Chimerix has begun patient dosing in a randomised, placebo-controlled study of CMX001, which is being developed as a potential broad spectrum, oral antiviral product for the treatment or prevention of double-stranded DNA viral diseases.
The Phase II AdV HALT Trial is intended to evaluate the safety and efficacy of CMX001 to prevent immunocompromised paediatric and adult patients with asymptomatic adenovirus infection from developing disease.
The randomised, placebo-controlled, multi-site AdV HALT trial, which will be carried out across 30 centres, will enrol 48 paediatric and adult patients who have undergone haematopoietic stem cell transplantation.
The US Food and Drug Administration has granted CMX001 fast-track designation status for the development programme for this indication.
The primary endpoint will be ‘treatment failure’, consisting of progression to AdV disease or increasing AdV viraemia.
Secondary endpoints include safety and tolerability of CMX001, as well as other measurements.