As COVID-19 continues to expand across the globe, more pharmaceutical companies are hitting the brakes on clinical trials as part of an effort to ease the burden on doctors and facilities needed to treat patients combating the disease.
As COVID-19 continues to expand across the globe, more pharmaceutical companies are hitting the brakes on clinical trials as part of an effort to ease the burden on doctors and facilities needed to treat patients combating the disease.
This week, Pfizer, Merck, Enanta and Bristol Myers Squibb join the likes of Eli Lilly, Provention Bio and Belgium-based Galapagos in pausing the launch of some new studies, as well as enrollment in some ongoing studies. On Wednesday, Pfizer said it would institute a three-week recruitment delay for ongoing global trials due to the outbreak. According to Reuters, Pfizer’s decision to pause enrollment would not include those studies that are recruiting patients for life-threatening conditions or that have no other therapeutic options. The pause is not expected to hinder ongoing trials that have already been fully recruited.
“The impact on our operations is highly uncertain and cannot be predicted with confidence. Factors that will influence the impact include the economic consequences and duration of the outbreak, new information that emerges concerning the severity of the coronavirus and actions taken to contain the outbreak or treat its impact, among others. The extent of the adverse impact on our operations, including, among others, our manufacturing and supply chain, sales and marketing and clinical trial operations, will depend on the extent and severity of the continued spread of the coronavirus globally, and, ultimately, the outbreak could have a material adverse impact on our business and our financial results,” Pfizer said in a filing with the U.S. Securities and Exchange Commission.
Merck is also suspending enrollment in some trials due to the pandemic. The pharma giant told Endpoints that the pause will not impact some trials in China, where the novel coronavirus began. The company said it will use an “operational continuity plan” to keep those trials going.
On Thursday, Watertown, Mass.-based Enanta Pharmaceuticals announced it was making adjustments to some of its ongoing clinical studies. Chief Executive Officer Jay Luly said it paused its Phase IIb ARGON-2 study in NASH and is also pausing its Phase 1a/1b study of EDP-514 in nuc-suppressed hepatitis B (HBV) patients, which was initiated earlier this quarter.
“The COVID-19 pandemic represents a significant, ongoing public health threat and has created an unprecedented burden on healthcare systems across the globe. With the safety of our clinical trial participants in mind, coupled with a desire to alleviate many of the resource constraints at clinical trial sites, Enanta has proactively decided to make adjustments to some of our clinical programs,” Luly said in a statement.
Enanta said it will initiate its two Phase II respiratory syncytial virus (RSV) studies of EDP-938 in pediatric and transplant patients later this year.
In a note to investors, BMS said it will not initiate nor activate new study sites until at least April 13. The company noted that the timeline could be extended due to the spread of the virus. Existing clinical sites can continue to recruit new patients when it is appropriate, the company said. BMS said it has also temporarily suspended the screening, enrollment and apheresis in its cellular therapy clinical trials. The decision is not considered an urgent safety measure and does not impact the ongoing Biologics License Application (BLA) activities with the U.S. FDA for idecabtagene vicleucel or lisocabtagene maraleucel, the company stressed in its note. The clinical trials that form the basis for these applications have completed enrollment.
Other companies continue to monitor the situation regarding the impact of COVID-19 on its clinical trials. AbbVie said it is monitoring its clinical trials and is taking precautions to protect the safety of study participants, clinical trial site staff and employees. The company said it will continue to evaluate any local support our study participants may require to maintain their safe involvement in our clinical trials. Amgen likewise is monitoring its ongoing clinical sites.
“We have a vast amount of clinical work going on at investigational sites across the globe. We are monitoring this dynamic situation closely,” Amgen said in a statement.
