Chimerix' Brincidofovir Shows Potential Survival Benefit In Adenovirus Infection

(RTTNews) - Chimerix Inc.(CMRX) announced preliminary data for its investigational antiviral brincidofovir or BCV, CMX001 showing improved survival for patients with adenovirus in the open-label pilot portion of the Phase 3 AdVise Trial.

The company said the preliminary survival analysis data, based on 48 evaluable patients from the ongoing AdVise Trial, showed a mortality rate of 35 percent compared with the historic rates of up to 80 percent mortality in the first month after diagnosis. A majority of subjects also had suppression or clearance of adenovirus from the blood.

There is currently no approved treatment for adenovirus, an infection that can progress rapidly in patients with a weakened immune system due to disease or medications.

Chimerix initiated AdVise in March 2014 based on potency observed in vitro and on clinical data from a Phase 2 trial and a large expanded access trial which showed the potential for improved clinical outcomes. As of September 19th, 48 subjects had enrolled in AdVise, with 35 percent mortality observed to date (17 of 48) with a median duration of observation of 57 days for living patients.

The trial is enrolling pediatric and adult patients with adenovirus infection who receive brincidofovir twice weekly for twelve weeks. Baseline information and at least two months of follow up are available for 26 subjects.

Of those 26 patients, 23 had measurable viral loads at study entry, and three patients had no virus detectable in the blood but had diagnosed adenovirus infection. Fourteen of the 23 patients with viremia at study entry achieved undetectable viral loads during treatment. Twelve of the 26 patients died.

Over half of the subjects were hematopoeitic cell transplant (HCT) recipients with disseminated disease, but solid organ transplant recipients and patients undergoing chemotherapy were also enrolled. Over one-third of the subjects (10 of 26) had a second active infection with another DNA virus in addition to adenovirus, including BK virus (27 percent), cytomegalovirus (19 percent) and Epstein Barr virus (8 percent).

The company noted that the safety and tolerability profile of brincidofovir in these initial subjects was similar to other studies of brincidofovir in immunocompromised patients with complicated medical issues, with only three subjects discontinuing due to adverse events. Of the six subjects who enrolled in the study with adenovirus-related diarrhea, three reported improvement of symptoms and three remained stable.