Coronavirus Upends Testing of New Drugs

By Jared S. Hopkins

The world-wide spread of the new coronavirus is throwing into disarray studies critical to the development of promising new medicines.

The pandemic is causing delays in starting clinical drug trials and temporarily halting others, according to companies, consultants and industry officials. Patients enrolled in some studies have stopped showing up at trial sites, while hospitals supposed to see trial subjects are shifting attention to tackling coronavirus patients. Industry scientists, meanwhile, can't travel for research.

"Things are just getting canceled left and right," said Christian Burns, president of ClinEdge LLC, which helps drug companies recruit drug-trial participants in more than 30 countries.

The disruptions, which aren't affecting research into coronavirus drugs and vaccines, mean it could take longer for new drugs aimed at treating conditions like diabetes and liver disease to reach patients, if the medicines eventually prove to work safely.

Company revenue could suffer, too, if future sales of drugs are deferred because of trial delays.

The drug studies most affected are in heavy-hit regions, such as Italy, China and South Korea, where lockdowns have restricted the ability of patients to leave their homes, enroll in trials and travel to study sites to get experimental treatments, industry officials say. Studies in the U.S. are also starting to feel an impact.

Bristol-Myers Squibb Co. and Eli Lilly & Co. said this week they will hold off starting most new trials, citing safety concerns. Bristol is also temporarily halting infusions of experimental cellular therapies under study, while Lilly said it will pause enrolling new study subjects for trials already under way. Pfizer Inc. said Wednesday it is suspending recruitment of patients for most new and ongoing studies that don't involve life-threatening conditions.

Trials play a pivotal role in the introduction of new medicines. Regulators rely on the results to gauge whether an experimental drug is safe and works, and should be approved for use. Companies can spend tens of millions of dollars to carry out a single study.

Many current drug trials for critical ailments are expected to continue, though, because hospitals and drugmakers view them as crucial for patients. Also, patients testing drugs for fatal or critical conditions such as cancer are motivated not to skip treatments.

The pandemic, though, threatens to delay research into much-needed treatments for other critical conditions.

Nearly two-thirds of 170 clinical trial sites surveyed in the U.S. believe patients will be much less or somewhat less likely to enroll in new clinical research trials due to the coronavirus, according to a review last week from consultancy Continuum Clinical. And nearly half the sites expect patients enrolled in trials to be much less or somewhat less willing to keep participating.

"That's where this could be really damaging," said Continuum President Neil Weisman. "If too many patients discontinue with a clinical trial, pharma companies aren't going to have enough data to prove their products hit an endpoint and show their drug does what they hope it would do."

The Northwell Health system on Long Island, N.Y., has paused about 50 clinical trials to protect patients and free up more than 40 staffers for coronavirus drug research. "Right now, I'm prioritizing," said Kevin Tracey, president of Northwell's Feinstein Institutes for Medical Research.

Arrowhead Pharmaceuticals Inc., which is based in Pasadena, Calif., last week suspended enrollment in a liver-disease trial for at least four weeks because the study needs patients who are at risk for coronavirus infections and who must get a liver biopsy, which requires visiting a clinic, said Chief Executive Christopher Anzalone.

"There's probably some type of disaster-planning going on in every single company," said Laurie Halloran, chief executive of Halloran Consulting Group, which advises firms on clinical trials.

To keep trials moving forward despite the virus, some drugmakers are trying to transfer to patients' homes the work typically done at research sites.

Scynexis Inc., of Jersey City, N.J., is directing patients in a trial for its experimental fungal treatment to have blood drawn at home or alternative sites, and to receive the drug at home, after some patients missed appointments in Italy and other European countries, said Chief Executive Marco Taglietti.

When Chinese drugmaker BeiGene Ltd., which focuses on cancer treatments, saw that patients weren't visiting test sites and hospitals in China were turning their attention to coronavirus, the drugmaker increased remote-monitoring of patients, said Eric Hedrick, BeiGene's chief adviser.

The U.S. Food and Drug Administration provided guidance last week aimed at allowing trials to continue while ensuring patient safety. The agency recommended screening enrolled patients for the new coronavirus, while suggesting alternative ways for patients to access treatments

It also said it will allow trial procedures that typically need approvals by the FDA or trial safety boards to proceed as long as they are reported afterward.

Write to Jared S. Hopkins at jared.hopkins@wsj.com

(END) Dow Jones Newswires

March 27, 2020 05:44 ET (09:44 GMT)

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