Ongoing clinical trials aimed at defeating the coronavirus pandemic with Gilead Sciences Inc.'s experimental antiviral drug remdesivir are set to show results soon, but lack of access to the potential treatment has hindered progress for some institutions close to the pandemic.
Northwell Health Inc., the largest healthcare provider in New York City and the state, has an agreement with Gilead to begin enrolling patients for two clinical trials of remdesivir in moderate and severe patients. New York has the most cases of COVID-19 in the U.S.
Northwell Health's Feinstein Institutes CEO Kevin Tracey
Source: Northwell Health
Kevin Tracey, CEO of Northwell's research arm the Feinstein Institutes, told S&P Global Market Intelligence that the clinics have not had access to the drug and no patients have been treated yet.
"We have many dozens of patients eligible for that trial but we're waiting to receive the drug," Tracey said.
Gilead has suspended emergency access to its drug outside of clinical trials due to overwhelming demand.
The Foster City, Calif.-based company received orphan-drug status for remdesivir from the U.S. Food and Drug Administration on March 26, which would have given the company exclusive rights to sell the drug for seven years. Gilead rescinded the designation the same day amid criticism from more than 50 activist groups and U.S. Senator and Democratic presidential candidate Bernie Sanders, I-Vt., about monopolizing on the pandemic.
The Feinstein Institutes have also partnered with Regeneron Pharmaceuticals Inc. and Sanofi to run a clinical trial treating patients with another prospective drug called Kevzara, an immunological medicine approved for use in rheumatoid arthritis. The drug has the potential to treat patients with severe pneumonia-like symptoms.
Tracey said Feinstein is one of the leading enrollers in the nationwide Kevzara trial, with almost 50 patients taking part in the study.
"They're sending us plenty of drug and we have many, many dozens more patients that would potentially be eligible to be enrolled," Tracey said. He said results from the trial could be available soon — within "days to weeks, not weeks to months."
Tracey said the Feinstein Institutes could potentially enroll many hundreds of patients in the Regeneron and Gilead trials based on their design and the number of patients in the studies. "That's going to be based on the availability of the drug and how this plays out in New York City."
The cost to medical research
While rigorous medical research will no doubt contribute to the stemming of the COVID-19 pandemic, Tracey and other industry experts said other areas of medicine have suffered as a result of the virus.
Of the 2,000 to 2,500 patients enrolled in clinical trials each year at Northwell and the Feinstein Institutes, Tracey estimated that two-thirds of them are at some stage of stopping enrollment or on hold.
"The vast majority of the ones on hold are not for critically ill people," Tracey said. "We still have open studies that are non-COVID for critically ill patients and patients with serious underlying diseases."
Companies like Eli Lilly and Co. have put a stop to new clinical trials altogether, halting enrollment during the pandemic. Other big pharma companies like New York's Pfizer Inc. have cut back screening for early-stage studies as well.
Tracey said the long-term effect of the research slowdown would be similar to that of other industries, where an economic downturn has ground many operations to a halt.
Cowen analyst Steve Scala said in a March 25 note that about 20% of trials are actively recruiting in areas outside of oncology or other life-threatening diseases, and these are most vulnerable to delay. The trial pauses could put some biopharma earnings at risk through 2025.
SVB Leerink analyst Daina Graybosch said in a March 26 note that the COVID-19 pandemic would likely pause or disrupt clinical trial progress in oncology as well, where healthcare interaction is most important, but that most companies would endure.
"Some impact to trials is almost certain, given global re-direction of healthcare resources and efforts to reduce cancer patient exposure to the virus," Graybosch said.