Bamlanivimab COVID-19 Antibody Treatment Description
Eli Lilly's Bamlanivimab (LY-CoV555) is an investigational neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein SARS-CoV-2 coronavirus. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing and treating COVID-19.
Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies to prevent and treat COVID-19. Lilly scientists rapidly developed the antibody in less than three months after being discovered by AbCellera and tested by the scientists at the NIAID Vaccine Research Center.
Bamlanivimab is authorized in the U.S. to treat mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.
In addition to Bamlanivimab, a second Lilly antibody, LY-CoV016, which binds a different epitope in the SARS-CoV-2 spike region, has been added BLAZE-1 clinical trial. Etesevimab (LY-CoV016, also known as JS016) is a recombinant fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor-binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function.
On February 23, 2021, the U.S. NIH updated the COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of the Bamlanivimab plus Etesevimab Combination for the Treatment of COVID-19. Based on the available evidence, the Panel recommends using bamlanivimab 700 mg plus etesevimab 1,400 mg to treat outpatients with mild to moderate COVID-19 who are at high risk of clinical progression as defined by the EUA criteria.
On March 24, 2021, the NIH published an update on COVID-19 variants and the impact on the future distribution of bamlanivimab.
Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories, stated on March 29, 2021, "The reduction in persistently high viral load is an important virology endpoint that was demonstrated in Lilly's Phase 2 BLAZE-1 trial, and subsequently validated in the Phase 3 trial, to be strongly correlated with the clinical outcome of COVID-19 related hospitalizations and deaths in high-risk patients. These virology data support our belief that bamlanivimab and VIR-7831 together could be a promising option for COVID-19 treatment."
Etesevimab Monoclonal Neutralizing Antibody
Etesevimab (LY-CoV016, JS016) is a recombinant fully human monoclonal neutralizing antibody, specifically binds to the SARS-CoV-2 surface spike protein receptor-binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function.
Eli Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science. Junshi Biosciences has completed a similar Phase 1 study in healthy volunteers in China and has initiated Phase 1b/2 trials in COVID-19 patients globally.
Lilly has completed a Phase 1 study of etesevimab in healthy U.S. volunteers to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity. A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1) is ongoing.
The U.S. FDA published a revised Fact Sheet on March 20, 2021.
Bamlanivimab COVID-19 Antibody Treatment History
On November 9, 2020, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the bamlanivimab to treat mild-to-moderate COVID-19 in adult and pediatric patients. While this investigational therapy's safety and effectiveness continue to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.
Previously, on October 1, 2020, a non-peer-reviewed study found 'In a rhesus macaque challenge model, prophylaxis Bamlanivimab doses as low as 2.5 mg/kg reduced viral replication in the upper and lower respiratory tract. These data demonstrate that high-throughput screening can lead to the identification of a potent antiviral antibody that protects against SARS-CoV-2 infection.'
On October 14, 2020, Lilly stated the National Institute of Allergy and Infectious Diseases (NIAID) Decision to Pause Enrollment in ACTIV-3 Clinical Trial: 'Lilly continued to be in communication with the trial sponsor regarding the recommendation from the independent data safety monitoring board (DSMB) of the ACTIV-3 clinical trial to pause enrollment of the study. ACTIV-3, which evaluates Lilly’s investigational neutralizing antibody bamlanivimab (LY-CoV555) as a treatment for COVID-19 in hospitalized patients, is sponsored by the NIAID, part of the National Institutes of Health (NIH).
Lilly continued stating: 'At this time, only the DSMB has reviewed the data from the trial, and NIH leadership and Lilly remain blinded to the ongoing trial results. Lilly trusts the judgment of the independent DSMB and supports its decisions to exercise caution in ensuring the safety of the patients participating in this study. Importantly, the DSMB also considered the impact of the ACTIV-3 study pause on ACTIV-2 and did not recommend any changes to that study’s design or enrollment.'
On November 9, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to make bamlanivimab available to treat nonhospitalized patients with mild to moderate COVID-19 high risk for progressing to severe disease and/or hospitalization. The issuance of a EUA does not constitute FDA approval of a product. The COVID-19 Treatment Guidelines Panel reviewed the available evidence from the published data on bamlanivimab for the treatment for COVID-19 and the FDA fact sheet that supported the EUA, said the NIH.
The company announced a new purchase agreement with the US government on December 2, 2020, for $812.5 million. The bamlanivimab doses will be delivered through January 31, 2021, with at least 350,000 additional doses given in December 2020. David A. Ricks, Lilly's chairman, and CEO stated in a press release: "We are proud of our work to deploy significant manufacturing capacity and remain committed to enabling widespread and equitable access to bamlanivimab. The U.S. government's effort to allocate bamlanivimab around the country is critical to ensuring it reaches patients who need it the most."
On January 26, 2021, Lilly announced new data show treatment with the neutralizing antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) the risk of COVID-19 hospitalizations and death by 70%. "These exciting results, which replicate positive Phase 2 data in a much larger set of patients, add valuable clinical evidence about the role neutralizing antibodies can play in fighting this pandemic. While the preliminary nature of Phase 2 results from COVID-19 neutralizing monoclonal antibodies may have limited acceptance of treatment, these Phase 3 data further strengthen the available evidence," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories, in a press statement.
The U.S. Food and Drug Administration (FDA) announced the granting of an Emergency Use Authorization (EUA) on February 9, 2021, for Lilly's investigational bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together. This therapy is authorized to treat mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization.
This EUA states Bamlanivimab and etesevimab should be administered together via a single intravenous infusion as soon as possible after a positive COVID-19 test and within 10 days of symptom onset. The FDA has also authorized infusion times for bamlanivimab alone and bamlanivimab and etesevimab together to be as short as 16 or 21 minutes, respectively – a significant reduction from the previously authorized time of 60 minutes.
Based in Indiana, Lilly is a global healthcare leader who unites caring with discovery to create medicines that make life better for people worldwide. To learn more about Lilly, please visit us at www.lilly.com.
Bamlanivimab COVID-19 Antibody Treatment Indication
Bamlanivimab (LY-CoV555) is indicated to prevent or mitigate the progression of COVID-19 infection caused by the SARS-CoV-2 coronavirus. As of November 9, 2020, Bamlanivimab was authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older, weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset, says Lilly.
The U.S. FDA EAU includes 65 years of age or older or certain chronic medical conditions. Bamlanivimab is not authorized for hospitalized patients due to COVID-19 or require oxygen therapy due to COVID-19. Healthcare providers should review the Fact Sheet for information on the authorized use of bamlanivimab and mandatory requirements of the EUA.
On March 2, 2021, the FDA published an update to Emergency Use Authorization 090.
Bamlanivimab COVID-19 Treatment Adverse Events
Adverse events reported in at least 1% of BLAZE-1 clinical trial participants on bamlanivimab 700 mg and placebo were Nausea (3% vs 4%), Diarrhea (1% vs 5%), Dizziness (3% vs 2%), Headache (3% vs 2%), Pruritus (2% vs 1%) and Vomiting (1% vs 3%).
Bamlanivimab COVID-19 Antibody Treatment Safety Information
There are limited clinical data available for bamlanivimab. Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab use. Infusion-related reactions have been observed with the administration of bamlanivimab.
There is a potential for severe hypersensitivity reaction, including anaphylaxis, with the administration of bamlanivimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care.
There are insufficient data on the use of bamlanivimab during pregnancy. Bamlanivimab should only be used during pregnancy if the potential benefit outweighs the mother and fetus's potential risk.
There are no available data on the presence of bamlanivimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.
Bamlanivimab COVID-19 Antibody Treatment Guidelines
Eli Lilly says, 'If you’ve recently been diagnosed with COVID-19, you may have a new treatment option: bamlanivimab (bam-la-NIV-i-mab). The research so far shows that taking this drug may help limit the number of viruses in the body for certain people. This may help their symptoms improve sooner — and they may be less likely to need to go to the hospital. But bamlanivimab is a new drug that’s still being studied, so there’s a lot that scientists don’t know about the benefits and risks. Together, you and your doctor can decide if this treatment is right for you.'
The revised NIH COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of Bamlanivimab for the Treatment of COVID-19 indicates the optimal dose of bamlanivimab plus etesevimab for the treatment of COVID-19 has not yet been established, and the dose currently recommended by the EUA may be revised as data from clinical trials emerge. The dose authorized in the EUA is bamlanivimab 700 mg plus etesevimab 1,400 mg administered together in a single infusion, which is different from the dose (bamlanivimab 2,800 mg plus etesevimab 2,800 mg, also administered as a single infusion) used in the BLAZE-1 Phase 3 study.
Bamlanivimab COVID-19 Antibody Treatment News
April 8, 2021 - The U.S. NIH announced data are emerging on the currently available anti-SARS-CoV-2 monoclonal antibodies, including preliminary data from a Phase 3 trial of casirivimab plus imdevimab and on the in vitro susceptibility of SARS-CoV-2 variants to anti-SARS-CoV-2 monoclonal antibodies. After reviewing the available data, the COVID-19 Treatment Guidelines Panel (the Panel) has updated its recommendations on the use of anti-SARS-CoV-2 monoclonal antibodies in outpatients with mild to moderate COVID-19 who are at high risk of disease progression. Also, the Panel notes that, because of an increasing number of reports of variants that are resistant to bamlanivimab alone, this product will no longer be distributed by the U.S. government.
March 29, 2021 - Eli Lilly and Company, Vir Biotechnology, Inc., and GlaxoSmithKline plc announced topline data from the expanded Phase 2 BLAZE-4 trial studying low-risk adult patients with mild to moderate COVID-19. Results showed that investigational bamlanivimab (LY-CoV555) 700 mg co-administered with VIR-7831 (also known as GSK4182136) 500 mg demonstrated a 70 percent (p<0.001) relative reduction in persistently high viral load (> 5.27; cycle threshold value < 27.5) at day 7 compared to placebo, meeting the primary endpoint. Also, bamlanivimab administered with VIR-7831 demonstrated a statistically significant reduction compared to placebo in the key virologic secondary endpoints of mean change from baseline to days 3, 5, and 7 in the SARS-CoV-2 virus viral load.
March 19, 2021 - The U.S. FDA posted a new Fact Sheet.
March 17, 2021 - Endpoint News reported the US government is no longer distributing Eli Lilly’s bamlanivimab into California, Arizona, and Nevada because of the prevalence of a viral variant that is not susceptible to the monoclonal antibody, FDA acting commissioner Janet Woodcock announced in a webinar with the AMA.
March 11, 2021 - The EMA’s human medicines committee has started a ‘rolling review’ of data on the antibodies bamlanivimab and etesemivab, which are being developed by Indiana-based Eli Lilly and Company to be used in combination for the treatment of COVID-19. The review will also look at bamlanivimab used alone.
March 10, 2021 - Eli Lilly announced new data from the BLAZE-1 Phase 3 study, demonstrating bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together significantly reduced COVID-19 related hospitalizations and deaths in high-risk patients recently diagnosed with COVID-19. These results provide additional efficacy and safety data that support the use of the dose recently granted both Emergency Use Authorization by the U.S. Food and Drug Administration and a positive scientific opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use.
March 5, 2021 - Eli Lilly and Company announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab. The opinion advises that bamlanivimab alone and bamlanivimab administered together with etesevimab can be used to treat confirmed COVID-19 in patients aged 12 years and older who do not require supplemental oxygen for COVID-19 and who are at high risk of progressing to severe COVID-19.
February 26, 2021 - Eli Lilly and Company announced the U.S. government has agreed to purchase a minimum of 100,000 doses of bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together; Bamlanivimab and etesevimab together recently received emergency use authorization for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization. Additionally, the National Institutes of Health recently updated the COVID-19 Treatment Guidelines to recommend using bamlanivimab plus etesevimab to treat outpatients with mild to moderate COVID-19 who are at high risk of clinical progression.
February 23, 2021 - The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of the Bamlanivimab Plus Etesevimab Combination for the Treatment of COVID-19: Bamlanivimab and etesevimab are neutralizing monoclonal antibodies that bind to different but overlapping epitopes in the receptor-binding domain of the spike protein of the SARS-CoV-2 coronavirus. The bamlanivimab plus etesevimab combination blocks SARS-CoV-2 entry into host cells and is being evaluated for the treatment of COVID-19.
February 17, 2021 - LETTER TO THE EDITOR published by Wiley: Bamlanivimab to treat COVID‐19 in solid organ transplant recipients: An early single‐center experience. In this study, following the administration of Bamlanivimab to solid organ transplant patients diagnosed with mild‐moderate COVID‐19 in a non‐hospitalized setting, no patient experienced symptom worsening or required hospitalization.
February 9, 2021 - The U.S. FDA issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The EUA use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions. More than 250,000 doses were manufactured throughout Q1 2021, up to 1 million doses by mid-2021.
February 4, 2021 - The European Medicine Agency announced the human medicines committee is reviewing available data on the use of the monoclonal antibodies casirivimab, imdevimab, bamlanivimab, and etesevimab to treat patients with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19. The committee will carry out two separate reviews: the casirivimab/imdevimab combination and another for bamlanivimab/etesevimab.
January 27, 2021 - Eli Lilly and Company, Vir Biotechnology, Inc., and GlaxoSmithKline plc announced a collaboration to evaluate a combination of two COVID-19 therapies in low-risk patients with mild to moderate COVID-19. Lilly has expanded its ongoing BLAZE-4 trial to evaluate the administration of bamlanivimab (LY-CoV555) 700mg with VIR-7831 (also known as GSK4182136) 500mg, two neutralizing antibodies that bind to different epitopes of the SARS-CoV-2 spike protein. This unique collaboration marks the first time that monoclonal antibodies from separate companies will be brought together to explore potential outcomes.
January 26, 2021 - Eli Lilly announced Bamlanivimab (LY-CoV555) 2800 mg and etesevimab (LY-CoV016) 2800 mg together significantly reduced COVID-19-related hospitalizations and deaths in high-risk patients recently diagnosed with COVID-19. Across 1,035 patients, there were 11 events (2.1 percent) in patients taking therapy and 36 events (7.0 percent) in patients taking placebo, representing a 70 percent risk reduction (p= 0.0004). Bamlanivimab and etesevimab also demonstrated statistically significant improvements on all key secondary endpoints, providing strong evidence that the therapy reduced viral load and accelerated symptom resolution.
January 21, 2021 - Eli Lilly and Company's Bamlanivimab (LY-CoV555) significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities, according to the Phase 3 BLAZE-2 COVID-19 prevention trial. After all of the study participants reached 8 weeks of follow-up, there was a significantly lower frequency of symptomatic COVID-19 (the primary endpoint) in the bamlanivimab treatment arm versus placebo (odds ratio 0.43, p=0.00021). All key secondary endpoints also reached statistical significance in both the overall and resident populations.
January 21, 2021 - JAMA Network Original Investigation - Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19. A Randomized Clinical Trial Conclusions and Relevance: 'Among nonhospitalized patients with mild to moderate COVID-19 illness, treatment with bamlanivimab and etesevimab, compared with placebo, was associated with a statistically significant reduction in SARS-CoV-2 viral load at day 11. No significant difference in viral load reduction was observed for bamlanivimab monotherapy. Further ongoing clinical trials will focus on assessing the clinical benefit of antispike neutralizing antibodies in patients with COVID-19 as a primary endpoint.'
December 28, 2020 - Governor Greg Abbott and the Texas Department of State Health Services are alerting nursing facilities to the availability of monoclonal antibody therapies that can be used to treat residents who have been diagnosed with COVID-19. Commissioner John Hellerstedt, MD, urges facility administrators to work with their medical directors and treating physicians to consider the use of monoclonal antibodies whenever appropriate. These therapeutics have shown promise in reducing hospital admissions for patients who have been diagnosed with the disease, have a mild or moderate illness and are in a high-risk group for developing severe disease.
December 18, 2020 - Eli Lilly and Company announced plans to begin a new pragmatic study of bamlanivimab (LY-CoV555) in high-risk patients with COVID-19, collaborating with major local institutions in the state of New Mexico. Conducting the study in New Mexico will allow for collecting data on the effectiveness and safety of bamlanivimab in a real-world setting that includes a diverse population and spans both rural and urban environments.
December 11, 2020 - JAMA article: he investigational neutralizing IgG1 monoclonal antibody bamlanivimab (LY-CoV555; Lilly) has been granted an FDA Emergency Use Authorization (EUA) for treatment of recently diagnosed mild to moderate COVID-19 in patients who are ≥12 years old, weigh at least 40 kg, and are at high risk for progressing to severe disease and/or hospitalization.
December 4, 2020 - Eli Lilly and UnitedHealth Group announced a partnership to conduct a pragmatic study of bamlanivimab (LY-CoV555) in high-risk, COVID-19 infected individuals. The study will identify and treat a large, diverse population of high-risk individuals for COVID-19 with bamlanivimab under real-world conditions to reduce the severity of illness and hospitalizations. It will draw upon both UnitedHealth Group's UnitedHealthcare health benefits business and its Optum health services business to detect and treat high-risk symptomatic patients who test positive for COVID-19, including daily symptom tracking, in-home SARS-CoV-2 testing, and in-home infusion services.
December 2, 2020 - The U.S. government has purchased 650,000 additional doses of the neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. The doses will be delivered through January 31, 2021, with at least 350,000 extra doses delivered in December 2020. Bamlanivimab recently received emergency use authorization to treat mild to moderate COVID-19 in patients at high risk for progressing to severe COVID-19 and/or hospitalization. This purchase brings the total doses purchased by the U.S. government to 950,000. As previously announced by the U.S. government, Americans will have no out-of-pocket costs for the medicine, although healthcare facilities may charge a fee for the product's administration.
November 24, 2020 - 1st patient receiving Covid-19 antibody infusion at El Paso Convention Center hospital announced. The alternate care site was provided with 1,000 doses of bamlanivimab, a monoclonal antibody therapy created by Eli Lilly & Company recently approved for emergency use by the FDA.
November 20, 2020 - Health Canada granted authorization under the Interim Order Respecting the Importation, Sale, and Advertising of Drugs for Use concerning COVID-19 for the use of bamlanivimab (LY-CoV555) as a treatment for adults and pediatric patients 12 years of age or older with mild to moderate COVID-19 who weigh at least 40 kg and are at high risk of progressing to severe COVID-19 illness and/or hospitalization. This authorization, the second authorization around the world for bamlanivimab, is based on data from BLAZE-1, a randomized, double-blind placebo-controlled phase 2 study in patients with recently diagnosed mild to moderate COVID-19.
November 19, 2020 - Texas Governor Greg Abbott updated the distribution of bamlanivimab, the Eli Lilly & Company monoclonal antibody therapy for COVID-19. The Texas Department of State Health Services has allocated this initial shipment of bamlanivimab to acute care hospitals across Texas.
November 13, 2020 - A new study in Italy found Baricitinib as possessing anti-viral and anti-cytokine efficacy. This limited study showed a 71% (95% CI 0.15-0.58) mortality benefit in 83 patients with moderate-severe SARS-CoV-2 pneumonia, with few drug-induced adverse events, including a large elderly cohort (median age 81 years).
November 9, 2020 - Eli Lilly announced the U.S. FDA granted Emergency Use Authorization for the investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. The authorization allows for the distribution and emergency use of bamlanivimab administered via a single intravenous infusion.
October 28, 2020 - Eli Lilly and Company announced an initial agreement with the U.S. government to supply 300,000 vials of bamlanivimab (LY-CoV555) 700 mg, an investigational neutralizing antibody, for $375 million. The initial agreement is for delivery over the two months following authorization and also provides the option for the U.S. government to purchase up to an additional 650,000 vials through June 30, 2021.
October 26, 2020 - The ACTIV-3 clinical trial is being run by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). It is the only study evaluating the efficacy of bamlanivimab in hospitalized COVID-19 patients. Based on an updated dataset from the trial reviewed on October 26, no additional COVID-19 patients in this hospitalized setting will receive bamlanivimab. This recommendation was based on trial data suggesting that bamlanivimab is unlikely to help hospitalized COVID-19 patients recover from this advanced stage of their disease. In this updated dataset, differences in safety outcomes between the groups were not significant.
October 14, 2020 - Lilly announced it continues to communicate with the trial sponsor regarding the recommendation from the independent data safety monitoring board (DSMB) of the ACTIV-3 clinical trial to pause the study's enrollment. ACTIV-3, which evaluates Lilly’s investigational neutralizing antibody bamlanivimab (LY-CoV555) as a treatment for COVID-19 in hospitalized patients, is sponsored by the National Institute Allergy and Infectious Diseases, part of the National Institutes of Health. At this time, only the DSMB has reviewed the data from the trial, and NIH leadership and Lilly remain blinded to the ongoing trial results. Lilly trusts the judgment of the independent DSMB and supports its decisions to exercise caution in ensuring the safety of the patients participating in this study.
October 13, 2020 - Eli Lilly and Co said that the government-sponsored clinical trial of its COVID-19 antibody treatment had been paused because of a safety concern.
October 8, 2020 - Junshi Biosciences announced that its global partner Eli Lilly and Company announced positive interim data on combination therapy with neutralizing antibodies JS016 (LY-CoV016) LY-CoV555 in recently diagnosed patients with mild-to-moderate COVID-19 illness. Lilly intends to submit a request for Emergency Use Authorization (EUA) for the combination therapy in patients with mild-to-moderate COVID-19 in November 2020.
October 7, 2020 - Lilly provides a comprehensive update on the progress of SARS-CoV-2 neutralizing antibody programs.
October 1, 2020 - Non-peer-reviewed study: LY-CoV555, a rapidly isolated potent neutralizing antibody, protects in a non-human primate model of SARS-CoV-2 infection.
September 16, 2020 - Lilly announced proof of concept data from an interim analysis of the BLAZE-1 clinical trial, showing a reduced hospitalization rate for patients treated with LY-CoV555.
August 3, 2020 - Lilly Initiates Phase 3 Trial of LY-CoV555 for Prevention of COVID-19 at Long-Term Care Facilities in Partnership with the National Institute of Allergy and Infectious Diseases (NIAID).
June 1, 2020 - Eli Lilly and Company announced patients had been dosed in the world's first study of a potential antibody treatment designed to fight COVID-19.
Bamlanivimab COVID-19 Antibody Treatment Clinical Trials
Clinical Trial NCT04501978: ACTIV-3: Therapeutics for Inpatients With COVID-19 (TICO). Last Update Posted: February 23, 2021. Phase 3 randomized, controlled trial is known as ACTIV-3, and as a “master protocol,” it is designed to expand to test multiple different kinds of monoclonal antibody treatments. It also can enroll additional volunteers in the middle of the trial if a specific investigational treatment shows promise.
Clinical Trial NCT04411628: A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19. Last Update Posted: October 30, 2020. The purpose of this study is to test the safety and tolerability of LY3819253 when it is given by injection into a vein to participants hospitalized with COVID-19.
Clinical Trial NCT04427501: A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness (BLAZE-1). Last Update Posted: December 19, 2020. The purpose of this study is to measure how well LY3819253 and LY3832479 work against the virus that causes COVID-19. LY3819253 and LY3832479 will be given to participants with early symptoms of COVID-19 via an injection into a vein.
Clinical Trial NCT04497987: A Study of LY3819253 (LY-CoV555) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff (BLAZE-2). Last Update Posted: November 10, 2020. The purpose of this study is to evaluate whether LY3819253 prevents severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease - 2019 (COVID-19) in facility staff and residents in contracted skilled nursing and assisted living facility networks with a high risk of SARS-CoV-2 exposure.