The CMV efficacy trial, also known as the SUPPRESS trial, has enrolled 450 patients. CMV is often a concern for those who have gone through a bone marrow transplant or a hematopoietic cell transplant (HCT). This study aims to evaluate the antiviral candidate's efficacy against CMV and other pathogens that can coexist in cases involving patients with compromised immune systems. These include Epstein-Barr Virus, the adenovirus and the BK virus.
"As we look ahead to the results of the SUPPRESS trial, we are working closely with the [U.S. Food and Drug Administration] as we prepare the regulatory submission of brincidofovir for CMV," Dr. M. Michelle Berrey, president and CEO of Chimerix, said. "Brincidofovir has the potential to be the first product indicated for the prevention of CMV in HCT recipients, which would be paradigm-changing in managing HCT patients after transplant. We also remain committed to continuing our groundbreaking work studying brincidofovir for the treatment of adenovirus, and we look forward to determining an appropriate regulatory pathway to potentially bring a much-needed treatment option to a fragile patient population."
The adenovirus-specific trial has enrolled approximately 200 patients. A later phase of this trial will evaluate the efficacy of the candidate against CMV and other complications in cases involving kidney transplants. CMV takes the form of an infection of the lungs or other organ systems, and has risks of increasing the chances of infection from other viruses, fungi and bacteria.