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 and RESEARCH TRIANGLE PARK, N.C., Sept. 15 /PRNewswire/ -- 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.  

About CMX001

CMX001 combines Chimerix's PIM (Phospholipid Intramembrane Microfluidization) Conjugate Technology with cidofovir, an approved antiviral agent requiring intravenous administration, with the aim of creating a well-tolerated oral antiviral agent with potent broad-spectrum activity. CMX001 is initially being developed for both commercial and medical preparedness uses.  A Phase 2 clinical trial is underway to assess the safety, tolerability and ability of CMX001 to prevent or control cytomegalovirus (CMV) infection in stem cell transplant recipients.  In addition, Chimerix is conducting a multi-dose Phase 1 clinical trial of CMX001 in transplant recipients with BK viruria, which like CMV can cause serious complications in immunocompromised patients.  In clinical testing to date, CMX001 has shown oral bioavailability in humans and has demonstrated a positive safety profile.    

About Chimerix

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 1 and Phase 2 clinical studies in immunocompromised transplant and cancer patients for the treatment of life-threatening viruses, such as BK virus, cytomegalovirus and adenovirus.  CMX001 is also being developed as a biodefense countermeasure in the event of a smallpox release.  Chimerix has advanced a second antiviral compound, CMX157, into Phase 1 clinical studies 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.  

Privately-held, Chimerix has received financing from Sanderling Ventures, Canaan Partners, Alta Partners, Asset Management Company and Frazier Healthcare Ventures, as well as significant funding from the National Institute of Allergy and Infectious Diseases.  For additional information on Chimerix, please visit http://www.chimerix.com.

SOURCE Chimerix, Inc.

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