Chimerix Wins FDA OK For Pilot Trial, Will Give Drug To Josh Hardy

Chimerix announced that the U.S. Food and Drug Administration (FDA) has approved the immediate initiation of a pilot trial for brincidofovir for the treatment of adenovirus infections in immunocompromised patients. The agreement with the FDA opens the door for Josh Hardy to obtain access to the potential life-saving drug.

The company recently drew attention when parents of Josh Hardy, a 7-year-old boy who has kidney and heart failure, publicized their plea to get brincidofovir for their son. Chimerix President Kenneth Moch initially refused the request, citing time and resource constraints as the company is pushing for speedy approval and market entry. The company has to spend $50,000 to give the drug to Josh Hardy under the compassionate use arrangement with the FDA.

Now the company will be able to provide patients like Josh Hardy the opportunity to use brincidofovir even before it has been approved by the FDA. Chimerix will work with the federal regulator to design a pivotal Phase III study that will continue the initial pilot study. Josh Hardy is the first patient to be enrolled in the study on March 12.

CEO Kenneth I. Moch said, “This 20-patient open-label study underscores Chimerix's mission to develop innovative antiviral therapies in areas of high unmet need - for everyone. Being unable to fulfill requests for compassionate use is excruciating, and not a decision any one of us ever wants to have to make. It is essential that each individual in a health crisis be treated with equal gravity and value, a principle we have upheld by pursuing further clinical study of brincidofovir that will inform its use in adenovirus and other serious DNA viral infections.”

Brincidofovir is an oral nucleotide analog that has demonstrated broad-spectrum antiviral activity against all five families of DNA viruses including cytomegalovirus (CMV), adenovirus (AdV), BK virus, and herpes simplex viruses. The drug has shown positive safety and tolerability profile with negative evidence of toxicity in the kidney and bone marrow of almost 900 patients who has received brincidofovir treatment to date.

Hervé Momméja-Marin, Vice President of Clinical Research at Chimerix, said "We are pleased to be providing access to brincidofovir in a manner consistent with our focus on progressing clinical development toward a potential regulatory approval that would make it widely available to patients who might benefit from its use. We are grateful to the FDA for their continuous guidance and assistance in expediting brincidofovir's development path forward."