Chimerix reported today that it has received approval from the U.S. Food and Drug Administration to launch a Phase 2 clinical trial of Brincidofovir for the treatment of Ebola virus.
Earlier this month, Chimerix was granted Emergency Investigational New Drug (EIND) status for Brincidofovir (CMX001) for use in patients with Ebola virus. The drug has already been administered to two Ebola patients, including Thomas Eric Duncan.
The new trial will test safety, tolerability and efficacy for Brincidofovir.
“We want to do our part first to determine if there is a role for Brincidofovir, we do have emergency INDs that are currently in place and we do have a protocol that is under review at the FDA to be finalized under a new IND by the end of this week,” said Chimerix CEO Michelle Berrey in a corporate update to analysts.
“We are working to identify the key hospitals, the key medical centers where we believe that protocol should be implemented where we know they have adequate training; they have adequate facilities to be caring for individual who are confirmed to be infected with Ebola virus and to our appropriate candidates for Brincidofovir,” stated Berrey.
Wide-Ranging Utility of Brincidofovir
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 adenoviruses. The drug has not been associated with kidney or bone marrow toxicity in over 1,000 patients treated to date, side effects that can be treatment limiting with currently available antivirals.
Building on the positive Phase 2 results in cytomegalovirus (CMV) prevention, Chimerix initiated the Phase 3 SUPPRESS trial in 2013. If positive, data from SUPPRESS will support Chimerix’s initial regulatory submission for brincidofovir for the prevention of CMV infection in adult hematopoietic cell transplant (HCT) recipients.
Chimerix recently initiated AdVise, a Phase 3 trial in adenovirus, which is an often-fatal viral infection with no approved treatment; enrollment is ongoing for the pilot portion of the trial.
BARDA Backing for Investigation as Smallpox Countermeasure
Chimerix is also working with the Biomedical Advanced Research and Development Authority (BARDA) to develop brincidofovir as a medical countermeasure against smallpox. Brincidofovir has received Fast Track designation from the FDA for CMV, adenovirus, and smallpox.
The FDA has authorized a Phase 2 protocol for investigating Brincidofovir to begin immediately. Chimerix stated that Brincidofovir tablets are available for immediate use in clinical trials.