Galapagos halt trials due to impact coronavirus

01 April 2020


trials

Eli Lilly became the first large pharmaceutical company to announce delays to its clinical trials as a result of the outbreak of the novel coronavirus. Biotechs Galapagos and ObsEva also postponed studies as the fast-spreading pandemic continued to take its toll on clinical research.

Lilly will delay “most” new study starts and pause enrolling healthy volunteers or new patients in “most” ongoing clinical trials. Some patients enrolled in current studies will continue to get their experimental medicines, but Lilly will make those calls on a study-by-study basis.

The decision comes as more and more companies across the globe have begun to halt human testing of experimental medicines, a move made to help slow the spread of the virus and decrease the burden on healthcare workers.

Dive Insight:
Prior to Monday’s announcement from Lilly, the only clinical trial delays that had been publicly disclosed were one-off changes to trials from a handful of smaller drugmakers.

The list of biotechs affected — which already included Provention Bio, Iveric Bio and others — continues to grow. Belgian biotech Galapagos on Sunday paused multiple studies of its closely watched experimental drug filgotinib, which is in late-stage studies for several autoimmune diseases. ObsEva, meanwhile, won’t screen new patients for two studies of its drug linzagolix for pain associated with endometriosis.

But Lilly’s move is a sign of far wider-reaching effects on clinical research. The company runs hundreds of clinical studies in heart disease, cancer, autoimmune diseases and more at medical centers across the globe.

In a statement, the pharma noted that many of those institutions have had to focus on caring for patients with COVID-19, the disease caused by the new coronavirus, and “limit or cease other activities.”

Already spread thin by the burden of the pandemic — there were now more than 350,000 confirmed cases globally, and over 35,000 in the U.S. as of Monday, according to the Johns Hopkins University database — it’s hard for these facilities to put resources into new trials or enrolling new patients. Lilly is trying to alleviate some of the pressure by repurposing labs to conduct COVID-19 diagnostic testing and research possible therapies. But that means it will have to curtail non-COVID-19 research, said chief medical officer Tim Garnett, in a statement.

“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 combating COVID-19,” he said in the statement.

Lilly will evaluate ongoing trials “with study-by-study consideration,” as stopping some of them might disrupt treatment and “potentially diminish the societal value” of the research those studies are gathering, Garnett said.

Some 86 studies sponsored by Lilly are listed as “recruiting” on the federal database clinicaltrials.gov, although that count may not include all studies it recently started.

Some notable ones underway or set to start include a 12,500-patient cardiovascular outcomes study for heart drug tirzepatide (listed on clinicaltrials.gov as “not yet recruiting”), and late-stage studies of targeted cancer medicine selpercatinib. A Lilly spokesperson wouldn’t specify exactly how many of its trials are being affected, but confirmed to BioPharma Dive after this article was published that the company doesn’t expect the projected timelines for tirzepatide and selpercatinib to change.

Analysts expect more such announcements to come. RBC Capital Markets analyst Brian Abrahams wrote recently that “virtually all non-coronavirus clinical studies” other than those for “immediately life-threatening conditions or severe unmet needs” will likely need to be temporarily stopped.


Published by biopharmadive.com on March 23, 2020 
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