"Chimerix is passionate about the need to develop effective antiviral therapeutics to improve global health and protect against viral threats such as smallpox. Therefore, we are pleased by the opportunity to provide an update to the World Health Organization on the significant progress being made in the development of CMX001 as a potential dual-use agent," commented Wendy Painter, M.D., M.P.H., Chief Medical Officer of Chimerix. "In addition to proven efficacy in numerous animal studies against pox viruses, we are amassing a significant body of clinical data in critically-ill patients regarding CMX001's safety and antiviral activity against double-stranded DNA viruses."
CMX001 is currently in Phase 2 clinical trials for prophylaxis of human cytomegalovirus infection and under development using the FDA's "Animal Rule" for smallpox infection. It has proven effective in reduction of morbidity and mortality in animal models of smallpox, even when treatment is initiated after the onset of lesions.
CMX001 has a number of advantages over other drugs in development for treatment of smallpox, including: broad-spectrum inhibition of double-stranded DNA (dsDNA) viruses that cause human disease; a high barrier to resistance; convenient oral administration as a tablet or liquid; and no evidence to date of renal toxicity. Uniquely among potential smallpox therapeutics, CMX001's safety and efficacy may be evaluated in patients with life-threatening dsDNA virus infections which share many basic traits with variola virus. Further, CMX001 may be effective in the treatment of and protection against smallpox among the estimated 80-90 million Americans whose immune systems are compromised, such as those under treatment for cancer and many chronic diseases or people living with HIV.
About Chimerix and CMX001
Chimerix is developing novel antiviral therapeutics with the potential to transform patient care in multiple settings, including transplant, oncology, acute care and global health.
The company's lead candidate, CMX001, is in Phase 2 clinical studies in immunocompromised transplant and cancer patients for the treatment of life-threatening viruses, including cytomegalovirus and adenovirus. Over 300 people have received CMX001 to date. CMX001 has been well tolerated in all studies, with a growing body of evidence of the compound's antiviral activity in humans. In Chimerix's ongoing placebo-controlled studies, CMX001 has been administered to more than 200 patients and healthy volunteers. In addition, at the request of leading physicians at over 45 medical centers throughout the United States, Canada, Europe and Israel, CMX001 has been administered to more than 120 patients under investigator-held Emergency Investigational New Drug applications (EINDs) for the treatment of a wide range of infections caused by dsDNA viruses for which there are either no approved treatments or where patients have failed the available treatment. To date, CMX001 has been used to treat patients with 12 different dsDNA viral infections across all five families of dsDNA viruses that affect humans. CMX001 is also being developed as a medical countermeasure in the event of a smallpox release. Chimerix has received significant funding from the National Institutes of Allergy and Infectious Disease to develop CMX001 for smallpox.
Chimerix's second clinical-stage antiviral compound, CMX157, has completed Phase 1 clinical studies. CMX157 is in development as a potent nucleoside analogue against multi-drug resistant HIV infections.
Led by a world-class antiviral drug development team, Chimerix is also leveraging the company's extensive chemical library to pursue new treatments for hepatitis C virus, malaria and other global public health needs. For additional information on Chimerix, please visit http://www.chimerix.com.
SOURCE Chimerix, Inc.
