This morning, the Indianapolis-based company said it will delay most new study starts and pause enrollment in most ongoing studies in light of the COVID-19 pandemic.
Days after Eli Lilly announced it will partner with the state of Indiana to accelerate testing for COVID-19 in that state, the company said the pandemic is forcing it to pause enrollment and delay the start of new studies.
This morning, the Indianapolis-based company said it will delay most new study starts and pause enrollment in most ongoing studies in light of the COVID-19 pandemic. Lilly is continuing ongoing clinical trials for patients who are already enrolled, the company said.
Lilly said the novel coronavirus, which was declared a pandemic by the World Health Organization two weeks ago, has “substantially impacted the global healthcare delivery system” and forced systems to adapt to treat an influx of patients. As a result, many of the healthcare systems have had to restructure their services, which has caused a de-prioritization of some clinical trials, particularly those that are new or in the early stages of enrollment.
Tim Garnett, chief medical officer for Eli Lilly, said the company is attempting to “alleviate some of the pressure that the global COVID-19 pandemic has placed on our healthcare system” through repurposing of its own laboratories to conduct diagnostics for the virus and research into new treatments for disease.
“In the interest of helping to ensure patient safety and minimizing further stress on the system, Lilly has also decided to take several proactive steps in regard to our clinical trial activities around the world during the COVID-19 pandemic. By delaying most new study starts and pausing enrollment of new patients or healthy volunteers in most ongoing studies, we hope to ease the burden on participating healthcare facilities and allow physicians to focus more of their efforts on combatting COVID-19,” Garnett said in a statement.
The company’s decision will impact new trials, or those enrolling. Garnett said patients who are already receiving treatment in ongoing clinical trials will continue to do so. Discontinuation of the administration of experimental drugs to those patients would “disrupt their treatment and potentially diminish the societal value of the research information to which they are contributing. While Lilly intends to maintain its ongoing trials, Garnett said they will be done so with a “study-by-study consideration.”
Lilly does not anticipate any change to its financial guidance as a result of COVID-19, the company said.
Eli Lilly isn’t the only company to experience changes in business practice due to COVID-19. On Sunday, Belgium-based Galapagos announced it was pausing enrollment in some clinical trials. Chief Executive Officer Onno van de Stolpe said the company is pausing enrollment in its filgotinib trials in order to help protect patient safety. This decision includes the Phase II and Phase III trials of filgotinib in Crohn’s disease, psoriatic arthritis and uveitis. The decision does not affect the Phase III SELECTION program in ulcerative colitis, as this study is fully enrolled. Galapagos anticipates data from that trial in the second quarter of this year. The company also believes the Phase III program in ankylosing spondylitis will now start later this year.
“I want to assure you that the Galapagos team continues to face this unprecedented situation with resilience. And as challenging as the COVID-19 crisis is, this too shall pass. Supported by a strong balance sheet, I firmly believe that we can weather this storm. This also comes with a responsibility that we do not take lightly: we are more determined than ever in our unwavering ambition to bring innovation to patients worldwide,” van de Stolpe said in a statement.
Last week, New Jersey-based Provention Bio announced a temporary pause in its Phase III diabetes trial due to concerns over the virus. The company said the pause is being taken out of an abundance of caution to protect patients, caregivers, clinical site staff, company employees and contractors at this critical juncture in the collective global efforts to combat the COVID-19 pandemic.
