Chimerix, Inc.'s Brincidofovir Antiviral To Be Tested In West African Ebola Trial
November 14, 2014
By Riley McDermid, BioSpace.com Breaking News Editor
Chimerix, Inc. has gotten the green light from global health regulators to test its antiviral brincidofovir as one of two investigational agents to be evaluated in a clinical study in patients with confirmed Ebola virus in West Africa, the company said late Thursday.
More than a dozen companies are currently in clinical trials to develop vaccines or cures to treat the deadly Ebola virus, which has killed more than 5,000 people since the most recent outbreak began last spring.
In October, the U.S. Food and Drug Administration (FDA) authorized a Phase 2 (Study 205) single-arm study to evaluate the safety and antiviral activity of brincidofovir in subjects with confirmed Ebola. Brincidofovir has also received Fast Track designation from the FDA for the treatment of CMV, adenovirus and smallpox, raising hopes it will also work on Ebola.
"During what is perhaps the greatest acute public health crisis of our lifetimes, we want to recognize the profound sense of urgency and myriad scientific, medical, and clinical development issues being addressed together with multiple federal and international partners,” said M. Michelle Berrey, president and chief executive officer of Chimerix, in a statement.
Chimerix will partner with the University of Oxford on a definitive agreement for supplying brincidofovir for the planned clinical trial. The project will be funded by the Wellcome Trust, while the trial itself will be led by the University of Oxford on behalf of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC), with operational support in West Africa provided by Doctors Without Borders. The World Health Organization (WHO) and local health authorities will be the “boots on the ground” for the clinical research.
“We look forward to finalizing the trial arrangements with ISARIC as soon as possible to allow a better understanding of the potential benefit that brincidofovir could have in this Ebola Virus Disease outbreak," said Berrey.
Brincidofovir is an oral nucleotide analog that has shown in vitro antiviral activity against all five families of DNA viruses that affect humans, including viruses in the herpes virus family and adenovirus. Brincidofovir has not been associated with kidney or bone marrow toxicity in over 1,000 patients treated to date, common side effects from antivirals. Chimerix initiated a Phase 3 SUPPRESS trial in 2013, which it hopes will show brincidofovir can prevent CMV infection in adult hematopoietic cell transplant (HCT) recipients. Chimerix and the Biomedical Advanced Research and Development Authority (BARDA) are currently developing brincidofovir as a medical countermeasure against smallpox.