Eli Lilly pauses enrolment in ongoing trials, delays new study starts citing strain coronavirus placing on healthcare system

Eli Lilly said Monday that as a result of the COVID-19 pandemic, it will postpone most new study starts, and temporarily suspend recruiting new patients or healthy volunteers in most of its ongoing trials. Chief medical officer Tim Garnett remarked that with the move, "we hope to ease the burden on participating healthcare facilities and allow physicians to focus more of their efforts on combatting COVID-19."

Garnett also said given that "for patients already enrolled in clinical trials, discontinuation would disrupt their treatment and potentially diminish the societal value of the research information to which they are contributing…we will maintain ongoing studies, but with study-by-study consideration." It noted that those already enrolled in ongoing clinical trials will continue following study protocols.

The company added that in a bid to alleviate some of the pressure that the pandemic has placed on the healthcare system, "we have repurposed our laboratories to conduct diagnostic testing for patients and we are researching potential therapeutics." Earlier this month, it entered into a partnership with AbCellera to co-develop antibody products for the treatment and prevention of COVID-19.

Meanwhile, Eli Lilly said it does not expect adjustments to previously communicated timelines for ongoing late-stage studies, except for the gastrointestinal indications for mirikizumab, an experimental p19-directed IL-23 antibody. The company also currently does not anticipate a change to its 2020 financial guidance as a result of COVID-19, while it "continues to take the steps necessary to maintain the supply of all of its medicines around the world."

The FDA last week recommended some alternatives regarding the conduct of ongoing clinical trials during the pandemic, including switching to virtual patient visits instead of in-person monitoring in situations where trial participants may no longer have access to the investigational product or the investigational site.

Last week, IVERIC bio delayed enrolment in a trial of the complement C5 inhibitor Zimura (avacincaptad pegol), which is under development as a treatment for geographic atrophy secondary to dry age-related macular degeneration. The company said its decision was made "in light of the COVID-19 pandemic and out of an abundance of caution for the safety and well-being of our elderly patients and participating physicians and their staffs."

The news came shortly after Provention Bio paused a study of PRV-031, also known as teplizumab, for similar reasons, but allowed trial participants to complete their course. The anti-CD3 monoclonal antibody is being evaluated as a treatment for patients with newly diagnosed type 1 diabetes. Provention Bio noted that it remains on track to complete its rolling FDA submission for the drug in the fourth quarter of 2020 to prevent or delay type 1 diabetes in at-risk individuals.

For related analysis, see ViewPoints: Impact of COVID-19 on clinical trial enrolment comes into view.

 

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