Chimerix has announced plans to end its participation in all current and future clinical efficacy trials of antiviral Ebola drug, brincidofovir, due to the drop in number of new cases of confirmed EVD in Liberia in recent weeks.
The decision includes the Liberia trial and the supportive Phase II trial of brincidofovir for Ebola Virus Disease (EVD), Study 205.
In January, the company started an open-label, Phase II trial to evaluate brincidofovir’s efficacy in 140 Liberian patients with EVD at Médecins Sans Frontières (MSF)’s ELWA 3 Ebola Management Centre in Monrovia, Liberia.
The Liberia trial is led by the University of Oxford and International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) with operational support from MSF and funding from The Wellcome Trust.
According to the company, this decision will not impact its continued focus on advancing brincidofovir in pivotal trials of cytomegalovirus (CMV) prevention in recipients of allogeneic hematopoietic transplant as well as to treat adenovirus infection in immunocompromised patients.
The decision to halt the trial in Liberia was made after discussions with the US Food and Drug Administration (FDA) and investigators at the Oxford University.
Chimerix president and CEO Michelle Berrey said: "We were honoured 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.
"The progress in controlling the Ebola outbreak in Liberia is to be commended.
"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."
According to the World Health Organization (WHO), over 22,000 people had been infected with Ebola and more than 8,800 had died, mainly in the three West African countries.
Image: Electron micrograph of an Ebola virus virion. Photo: courtesy of CDC/Cynthia Goldsmith.
