Company Announcements

New data show treatment with Lilly's neutralizing antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) together reduced risk of COVID-19 hospitalizations and death by 70 per cent

  • BLAZE-1 trial met primary endpoint and key secondary endpoints with high statistical significance
  • Results from more than 1,000 high-risk patients were consistent with previous data
  • Findings from BLAZE-4 trial provide data on lower doses of bamlanivimab and etesevimab together
  • Media and investor call "SARS-CoV-2 Neutralizing Antibody Program Update" to be held at noon ESTJanuary 26; link for joining live or for subsequent replay available here

TORONTO, Jan. 26, 2021 /CNW/ - Bamlanivimab (LY-CoV555) 2800 mg and etesevimab (LY-CoV016) 2800 mg together significantly reduced COVID-19-related hospitalizations and deaths (collectively, "events") in high-risk patients recently diagnosed with COVID-19, meeting the primary endpoint of the Phase 3 BLAZE-1 trial, Eli Lilly and Company (NYSE: LLY) announced. 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 per cent risk reduction (p= 0.0004). There were 10 deaths total, all of which occurred in patients taking placebo, and no deaths in patients taking bamlanivimab and etesevimab together.

Bamlanivimab and etesevimab together also demonstrated statistically significant improvements on all key secondary endpoints, providing strong evidence that the therapy reduced viral load and accelerated symptom resolution.

"These data show that treatment with bamlanivimab and etesevimab together may be effective in reducing symptoms, reducing viral load, and decreasing the risk of hospitalization and death in patients recently diagnosed with mild to moderate COVID-19," said Doron Sagman, M.D., FRCPC, Lilly Canada's senior medical director and vice president of R & D and medical affairs. "These data, which replicate the positive Phase 2 data, increase our confidence in the use of neutralizing antibodies as an important treatment to help fight the rapidly increasing burden of this global pandemic, and we look forward to seeing them put to use for Canadian patients in need."

"Notably, the 70 per cent decrease in risk of hospitalizations or death seen in this Phase 3 trial of bamlanivimab and etesevimab together is consistent with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone in the Phase 2 trial," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories.

In the trial, the safety profile of bamlanivimab and etesevimab together was consistent with observations from other Phase 1, Phase 2 and Phase 3 trials evaluating these antibodies. Serious adverse events were reported at a similar frequency in the group receiving bamlanivimab and etesevimab together and the group receiving placebo. Across multiple clinical trials, Lilly has collected safety and efficacy data in more than 4,000 participants treated with Lilly's neutralizing antibodies, either bamlanivimab alone or bamlanivimab and etesevimab together.

Bamlanivimab is authorized for use in the treatment of mild- to moderate COVID-19 in high-risk patients under Health Canada's Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19, and it has also been authorized for use in several other countries.

BLAZE-4

Additionally, initial results from the ongoing BLAZE-4 trial provide viral load and pharmacodynamic/pharmacokinetic data which demonstrated lower doses, including bamlanivimab 700 mg and etesevimab 1400 mg together, are similar to bamlanivimab 2800 mg and etesevimab 2800 mg together. Lilly plans to explore even lower doses of bamlanivimab and etesevimab together, as lower doses can maximize available supply to treat more patients, allow potential for subcutaneous dosing, and potentially reduce the burden on healthcare system and patients through reduced infusion times.

Lilly has a robust global supply chain in place to produce its neutralizing antibodies, with numerous manufacturing sites worldwide, and the supply is expected to increase substantially in 2021. Lilly continues to accelerate the manufacturing of etesevimab in collaboration with Amgen, to provide up to 1 million doses of etesevimab for administration with bamlanivimab by mid-2021 – including more than 250,000 doses in the first quarter – for use around the world.

Investors, media and the general public are invited to a conference call where Lilly will provide more data and discuss Lilly's SARS-CoV-2-neutralizing antibody program. The webcast information is available here. Participants may join live at noon EST on January 26 or, after that time may access a replay of the event at that same link.

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 COVID19 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'sIO 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).

About bamlanivimab  

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.

About etesevimab

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. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science (IMCAS). Junshi Biosciences leads development in Greater China, while Lilly leads development in the rest of the world.

Lilly has successfully completed a Phase 1 study (NCT04441931) 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, NCT04427501) is ongoing. 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.

About BLAZE-1

BLAZE-1 (NCT04427501) is a randomized, double-blind, placebo-controlled Phase 2/3 study designed to assess the efficacy and safety of bamlanivimab alone or  bamlanivimab and etesevimab together 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.

In the Phase 2 portion of BLAZE-1, cohorts of mild to moderate recently diagnosed COVID-19 patients, were randomized to one of three doses of bamlanivimab (700 mg, 2800 mg, and 7000 mg), bamlanivimab 2800 mg plus etesevimab 2800 mg, or placebo. Results from the Phase 2 cohorts of BLAZE-1 were published in the New England Journal of Medicine and The Journal of the American Medical Association.

In the Phase 3 portion of BLAZE-1, the combination therapy arms enrolled mild to moderate, recently diagnosed COVID-19 patients who are at high risk for progressing to severe COVID-19 and/or hospitalization, studying bamlanivimab 2800 mg plus etesevimab 2800 mg versus placebo. The primary outcome measure for the Phase 3 portion of the BLAZE-1 trial was the percentage of participants who experience COVID-related hospitalizations or death from any cause by day 29. The key secondary endpoints were change from baseline to day 7 in SARS-CoV-2 viral load, persistently high SARS-CoV2 viral load on day 7, time to sustained symptom resolution, and COVID-related hospitalization, ER visit or death from any cause from baseline by day 29. Additional endpoints include change from baseline in viral load at other time points, symptom improvement, symptom resolution, as well as safety.

The study is ongoing with additional treatment arms. Across all treatment arms, the trial will enroll up to 3,300 participants.

About BLAZE-4

BLAZE-4 (NCT04634409) is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of bamlanivimab alone, and bamlanivimab and etesevimab together, at various doses, versus placebo for the treatment of symptomatic COVID-19 in the outpatient setting. Across all treatment arms, the trial will enroll an estimated 1,000 participants in the United States and Puerto Rico.

The primary outcome measure is percentage of participants who have a viral load greater than 5.27 at day 7. Additional endpoints include change from baseline to Day 7 in SARS-CoV-2 viral load, percentage of participants who experience COVID-related hospitalization, ER visit or death from baseline through Day 29, as well as safety.

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.

For our perspective on issues in healthcare and innovation, follow us on twitter @LillyPadCA  

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.