TORONTO, Jan. 21, 2021 /CNW/ - Bamlanivimab (LY-CoV555) significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities, Eli Lilly and Company (NYSE: LLY) announced. The Phase 3 BLAZE-2 COVID-19 prevention trial – conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH), and the COVID-19 Prevention Network (CoVPN) – enrolled residents and staff at skilled nursing and assisted living facilities, commonly referred to as nursing homes, across the U.S.
The 965 participants who tested negative for the SARS-CoV-2 virus at baseline (299 residents and 666 staff) were included in the analysis of primary and key secondary endpoints for assessing bamlanivimab as a preventative, while the 132 participants (41 residents and 91 staff) who tested positive for the virus at baseline were included in exploratory analyses for assessing bamlanivimab as a treatment, adding to the growing body of evidence for treatment with bamlanivimab. All participants were randomized to receive either 4,200 mg of bamlanivimab or placebo.
After all participants reached 8 weeks of follow-up, there was a significantly lower frequency of occurrences of symptomatic COVID-19 (the primary endpoint) in the bamlanivimab treatment arm versus placebo (odds ratio 0.43, p=0.00021). Results for all key secondary endpoints also reached statistical significance in both the overall and resident populations.
For the pre-specified subgroup of nursing home residents, there was also a significantly lower frequency of symptomatic COVID-19 in those treated with bamlanivimab versus placebo in this important population (odds ratio 0.20; p=0.00026). These results suggest that residents randomized to bamlanivimab have up to an 80 percent lower risk of contracting COVID-19 versus residents in the same facility randomized to placebo.
Results from exploratory analyses of viral load in the treatment group were consistent with previously disclosed data from BLAZE-1, which is evaluating bamlanivimab as an outpatient treatment for recently diagnosed COVID-19.
Among the 299 residents in the prevention group, there were 4 deaths attributed to COVID-19 at the time of death, and all occurred in the placebo arm. There were no COVID-19-attributed deaths in the bamlanivimab arm. Among the 41 residents in the treatment group there were 4 deaths, and all occurred in the placebo arm with none in the bamlanivimab arm. Over the entire trial, there were a total of 16 deaths reported, including deaths not related to COVID-19, and all deaths were among residents (11 deaths in the placebo arm and 5 in the bamlanivimab arm).
"We're very pleased with these results, which showed bamlanivimab helped prevent COVID-19, and substantially reduced symptomatic disease among nursing home staff and residents," said Doron Sagman, M.D., FRCPC, Lilly Canada's senior medical director and vice president of R & D and Medical Affairs. "These data suggest that antibody therapy can help reduce mortality, keep people out of overcrowded hospitals, ease the current strain on the health care system, , and play an important role in helping fight the rapidly increasing burden of this global pandemic."
An independent data and safety monitoring board oversaw the BLAZE-2 trial. In the trial, the safety profile of bamlanivimab was consistent with observations from the Phase 1 and Phase 2 trials. Serious adverse events were reported at a similar frequency in the bamlanivimab and placebo groups. Across multiple clinical trials, Lilly now has collected safety and efficacy data in more than 4,000 patients treated with bamlanivimab, either alone or administered together with another antibody.
"The results of this innovative study further support the belief that bamlanivimab – and potentially other monoclonal antibodies – can reduce symptoms and may even prevent COVID-19," said Myron S. Cohen, M.D., CoVPN co-principal investigator and director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill. "The antiviral activity seen with bamlanivimab treatment emphasizes the importance of early intervention to help counter the devasting impact the virus has had in this vulnerable population and other high-risk patients."
BLAZE-2 is a first-of-its-kind COVID-19 trial designed to evaluate this vulnerable population by addressing the challenging aspects of running a clinical trial in long-term care facilities, which normally do not conduct clinical trials. The study is sponsored by Lilly and conducted in partnership with NIAID, part of the NIH, along with the CoVPN and numerous long-term care facility networks across the country. BLAZE-2 is ongoing as an open-label trial evaluating bamlanivimab alone or administered together with another antibody as a treatment for high-risk individuals (residents and staff) diagnosed with COVID-19 at these long-term care facilities. The full results from BLAZE-2 will be presented at a future medical congress and submitted for publication in a peer-reviewed clinical journal.
Important Information about bamlanivimab
HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS COVID-19 DRUG BASED ON LIMITED CLINICAL TESTING IN HUMANS AND/OR QUALITY INFORMATION.
Bamlanivimab is indicated for: The treatment of adults and pediatric patients 12 years of age or older with mild to moderate COVID-19 who weigh at least 40 kg and who are at high risk of progressing to severe COVID-19 illness and/or hospitalization.
The use of bamlanivimab is permitted under an interim authorization delivered in accordance with section 5 of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization. The interim authorization is associated with Terms and Conditions that need to be met by the sponsor to ascertain the continued quality, safety and efficacy of the product. For further information on authorization under this pathway, please refer to Health Canada's IO Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
Healthcare providers should review the product monograph for bamlanivimab, the Patient Medication Information on bamlanivimab, and the Dear HCP Letter on the use of bamlanivimab with English-only labels. Also available is the Bamlanivimab Playbook: information for provincial, territorial and local public health programs in planning and implementing the use of bamlanivimab in response to COVID-19 (December 2020).
Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.
Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.
Bamlanivimab is authorized in the U.S. for the treatment of 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.
BLAZE-2, (NCT04497987) is a randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of bamlanivimab 4200 mg versus placebo for the prevention of SARS-CoV-2 infection and COVID-19 in skilled nursing and assisted living facility residents and staff. To be eligible, there must be at least one confirmed case of SARS-CoV-2 infection among residents or facility staff based on a sample collection no more than seven days prior to randomization.
The primary outcome measure for the completed arms of the BLAZE-2 trial was cumulative incidence of COVID-19 defined as the detection of SARS-CoV-2 by RT-PCR and mild or worse disease severity within 21 days of detection. Additional endpoints include cumulative incidence of SARS-CoV-2 infection, moderate or worse disease severity within 21 days of detection, as well as safety.
Residents and staff were tested for SARS-CoV-2 weekly – whether or not they exhibited symptoms – providing robust surveillance data regarding the impact of bamlanivimab on infection rates and symptomatic COVID-19 diagnoses in this population.
The study is ongoing as an open-label trial evaluating bamlanivimab alone or administered together with another antibody as a treatment for high-risk individuals (residents and staff) diagnosed with COVID-19 at long-term care facilities.
Across all treatment arms, the trial will enroll up to 5,000 participants.
About Lilly's COVID-19 Efforts
Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with partner companies to discover novel antibody treatments for COVID-19. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19.
About Lilly Canada
Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.
Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.
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Lilly Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about bamlanivimab (LY-CoV555) as a potential treatment for patients with or at risk of infection from COVID-19, as well as its supply, and reflects Lilly's current beliefs. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that bamlanivimab will prove to be a safe and effective treatment or preventative for COVID-19, that bamlanivimab will receive regulatory approvals or additional authorizations, or that we can provide an adequate supply of bamlanivimab in all circumstances. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
SOURCE Eli Lilly Canada Inc.
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