Chimerix

Clinical Trials

CMX001

Chimerix has completed a Phase 1 clinical study of orally-administered CMX001 in 84 healthy volunteers.  The blinded, randomized, parallel-group, placebo-controlled study evaluated the safety and pharmacokinetics of single and multiple doses of CMX001.  CMX001 was well tolerated at all doses.  In addition, CMX001 was well absorbed after oral dosing, with dose-dependent pharmacokinetics.  A second study to evaluate the relative bioavailability of CMX001 solution and tablet dosage forms and food effect is also complete.

Currently, we are conducting a Phase 1 clinical trial of multi-dose CMX001 in transplant recipients with BK viruria.  We are also initiating a Phase 2 clinical trial of CMX001 in immunocompromised patients with CMV.  For more information about participating in either of these studies, please see www.clinicaltrials.gov.

 

CMX157

We are currently conducting a first-in-human study of CMX157, a novel lipid conjugate of the nucleotide tenofovir with in vitro activity against both tenofovir-sensitive and tenofovir-resistant human immunodeficiency virus (HIV). The Phase 1 dose-escalating clinical study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of CMX157.

 

Emergency INDs

We have received interest from the clinical community to utilize CMX001 in the treatment of critically ill patients stricken with viral illnesses resistant to other medicines. Under emergency Investigational New Drug (e-IND) application protocols, we have been able to provide CMX001 to a handful of leading physicians. A case study of a patient treated with CMX001 which was published by the Centers for Disease Control may be downloaded here.