The disruption of clinical trials due to the novel coronavirus pandemic is becoming an almost daily ritual.
The scope of the clinical trial delays and suspension — like just about everything touched by this expanding crisis — is hard to quantify, but consider this snapshot: Biotech and pharma companies are currently running more than 120 Phase 3 clinical trials with top-line data readouts expected before the end of the year, according to search of a database maintained by BioMedTracker.
The downstream impact for patients and the drug industry could be substantial, even if regulatory agencies like the Food and Drug Administration provide assistance. Without data from pivotal clinical trials, new drug filings will be delayed, meaning some important new medicines will take longer to reach the market.
On Sunday evening, Onno van de Stolpe, the CEO of Belgian drug maker Galapagos, used Twitter to announce a decision to pause patient enrollment into seven mid- and late-stage studies of filgotinib, a drug being developed with partner Gilead Sciences to treat diseases of the immune system.
The decision was made to “help protect patient safety,” tweeted van de Stolpe. “I firmly believe that we will weather this storm and come out stronger. We are more determined than ever in our unwavering ambition to bring innovation to patients. Stay safe.”
On Monday morning, Eli Lilly said it will delay the start of new clinical trials and suspend enrollment in “most” ongoing studies. Trials in which patient enrollment has already been completed will continue.
Lilly is listed as the sponsor of 86 clinical trials currently enrolling patients, including 30 in Phase 3, according to ClinicalTrials.gov. Another 78 studies are active but no longer recruiting patients.
BIO, the industry trade group, is still collecting information from member companies, but two significant challenges to conducting clinical trials in the current environment have emerged: Missing or delayed data collection from ongoing clinical trials, particularly at hospital sites overwhelmed by Covid-19 cases; and difficulties getting new clinical trials up and running because patients are reluctant to enroll or unable to visit hospitals, said Cartier Esham, BIO’s senior vice president of science and regulatory affairs.
It’s impossible to know how many clinical trials will be affected adversely by the coronavirus outbreak, but STAT’s search of the BioMedTracker database found 120 Phase 3 clinical trials being conducted by biotech and pharma companies with market values greater than $300 million. All of these clinical trials were expected to announce top-line results before the end of the year.
The search includes some closely followed drugs with blockbuster projections: The asthma medicine tezepelumab from Amgen and AstraZeneca; Agios Pharma’s rare disease treatment mitapivat; Bristol-Myers Squibb’s ozanimod; the heart failure drug omecamtiv mecarbil from Amgen and Cytokinetics; and fitusiran, a hemophilia therapy from Sanofi and Alnylam Pharma, among others.
STAT also queried the same database to look at mid-stage, or Phase 2, clinical trials, some of which could also serve as the basis for FDA submissions. The search found 160 such studies with data readouts planned for this year.
Sunday’s night’s suspension of filgotinib studies affects ongoing Phase 3 studies in Crohn’s disease and psoriatic arthritis, plus an additional five mid-stage studies. A Phase 3 study in Crohn’s disease has already completed enrollment and should therefore still read out results during the second quarter, Galapagos said.
Filgotinib is already under review in the U.S. and Europe as a potential new treatment for rheumatoid arthritis.
Bristol-Myers Squibb is expecting an FDA approval decision on ozanimod in multiple sclerosis on Wednesday, but a Phase 3 study in ulcerative colitis is still enrolling patients. Bristol has eight Phase 3 studies underway with results expected this year, including two studies of its closely followed psoriasis drug BMS-986165.
AstraZeneca is conducting 12 Phase 3 studies currently, including studies involving its checkpoint inhibitor Imfinzi that have all completed enrollment. Several studies of the asthma treatment candidate tezepelumab, partnered with Amgen, are expected to read out in the second half of the year.
With hospitals diverting resources to care for Covid-19 patients, gene and cell therapies that require extended hospital visits to prepare or receive treatment will almost certainly be interrupted in some way. This could slow the development of CRISPR-based treatments for rare diseases from CRISPR Therapeutics, Vertex Pharma and Editas Medicine, among others. Likewise, the impact might be felt by developers of gene therapies like Roche, Pfizer and Sarepta Therapeutics.