Lilly slashes clinical trial activities in response to COVID-19

Eli Lilly is slashing its clinical trial activities in response to the COVID-19 pandemic. With the novel coronavirus putting healthcare systems under tremendous strain, Lilly has decided to delay most trial starts and pause enrollment in most ongoing studies.

The SARS-CoV-2 pandemic forced companies including Addex Therapeutics, Iveric Bio and Provention Bio to rethink clinical trial programs last week. Now, Lilly has joined the list of companies to change up their activities in light of the effect of the pandemic on the ability of study sites to safely enroll and dose subjects.

Lilly is holding off on starting most new studies for now and hitting pause on the recruitment of new patients into its existing trials. The Big Pharma is asking subjects already enrolled in trials to carry on following study protocols, although lockdowns could impede their ability to comply with the request. 

As Lilly’s chief medical officer Tim Garnett said in a statement, the approach is intended to ease the burden on healthcare systems while avoiding the harms associated with a comprehensive shutdown of all active studies. 

“Lilly recognizes 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. Therefore, we will maintain ongoing studies, but with study-by-study consideration,” Garnett said. 

As it stands, Lilly expects to hit most of its previously disclosed timelines for active late-phase trials. The exception is the clutch of clinical trials Lilly is running to assess anti-IL-23 antibody mirikizumab in gastrointestinal indications. Lilly is testing the drug in a handful of phase 3 trials in Crohn’s disease and ulcerative colitis that have primary completion dates ranging from September 2020 to late 2023, according to their listings on Lilly is yet to say how those targets will change.

While mirikizumab is the only confirmed delay, there is scope for COVID-19 to push back Lilly’s plans to gather data on other key assets. For example, Lilly has initiated four phase 3 trials of tirzepatide over the past eight months and was poised to start a fifth next week. 

The FDA provided guidance last week that could help some studies keep going despite disruption caused by the coronavirus, for example by making greater use of the technologies and processes that enable virtual clinical trials. However, in-person interaction is essential to some studies, and moving to new ways of working mid-study could be challenging.