Chimerix, Inc. Abandons Testing of Experimental Ebola Drug in Liberia
Published: Feb 03, 2015
February 2, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff
Chimerix, Inc. announced on Friday that it would no longer participate in clinical studies of brincidofovir for the treatment of Ebola, including a study in Liberia conducted by researchers at the University of Oxford . Chimerix indicated the decision came after a discussion with the U.S. Food and Drug Administration (FDA) and cited the decline of new cases of Ebola in Liberia as a cause.
The number of new Ebola cases has “decreased significantly” and at present “only a handful of patients” have enrolled in the single-arm study of brincidofovir led by the University of Oxford and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) in conjunction with Médecins Sans Frontières (MSF), according to the company.
“We were honored to be able to work with the researchers at University of Oxford and ISARIC together with MSF to initiate the first clinical trial of an investigational agent during an outbreak,” said M. Michelle Berrey, president and chief executive officer of Chimerix, in a statement. “The progress in controlling the Ebola outbreak in Liberia is to be commended,” Berrey concluded.
Experts have expressed concern in the past several weeks that the falling number of Ebola cases could hamper efforts to develop effective treatments and vaccines for the disease, BioSpace reported last week.
“Because case numbers are starting to come down it will become harder and harder to show if the vaccine is having any impact,” Jonathan Ball, a virus expert based at Nottingham University, told the BBC last week when GlaxoSmithKline announced that its vaccine had been shipped to Liberia. “Ultimately we may be in position in a few months’ time where we don’t know whether this vaccine is effective in humans.”
His words have proven prophetic with respect to a drug treatment for Ebola, but not necessarily for the vaccines currently in development. Brincidofovir as a treatment for Ebola surprised many researchers because the drug had been developed to target infections with DNA-containing viruses, whereas Ebola is an RNA virus.
In fact, the U.S. has been stockpiling the drug, not yet approved by the U.S. FDA, in case of a smallpox virus outbreak, according to Vincent Racaniello, professor of Microbiology & Immunology in the College of Physicians and Surgeons of Columbia University.
In early 2014 when the Ebola outbreak hit, Chimerix provided the National Institutes of Health (NIH) and the Center for Disease Control (CDC) with brincidofovir for testing. Researchers found that the drug inhibited Ebola virus replication in cell culture. This result in combination with the drug’s safety profile for human use caused the FDA to authorize the drug to treat the first U.S. Ebola patient, Thomas Eric Duncan. The man later passed away due to the infection.
Despite the discontinuation of participation in the Ebola clinical trials, Chimerix will continue to develop brincidofovir for the treatment of other diseases. Chimerix will continue to push forward with our development of brincidofovir for the prevention and treatment of serious viral infections in transplant recipients and other immunocompromised patients,” Berrey concluded in the company’s statement.