several hospitals in the state reached capacity, the memo said.
ABC News’ Josh Margolin contributed to this report.
In this Fool Live video, Healthcare and Cannabis Bureau Chief Corinne Cardina and longtime Motley Fool contributor Brian Orelli discuss Eli Lilly‘s (NYSE:LLY) monoclonal antibodies that target the novel coronavirus, which causes COVID-19. The company has a pair of antibodies, LY-CoV555 and LY-CoV016 that it’s testing individually and in combination with each other. After the segment was recorded, a phase 3 clinical trial testing LY-CoV555 was paused by the National Institutes of Health, which is running the study.
Corinne Cardina: Let’s talk about Eli Lilly. This company is the oldest of them all. It is 145 years old. It has a $145 billion market cap. It’s based in Indianapolis. Eli Lilly has a portfolio of medicines including treatments in bone, muscle, joint, cancer, cardiovascular, diabetes, endocrine, immunology, neurodegeneration, neuroscience, and pain. That’s a mouthful. They do a lot. They’ve been around for a long time.
In the second quarter of fiscal 2020, their revenue was $5.5 billion, down 2% from the same quarter the prior year. This stock also pays a dividend yielding about 2%. Eli Lilly has a neutralizing monoclonal antibody. They are calling it LY-CoV555. They call this a potent neutralizing immunoglobulin G, which is a type of monoclonal antibody, and it is directed at the spike protein of coronavirus that we just talked about. This was designed to block viral attachment and entry into human cells which would neutralize the virus, potentially prevent, and treat COVID-19.
On Sep. 16, they released proof of concept data from an interim analysis of the phase 2 clinical trial. This showed a reduced rate of hospitalization for patients who were treated with this treatment. Eli Lilly has completed enrollment and the primary safety assessments of the treatment in a phase 1 study of hospitalized patients with COVID-19 and they’re doing an ongoing long-term follow-up. A phase 2 study in people recently diagnosed with COVID-19 is going on on an outpatient basis, so the non-hospitalized patients.
Lilly recently initiated a phase 3 study for the prevention of COVID-19 specifically in residents and staff at long-term care facilities. There’s a big need there, as we know. Then lastly, the treatment is being tested in the National Institutes of Health studies of outpatient and hospitalized patients. On Wednesday, Eli Lilly announced that they had promising data for the combination of this treatment with another of their neutralizing antibody which is LY-CoV016. The company also said that it has asked the FDA for an emergency-use authorization for the initial one, 555. It plans to submit a request for an emergency-use authorization for the combination treatment next month after it gets some more safety data and it has to produce a sufficient supply. This is the second antibody that we’ve talked about. GlaxoSmithKline (NYSE:GSK) and Vir Biotechnology (NASDAQ:VIR) are partnered on one as well. Brian, could you explain what is a neutralizing antibody and how do these treatments differ?
Brian Orelli: Yes. A neutralizing antibody means that the antibody binds to the virus