Lilly, Galapagos Put Some Trials On Hold Due To Coronavirus Concerns
Executive Summary
Biopharma companies struggle with which trials, if any, to pause or delay. Lilly said it wants to ease the burden on health care facilities, while Galapagos said its choice is related to patient safety.
Eli Lilly & Co. and Galapagos NV are among the latest companies to disclose that they have paused enrollment in or are delaying the start of clinical trials for drug candidates due to COVID-19-related concerns. However, they will not be the last, since biopharmaceutical firms globally are struggling with whether to halt ongoing studies or wait to initiate new trials.
Assessments will be made on a case-by-case basis depending on many factors, including whether clinical trial participation could be the difference between life or death for some patients, whether patients’ immune systems could handle a COVID-19 infection, and the capacity of trial sites to carry out studies while also treating COVID-19 patients.
Lilly said that it did not want its trials to use health care resources needed to fight the novel coronavirus, while Galapagos said it wanted to protect patients that might be enrolled in its filgotinib trials. Neither company said it had patients or clinical trial sites dropping out of its studies.
“These are proactive steps that Lilly is taking to ease the burden on participating health care facilities and allow physicians to focus more of their efforts on combatting COVID-19. They were not done in response to clinical site closures or a lack of patient enrollment,” a company spokesperson told Scrip.
Lilly did not list which trials are impacted, but the company said on 23 March it will delay most new study starts and pause enrollment in most ongoing studies – however, studies with patients already enrolled will continue. Lilly does not want to disrupt patients’ treatments nor diminish the societal value of the data being collected, so the company is maintaining ongoing trials on a study-by-study basis, chief medical officer Tim Garnett said in Lilly’s public statement.
One key clinical trial that the company had expected to start this year was a Phase III head-to-head cardiovascular outcomes study versus Lilly’s Trulicity (dulaglutide) for the dual GIP and GLP-1 receptor agonist tirzepatide in type 2 diabetes. (Also see "Questions Persist On Lilly’s Tirzepatide And Tolerability" - Scrip, 10 Jun, 2019.)
Earlier this year, the company initiated Phase III trials for selpercatinib in first-line non-small cell lung cancer and first-line medullary thyroid cancer; it has filed for US Food and Drug Administration approval of the RET inhibitor in both cancers. (Also see "Lilly Calls It Quits On Pegilodecakin As Loxo Team Reorganizes Cancer R&D" - Scrip, 30 Jan, 2020.)
It is unclear whether the tirzepatide and selpercatinib programs are impacted by Lilly’s decision to pause most of its clinical trial programs to free up health care resources for the treatment of COVID-19 patients.
However, Lilly is contributing to the effort to fight COVID-19 by repurposing some of its laboratories to conduct diagnostic testing for patients and research potential treatments, Garnett noted. Lilly and AbCellera Biologics Inc. have also announced plans to collaborate on a coronavirus vaccine. (Also see "Deal Watch: Lilly, AbCellera Partner To Attempt Rapid COVID-19 Antibody Development" - Scrip, 13 Mar, 2020.)
Galapagos, Provention, Syncona And More Also See Trial Impacts
Meanwhile, Galapagos CEO Onno van de Stolpe said in a 22 March letter to stakeholders that it will pause enrollment in clinical trials for the JAK1 inhibitor filgotinib “to help protect patient safety.” These include the Phase III DIVERSITY trial in Crohn’s disease, Phase III PENGUIN study in psoriatic arthritis, a Phase II trial in uveitis and the Phase II safety studies MANTA and MANTA-Ray. Also, initiation of a Phase III program testing filgotinib in ankylosing spondylitis has been pushed to later in 2020.
However, the Phase III SELECTION program in ulcerative colitis is unaffected, because the study is fully enrolled with results expected in the second quarter of this year.
Galapagos’s filgotinib development partner Gilead Sciences Inc. submitted an NDA to the US FDA in December seeking approval for the oral therapy as a treatment for rheumatoid arthritis and a decision is expected in August. (Also see "Gilead Writes Down Kite Buy As Yescarta Sales Flatten Out" - Scrip, 4 Feb, 2020.) Filgotinib is also under review for approval to treat RA in the EU and Japan. (Also see "Gilead Hopes Selectivity Will Ease Safety Labeling For Filgotinib" - Scrip, 25 Oct, 2019.)
Galapagos’s stock fell 1% to close at $146.05 on 23 March and Lilly fell 2.7% to $119.05 per share after the companies made their COVID-19-related clinical trial announcements.
Lilly and Galapagos join Provention Bio Inc., Addex Therapeutics, IVERIC bio Inc. and a growing list of others in announcing that they have halted enrollment of an ongoing trial or delayed the start of a new trial due to COVID-19. (Also see "Provention Announces First Clinical Trial Delay, Others Follow As COVID-19 Concerns Persist" - Scrip, 18 Mar, 2020.)
The UK-based life science investment firm Syncona Ltd. also announced on 23 March that the crisis situation at health care facilities dealing with growing numbers of COVID-19 patients is impacting its portfolios companies’ clinical trials. It said the delays could set back development programs by at least three months. (Also see "Syncona Biotechs Face Up To Trial Delays Over COVID-19" - Scrip, 23 Mar, 2020.)
On 20 March, Oncopeptides AB said it is pausing enrollment in some studies for its peptide-drug conjugate melflufen (melphalan flufenamide) in the treatment of multiple myeloma, but its pivotal Phase II HORIZON study and Phase III OCEAN trial, as well as the second quarter 2020 filing for melflufen with the FDA, are not affected. (Also see "Accelerated Approval Submission On The HORIZON For Oncopeptides’ Melflufen " - Pink Sheet, 23 May, 2019.)
Follicum AB opted on 18 March to suspend enrollment in a Phase II trial of its hair loss treatment FOL-005 being run in Germany – the trial had just started on 9 March. (Also see "Follicum Details Clinical Progress Of Hair Growth Stimulating Product" - Scrip, 29 Mar, 2018.)
The FDA and European Medicines Agency have both issued guidance on how to deal with clinical trials where data collection has been affected by the pandemic. (Also see "Clinical Trial Sponsors Should Consider Changing Data Collection Amid COVID-19, US FDA Says" - Pink Sheet, 18 Mar, 2020.) However, consultant Laurie Halloran of the Halloran Consulting Group has noted that the guidance is lacking in specifics, though the situation is still early and emerging.
Trial Sites Also Struggling
Clinical trial sites are struggling with whether they should continue ongoing clinical trials and start new ones or halt enrollment and delay new studies, but decisions are being made on a case-by-case basis.
For instance, the Fred Hutchison Cancer Research Center in Seattle – a city that has been struggling to get a handle on COVID-19 infections – is working with regulatory agencies to make sure already enrolled patients can stay on investigational therapies with appropriate monitoring. However, the research center said on 18 March that it is suspending new enrollment in studies, unless the investigators see benefits in specific cancer drug trials that outweigh the COVID-19 infection risk for patients visiting clinical trial sites.
Gary Firestein, director of the Altman Clinical and Translational Research Institute at the University of California, San Diego (UCSD) and dean and associate vice chancellor of translational medicine at UC San Diego School of Medicine, told Scrip that “cancer trials continue on essentially as before. The non-cancer studies have seen study visits decrease by 50%-75%, and we are working on ways to do the visits remotely.”
Firestein said some biopharma companies are delaying new trial initiations, but the studies that are more likely to be delayed or stopped at UCSD are longitudinal or epidemiological studies rather than clinical trials in which patients are being treated with novel drugs, especially cancer drug studies where participation may be a matter of life or death for trial participants.
Disease severity, patients’ underlying health, age of trial enrollees and many other factors are considered when determining which trials to continue or initiate due to COVID-19 concerns, he said.