Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, presented promising clinical data for CMX001 in a late-breaker poster session at the 48th annual meeting of the Infectious Diseases Society of America (IDSA). Data from immunocompromised patients infected with adenovirus and treated with oral CMX001demonstrated a significant drop in viral load compared to individual patient baseline, including several complete responses.
"Adenovirus infections among immunocompromised patients can be potentially fatal, with no approved treatments available. We are pleased by the strong antiviral activity of CMX001 observed in these critically ill transplant patients, who had no other viable therapeutic options," says Wendy P. Painter, MD, chief medical officer of Chimerix. "We believe CMX001 has important potential for the prophylaxis and treatment of double-stranded DNA viruses. Based on the promising data seen in case studies from investigator EINDs, we plan to initiate a controlled Phase 2 study in patients with adenovirus infections early next year, in addition to our ongoing controlled studies of CMX001 for the prevention or control of cytomegalovirus infection."
CMX001 is a broad-spectrum antiviral agent with demonstrated activity against multiple double-stranded DNA viruses, initially being developed by Chimerix for the treatment of viral infections in immunocompromised transplant patients. Thirteen patients with a median age of 12 years (age range of 0.92-66 years) received at least four weeks of treatment with CMX001 for adenovirus disease under investigator-held Emergency Investigational New Drug applications (EINDs).The majority of patients had undergone stem cell transplant procedures and 10 had graft-versus-host-disease (GvHD).Patients were diagnosed with adenovirus infection at a median of 68 days post-transplant.All patients initially received treatment with cidofovir for a median treatment of 21 days and were switched to CMX001 due to refractory adenovirus infection or renal toxicity. Patients were treated with oral CMX001 for a median of 68 days. Virologic response was measured at the end of treatment and defined as a greater than 2 log10 reduction in viral load. Of nine patients evaluable at week eight, viral load was lower compared to individual patient baseline with a median difference of 2.98 log10. Importantly, no drug-related serious adverse events were reported.
These data were presented by Diana Florescu, MD, of the infectious disease division at Nebraska Medical Center.