Eli Lilly announced the initiation of a phase 3 study investigating whether its antibody-based drug LY-CoV555 can help reduce the rate of SARS-CoV-2 infection and COVID-19 in long-term care facilities in the US. The company is developing the neutralizing IgG1 antibody, which is directed against the spike protein of SARS-CoV-2, in collaboration with AbCellera.
Specifically, the BLAZE-2 trial will test whether a single dose of LY-CoV555 cuts the incidence of SARS-CoV-2 infection through 4 weeks, as well as complications of COVID-19 through 8 weeks. It is expected to enroll 2400 residents and staff who live or work at nursing homes that have had a recently diagnosed case of COVID-19 and who are now at heightened risk of exposure. The study is being conducted in partnership with the US National Institute of Allergy and Infectious Diseases (NIAID), along with the COVID-19 Prevention Network (CoVPN) and several long-term care facility networks across the US.
‘Devastating’ impact on nursing homes
“COVID-19 has had a devastating impact on nursing home residents,” commented Daniel Skovronsky, president of Lilly Research Laboratories. “While it’s not easy to conduct clinical trials in this setting, we’re taking on the challenge in an effort to help those who need us the most,” he added.
Eli Lilly said that in a bid to address some of the issues that may arise when running a clinical trial out of a long-term care facility during a pandemic, it has created mobile research units to support the on-site study. These units include a custom retrofitted recreational vehicle to support mobile laboratories and clinical trial material preparation, as well as a trailer truck that will deliver all clinical trial supplies needed to create an on-site infusion clinic. The company said it will deploy its mobile research unit fleet in response to outbreaks of the coronavirus at long-term care facilities across the country.
Other studies under way
The drugmaker stated that dosing in a phase 1 study of LY-CoV555 in hospitalized patients with COVID-19 was recently completed and long-term follow-up is ongoing. Meanwhile, the phase 2 BLAZE-1 trial of the neutralizing antibody in patients with early symptoms of COVID-19 illness is also ongoing. “Based on current trends, enrollment is estimated to be completed in September, with initial data readout soon thereafter followed by full data in the fourth quarter,” the company said, adding that the therapy has so far been well tolerated at all doses tested, with no reported drug-related severe adverse events.
Skovronsky has said that Eli Lilly is looking “to be ready to deliver [the treatment] to patients as quickly as possible, with the goal of having several hundred thousand doses available by the end of the year.”
Last month, Regeneron Pharmaceuticals signed a contract with the US government worth $450 million to manufacture and supply its investigational double antibody cocktail REGN-COV2 for the treatment and prevention of COVID-19.