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| Chimerix CEO Kenneth Moch |
On Tuesday morning, Chimerix CEO Kenneth Moch was at the center of a media storm, maintaining that there was no way the biotech could responsibly provide its experimental antiviral to a dying child named Josh Hardy, a drug the boy's parents vowed was all that could save the child's life. By Tuesday night, though, Moch had found a way to give the treatment to the 7-year-old after all, as part of the clinical development program for the drug.
According to Moch, the FDA has agreed to let Chimerix ($CMRX) immediately launch a pilot trial of open-label brincidofovir for adenovirus infections in immunocompromised patients. Hardy will be the first patient provided the therapy on Wednesday morning. And the company says that regulators have agreed to help design a pivotal Phase III study that could be launched as a continuation of this pilot.
A battery of national media groups like CNN, Fox and USA Today churned up a blizzard of stories about Hardy's plight, putting Moch--and his protests that the company couldn't provide the drug under a compassionate use program without triggering hundreds more such demands--under intense scrutiny. But instead of throwing in the towel and simply handing over the therapy, he went for the "pilot" compromise to put an end to the controversy.
"Being unable to fulfill requests for compassionate use is excruciating, and not a decision any one of us ever wants to have to make," Moch said in a statement. "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," Moch says.
Moch remains in a tight spot. The company, which is publicly traded, has said it can't commit to a charitable program to give the drug away to desperate patients because it couldn't afford the cost. But the media storm was a public relations disaster, making the company look indifferent to a child's last hope of staying alive. Satisfying its financial responsibilities to stay focused on R&D and gaining public trust about its priorities takes some finesse.
Biotechs, of course, don't design drug studies and recruit patients this way. The boy is extremely sick and may not respond, raising questions about what Chimerix is developing. And what happens when the next compassionate use case hits the headlines? There is a limit to the number of pilot studies that can be launched. But as long as the focus is on this boy and his fate, none of that matters so much.
- here's the release
Editor's Corner: The dying child vs. the biotech: Everybody loses