Chimerix, a biotechnology company developing novel antiviral therapeutics, has announced the final data from Phase II study 201 evaluating CMX001 for the prevention of cytomegalovirus (CMV).
CMX001 is a broad spectrum, lipid-antiviral-conjugate that delivers high intracellular levels of the active antiviral agent cidofovir-diphosphate and also has activity against dsDNA viruses.
The randomised placebo-controlled Phase II study of CMX001 included 230 subjects, who were randomised (3:1) to receive CMX001 or placebo in five sequential, dose-escalating cohorts. In the study, subjects were dosed either once weekly (QW) or twice weekly (BIW) for nine to 11 weeks until post-transplant week 13, with a four-to-eight week follow-up period. Earlier efficacy results from completed and ongoing studies reported that CMX001 has the potential to improve outcomes for immunosuppressed patients.
Recently presented data from 183 patients who received CMX001 also indicated that the drug showed no indication of the myelosuppression or nephrotoxicity associated with currently available antiviral therapies. CMX001 is completing Phase II clinical development for the prophylaxis of CMV and is in Phase II development for the preemption and treatment of adenovirus infection in haematopoietic cell transplant recipients.
Chimerix chief medical officer Wendy Painter said CMX001 has the potential to fill the major unmet need and become the standard of care with its broad spectrum coverage of multiple viral infections, favourable safety profile, and convenient oral dosing. "Existing therapies for the prophylaxis and treatment of viral infections, including CMV, in the transplant recipient population are limited by their lack of broad spectrum efficacy and major side effects, notably nephrotoxicity and myelosuppression," she added.
Chimerix president and CEO Kenneth Moch said they look forward to initiating Phase III studies of CMX001 during 2012.
Chimerix is focused on developing novel antiviral therapeutics with the potential to transform patient care in multiple settings, including transplant, oncology, acute care and global health.
Caption: CMV infection of a lung pneumocyte.