Chimerix's lead product candidate, brincidofovir (CMX001), is an oral nucleotide analog that has shown broad-spectrum antiviral activity against all five families of double-stranded DNA (dsDNA) viruses that affect humans, including cytomegalovirus (CMV), adenovirus (AdV), BK virus (BKV) and herpes simplex viruses. Brincidofovir has a favorable safety and tolerability profile, with no evidence of kidney or bone marrow toxicity in nearly 900 patients dosed with brincidofovir to date. Chimerix believes that brincidofovir has the potential to be the first broad-spectrum antiviral for the prevention and treatment of clinically significant infections and diseases caused by dsDNA viruses.
Following positive Phase 2 results, in the third quarter of 2013 Chimerix initiated the Phase 3 SUPPRESS trial which will support Chimerix's initial regulatory submission for prevention of CMV infection in adult hematopoietic cell transplant (HCT) recipients. Chimerix recently presented results from its Phase 2 trial in AdV, an often-fatal infection with no approved treatment. A brincidofovir dose of 100 mg twice weekly demonstrated a potent antiviral effect on levels of AdV in the blood, and a numeric decrease in overall mortality. Chimerix continues to work with the Biomedical Advanced Research and Development Authority (BARDA) to develop brincidofovir as a medical countermeasure against smallpox.
About Cytomegalovirus (CMV) and Double-Stranded DNA (dsDNA) Viruses
CMV is a member of the herpesvirus family and is the most common infectious pathogen in transplant recipients. A majority of adults in the US have been exposed to CMV, generally in childhood, with lifelong viral latency established following resolution. In healthy individuals with a functioning immune system, CMV remains dormant throughout life. A functioning immune system protects an infected individual against future exposure to CMV but does not clear the virus from their body. In immunocompromised individuals with weakened immune systems, such as transplant recipients, CMV often reactivates during the post-transplant period when the immune system is rebuilding itself. No therapies are approved for the prevention of CMV in HCT recipients. Currently available systemic anti-CMV agents can be effective against CMV; however, their use is limited by significant toxicities, including bone marrow suppression and renal impairment, and these therapies are only approved for certain solid organ transplant patient populations. CMV infection is known to correlate with progression to CMV disease and death. CMV itself is immunosuppressive and reactivation of the virus can predispose a patient to other opportunistic viral infections in addition to fungal and bacterial infections.
Chimerix Announces Publication of Positive Phase 2 Results of Brincidofovir (CMX001) in the New England Journal of Medicine
Phase 2 Trial Evaluated Brincidofovir for the Prevention of Cytomegalovirus (CMV) Infection in Hematopoietic Cell Transplant Recipients
DURHAM, N.C., Sept. 26, 2013 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced the publication of results from its Phase 2 Study CMX001-201 evaluating brincidofovir (CMX001) for the prevention of cytomegalovirus (CMV) infection in hematopoietic cell transplant (HCT) recipients. The article, entitled "CMX001 to Prevent Cytomegalovirus Disease in Hematopoietic-Cell Transplantation," appears in the September 26th issue of the New England Journal of Medicine (N Engl J Med 369:1227-36).
Brincidofovir, Chimerix's lead product candidate, is an investigational oral nucleotide analog lipid-conjugate that has shown broad-spectrum antiviral activity against double-stranded DNA (dsDNA) viruses including CMV. Study CMX001-201, a 230-subject, randomized, placebo-controlled, double-blind, dose-escalation study, met the primary endpoint of reduction in CMV viremia and/or CMV disease for brincidofovir 100 mg twice weekly versus placebo (p=0.002). Based on these positive Phase 2 results, Chimerix recently initiated the Phase 3 SUPPRESS trial of brincidofovir 100 mg twice weekly for the prevention of CMV infection in HCT recipients.
"Although prevention of CMV infection has been recognized as a superior approach to decrease CMV-related morbidity and mortality in the months following hematopoietic cell transplantation, the side effects of available antivirals have precluded their approval and use in this setting," said M. Michelle Berrey, MD, MPH, Chief Medical Officer of Chimerix. "The significant decrease in CMV events and lack of hematologic and renal toxicity shown in Study CMX001-201 provided the supportive data to allow us to progress brincidofovir into the Phase 3 SUPPRESS trial."