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Juan Lama
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AstraZeneca's antibody cocktail against COVID-19, which has proven to work as a preventative shot in the non-infected, was also shown to save lives and prevent severe disease when given as treatment within a week of first symptoms. The drug, a combination of two antibodies called AZD7442, reduced the risk of severe COVID-19 or death by 50% in non-hospitalised patients who have had symptoms for seven days or less, the Anglo-Swedish drugmaker said on Monday. The risk reduction was even better in patients who started therapy within just five days of initial symptoms, but AstraZeneca joins an already crowded field of medicines that were shown to prevent deterioration in patients with mild disease when given soon after diagnosis. AstraZeneca executive Mene Pangalos said in a media call that the treatment results would mainly underscore the potential future use as a non-vaccine prevention.FWN2R716N "If and when this is approved it will be used in the treatment setting as well. But the real differentiator for this antibody is going to be in the prophylactic setting," he said. Similar therapies made with a class of drugs called monoclonal antibodies are being developed by Regeneron (REGN.O), Eli Lilly (LLY.N) and GlaxoSmithKline (GSK.L) with partner Vir (VIR.O). These therapies are approved for emergency use in the United States for treating mild-to-moderate COVID-19. Regeneron's therapy showed 72% protection against symptomatic infection in the first week, and 93% after that. GSK-Vir's showed a 79% reduction in the risk of hospitalisation or death due to any cause, while Eli Lilly's therapy showed a 70% reduction in viral load at day seven compared to a placebo. Merck & Co Inc (MRK.N), in turn, is emphasising the convenience of use of its anti-COVID-19 tablet, which cut the risk of having to got to hospital or of dying by 50% in a trial of early-stage patients who had at least one risk factor. Merck, collaborating with Ridgeback Biotherapeutics, on Monday applied for U.S. emergency clearance for the oral drug. read more AstraZeneca, whose COVID-19 vaccine has been widely used across the globe, asked U.S. regulators last week to grant emergency use authorisation for AZD7442 as a preventative shot. read more As such, it is designed to protect people who do not have a strong enough immune response to vaccines, primarily those who have received organ transplants or who are in cancer care. If full market clearance is obtained after any emergency approval the market could widen, for instance, to include crew and passengers of a cruise ship, said Pangalos. "You can say the same for people who don't want to be vaccinated but want an antibody," he added. AstraZeneca said it is submitting the new treatment data on AZD7442 to global health regulators. The trial took place across 13 countries and involved more than 900 adult participants, 90% of whom suffered from conditions that made the particularly vulnerable to COVID-19, such as cancer and diabetes. One half receiving AZD7442 and the rest a placebo. Full trial results will be submitted for publication in a peer-reviewed journal, AstraZeneca said. AZD7442 contains laboratory-made antibodies designed to linger in the body for months to contain the virus in case of an infection. A vaccine, in contrast, relies on an intact immune system to develop targeted antibodies and infection-fighting cells. While Monday's results cover the use of AZD7442 in non-hospitalised patients, a separate trial is also studying its use as a treatment for hospitalised COVID-19 patients. Reporting by Ludwig Burger in Frankfurt, Yadarisa Shabong in Bengaluru; Editing by Saumyadeb Chakrabarty, Kirsten Donovan and Alexander Smith AstraZeneca Press Release (Oct. 11, 2021): https://www.astrazeneca.com/media-centre/press-releases/2021/azd7442-phiii-trial-positive-in-covid-outpatients.html
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Regeneron cocktail reduces mortality by 20% in those who don’t produce antibodies themselves, RECOVERY trial shows. The world’s largest trial of COVID-19 therapeutics has for the first time produced convincing evidence that a therapy that directly attacks the virus can save hospitalized patients from death. A combination of antibodies called casirivimab and imdevimab, produced by Regeneron, did not lower mortality when all patients in the study were taken together, investigators of the United Kingdom’s Recovery trial announced today—but it reduced deaths by one-fifth among those who did not produce antibodies themselves. A paper with the results will be made available on the medRxiv preprint server later today, the researchers say. “Here you have really the first direct SARS-CoV-2 drug,” says Eric Topol, director of the Scripps Research Translational Institute. Two drugs previously shown to reduce mortality from COVID-19 were developed for other diseases and work by dampening an overactive immune response, which is “kind of an indirect strategy,” Topol says. But Regeneron’s antibodies, which attach to the receptor-binding domain of the spike protein and prevent the virus from entering cells, are expensive and not widely available, and quickly identifying patients that benefit from it may be a challenge. Researchers have developed several monoclonal antibodies against SARS-CoV-2, with mixed results. Some, including Regeneron’s, have shown some positive effects on disease progression in outpatients, but none was demonstrated to save the lives of severely ill patients in the hospital. The Recovery trial started to evaluate Regeneron’s cocktail in mid-September 2020. By late May, 9785 patients had been randomly allocated to receive either the usual care in the United Kingdom or the usual care plus a one-time infusion of the two antibodies, a procedure that takes roughly 1 hour. About one-third of the patients were seronegative when they entered the trial, meaning they did not produce antibodies themselves. That includes people with underlying health conditions that weaken their immune system, but also people who, for unclear reasons, are unable to produce antibodies early on. In this group, 30% of patients given standard care died, versus 24% of those who received the antibody cocktail. That translates to six lives saved for every 100 such patients treated with the drug. The Regeneron cocktail received a lot of attention when former U.S. President Donald Trump received it during his bout with COVID-19 in October 2020. Although it’s not clear whether Trump’s immune system produced antibodies, the new results suggest the treatment may have helped save his life, Topol says: “Who knows what might have happened at his age, with his morbid obesity and all the other risk factors that he had.” Although it received an emergency use authorization from the U.S. Food and Drug Administration in November 2020—and the U.S. government bought 1.5 million doses— Regeneron’s therapy has not been widely used in the United States, Topol says. “This is just sitting on shelves,” he says. “I think [the Recovery trial] is going to wake people up as to the benefit.” But doctors will have to determine which patients fail to produce antibodies. “I think this isn’t a complicated test to run, it just needs to be done,” says Martin Landray of the University of Oxford, one of Recovery’s principal investigators. A bigger challenge may be cost. “We anticipate, but we don’t know this, that they may be around £1000 or £2000 per treatment,” Recovery co-investigator Peter Horby said at a press conference on Tuesday. That might put the therapy and many similar ones in the pipeline out of reach for most people living in developing countries, which also have far fewer COVID-19 vaccine doses than rich countries. Access to antibody drugs in general has been particularly unequal across the globe, says Lindsay Keir, a pediatrician who co-authored a Wellcome Trust report on global access to such treatments released last year. “Antibodies that we have benefited from in high-income countries for 20, 30 years, still aren’t available in many countries,” Keir says. The inequity is a “scandal,” Horby says. “There really must be an initiative to make these drugs accessible, and that requires two things: They have to be available, which means we have to scale up manufacturing, and they have to be affordable, which means we have to reduce the prices.” Original findings available as preprint in medRxiV (June 16, 2021): https://doi.org/10.1101/2021.06.15.21258542 See Recovery trial press release (June 16, 2021): https://www.recoverytrial.net/news/recovery-trial-finds-regeneron2019s-monoclonal-antibody-combination-reduces-deaths-for-hospitalised-covid-19-patients-who-have-not-mounted-their-own-immune-response-1
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Juan Lama
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The US National Institutes of Health (NIH) has announced that preliminary results from a Phase III clinical trial of Eli Lilly and Company’s investigational monoclonal antibody, LY-CoV555, showed it failed to provide clinical benefit in hospitalised Covid-19 patients. Discovered by AbCellera Biologics and the National Institute of Allergy and Infectious Diseases (NIAID)’s Vaccine Research Center, LY-CoV555 is developed and manufactured by Eli Lilly and Company, in collaboration with AbCellera. In October, the trial halted new enrolment after an independent Data and Safety Monitoring Board (DSMB) recommended so. The trial, which is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) programme, is sponsored by NIH unit NIAID. The randomised, placebo-controlled ACTIV-3 trial used a master protocol, which would aid in analysing various investigational agents versus placebo in hospitalised adult patients with Covid-19. In the trial, participants randomly received either an experimental agent or a matched placebo along with the standard of care, including the antiviral remdesivir. The LY-CoV555 sub-study enrolled 326 participants. Around 314 subjects randomly received either LY-CoV555 or placebo. NIH noted that after five days, 50% of those received LY-CoV555 and 54% of placebo recipients were in one of the two most favourable outcome categories. The investigators concluded that LY-CoV555 did not expedite clinical improvement versus placebo at day five in hospitalised Covid-19 patients without end-stage organ failure. In addition, no difference in time to hospital discharge or the primary outcome of sustained recovery, back at home for 14 days were observed among those who received the treatment as compared with placebo. In November, the US Food and Drug Administration granted emergency use authorisation (EUA) to LY-CoV555 to treat non-hospitalised adolescents and adults with mild to moderate Covid-19 symptoms who are at the risk of progressing to severe Covid-19. In August, the NIH initiated a Phase III ACTIV-3 trial to evaluate various types of monoclonal antibodies as potential treatments for hospitalised Covid-19 patients. Separately, three global trials, notably REMAP-CAP, ACTIV-4 and ATTACC, analysing the effects of full doses of anticoagulants (blood thinners) in Covid-19 patients have paused the enrolment for critically ill Covid-19 patients requiring intensive care unit (ICU) support. Findings Published in NEJM (Dec. 22, 2020): https://doi.org/10.1056/NEJMoa2033130
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Scooped by
Juan Lama
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BACKGROUND Patients with underlying medical conditions are at increased risk for severe coronavirus disease 2019 (Covid-19). Whereas vaccine-derived immunity develops over time, neutralizing monoclonal-antibody treatment provides immediate, passive immunity and may limit disease progression and complications. METHODS In this phase 3 trial, we randomly assigned, in a 1:1 ratio, a cohort of ambulatory patients with mild or moderate Covid-19 who were at high risk for progression to severe disease to receive a single intravenous infusion of either a neutralizing monoclonal-antibody combination agent (2800 mg of bamlanivimab and 2800 mg of etesevimab, administered together) or placebo within 3 days after a laboratory diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The primary outcome was the overall clinical status of the patients, defined as Covid-19–related hospitalization or death from any cause by day 29. RESULTS A total of 1035 patients underwent randomization and received an infusion of bamlanivimab–etesevimab or placebo. The mean (±SD) age of the patients was 53.8±16.8 years, and 52.0% were adolescent girls or women. By day 29, a total of 11 of 518 patients (2.1%) in the bamlanivimab–etesevimab group had a Covid-19–related hospitalization or death from any cause, as compared with 36 of 517 patients (7.0%) in the placebo group (absolute risk difference, −4.8 percentage points; 95% confidence interval [CI], −7.4 to −2.3; relative risk difference, 70%; P<0.001). No deaths occurred in the bamlanivimab–etesevimab group; in the placebo group, 10 deaths occurred, 9 of which were designated by the trial investigators as Covid-19–related. At day 7, a greater reduction from baseline in the log viral load was observed among patients who received bamlanivimab plus etesevimab than among those who received placebo (difference from placebo in the change from baseline, −1.20; 95% CI, −1.46 to −0.94; P<0.001). CONCLUSIONS Among high-risk ambulatory patients, bamlanivimab plus etesevimab led to a lower incidence of Covid-19–related hospitalization and death than did placebo and accelerated the decline in the SARS-CoV-2 viral load. (Funded by Eli Lilly; BLAZE-1 ClinicalTrials.gov number, NCT04427501. opens in new tab.) Published in NEJM (July 14, 2021): https://doi.org/10.1056/NEJMoa2102685
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The company believes its antibody could be an option not just to treat Covid-19 but to help prevent it in limited circumstances. Eli Lilly said Thursday that its monoclonal antibody prevented Covid-19 infections in nursing home residents and staff in a clinical trial, the first time such a treatment has been shown to prevent infection. Lilly released the results in a press release, although it said that it would publish the data in a research paper as quickly as possible. In November, the antibody, bamlanivimab, was authorized for emergency use by the Food and Drug Administration in treating patients with Covid who are at risk of more severe disease. An antibody cocktail made by the biotechnology firm Regeneron has also been authorized. But Lilly believes its antibody could be an option not just to treat Covid-19 but to help prevent it in limited circumstances. “Of course, I think the vaccines are more effective than prophylaxis and likely longer lasting,” Daniel Skovronsky, Eli Lilly’s chief scientific officer, said in an interview. “So this should not be seen in any way as competition to vaccines. It should be for when it’s too late, when there’s an outbreak and people are getting exposed and there’s not going to be time for a vaccine to work.” The study, begun Aug. 3, was conducted with the National Institute of Allergy and Infectious Diseases. Lilly used an unusual strategy: a fleet of refitted recreational vehicles that could prepare study drug, do lab work, and pull trailers that could be used as on-site infusion clinics. That meant that when a nursing home or long-term care facility had an outbreak, an RV could be dispatched. Lilly developed the antibody in collaboration with Abcellera, a Vancouver biotech. Lilly enrolled 1,097 participants in the study. Of these, 132 tested positive for the SARS-CoV-2 virus, which causes Covid-19, at the beginning of the study. Of the remaining participants, 300 were residents of long-term care facilities and the rest were facility staff, including health care workers. Among these, 965, symptomatic Covid-19 infections were reduced by 57%. Among the 299 patients who were nursing home residents, the results were stronger still, reducing symptomatic Covid-19 cases by 80%. In both cases the result was statistically significant. There were four deaths among the 965 patients, all of them in the placebo group. When the 132 who tested positive at the study’s beginning were included, there were another four deaths — again, only among patients who received placebo. All deaths were in residents, not staff. Among the 299 nursing home residents, there were four deaths attributed to Covid-19, all in the placebo arm. Among the 41 nursing home residents who tested positive at the study’s beginning, there were four deaths, again in the bamlanivimab arm. In order to get a long duration of effect from the antibodies, Lilly used a dose of 4.2 grams, about six-fold higher than the dose authorized for use in patients with Covid-19. Bamlanivimab is given intravenously. Covid-19 vaccines have already been made available to patients in nursing homes, Skovronsky acknowledged. But he said the antibodies could still be useful if there are outbreaks in places the vaccines have not reached. Eli Lilly will discuss with the FDA whether a new emergency authorization is warranted. Regeneron is conducting its own Covid prevention study in households where one member was infected. Skovronsky said that he also hoped that the results would encourage people who develop Covid to receive antibody treatment. Use of the monoclonal antibodies has been more sporadic than expected, in part because of distribution problems and in part because doctors and patients don’t know to ask for them. The government has purchased large stocks of antibodies from both Lilly and Regeneron; whether the drugs are used more after governments purchase them makes no difference to the companies. Lilly's Official Press Release (Jan. 21, 2021): https://investor.lilly.com/news-releases/news-release-details/lillys-neutralizing-antibody-bamlanivimab-ly-cov555-prevented
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