Chimerix Antiviral CMX001 Demonstrates Positive Safety and Pharmacokinetics in 46 patients with compromised renal function
CMX001 Achieves Systemic Exposure and Shows No Evidence of Nephrotoxicity in 46 Patients Treated Under Investigator-held Emergency INDs
Data Presented at 50th ICAAC Late-Breaker Session
Boston, MA and Research Triangle Park, NC, September 15, 2010 - Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, today presented promising clinical data for CMX001 in a late-breaker poster session at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
Wendy Painter, M.D., Chief Medical Officer of Chimerix, presented pharmacokinetic and preliminary safety data pertaining to renal function from 46 patients enrolled in Investigator-held Emergency Investigational New Drug applications (EINDs). The majority of patients participating in the EIND program had received stem cell or bone marrow transplant procedures, and presented with severe renal impairment attributed to prior administration of the antiviral drug Vistide® (cidofovir). Data from the EIND patient case studies demonstrate that following the administration of CMX001, renal function improved or remained unchanged in the majority of patients. Further, moderate-to-severe renal impairment in both pediatric and adult patients, did not alter systemic exposure to CMX001. CMX001 exposure was also not affected by hemodialysis.
“CMX001 was well tolerated in patients with severe viral infections with no evidence of nephrotoxicity, which has been a significant dose-limiting factor for several existing therapies,” stated Dr. Painter. “The data also show that the pharmacokinetics of CMX001 are unchanged in patients with renal impairment, a major complication for severely ill patients. We are gratified by the growing body of evidence supporting CMX001’s broad-spectrum antiviral activity and excellent tolerability profile.”
To date, Chimerix has treated nearly 100 patients under investigator-held EINDs or foreign equivalent at leading medical centers in the US, Canada and Europe for the treatment of a wide-range of life-threatening infections caused by double-stranded DNA viruses for which there are either no FDA-approved treatments or where patients have failed the available treatment.
These data were presented at the 50th ICAAC during the late-breaker “Pharmacokinetics and Pharmacodynamics of HIV and Antiviral Agents” session at 9:30 am ET in a presentation titled “Compromised Renal Function Does Not Affect the Pharmacokinetics of CMX001 in Patients with Severe Double-Stranded DNA Virus Infections” (Abstract #A1-2017a). Hosted by the American Society for Microbiology (ASM), the 50th ICAAC provides physicians, researchers, and other medical professionals from around the world an opportunity to deliberate on global solutions for infectious disease. FULL PRESS RELEASE ATTACHED
Posted: September 2010