Durham drug company will give experimental medicine to first-grader Josh Hardy

jmurawski@newsobserver.comMarch 11, 2014 

  • Chimerix at a glance

    CEO: Kenneth Moch

    Founded: 2002 in San Diego. Moved to Durham in 2005.

    Line of business: Drug developer with no drugs on the market. Developing Brincidofovir as a treatment for life-threatening viral infections in patients whose immune systems have been compromised by cancer or drugs.

    Empoyees: 54

    Financial picture: $163 million in losses in 13 years. Raised $117.9 million in April in an initial public offering of stock.

— Durham drugmaker Chimerix made a surprise announcement late Tuesday that it will supply an experimental antiviral drug to treat a 7-year-old child stricken with a potentially fatal virus infection.

The company’s decision will make the medication available to Josh Hardy, a four-time cancer survivor from Virginia who has become a rallying cry for thousands of strangers in the realm of social media.

The Hardy family turned to social media to bring attention to their increasingly desperate plight as Chimerix remained adamant that it would not release the medication selectively under any circumstances, even to prevent death.

The Hardys and supporters had scheduled a caravan to Chimerix’s headquarters in Durham to stage a televised protest against the 54-employee company.

“It was a total surprise for all of us,” said Ben Hardy, Josh’s uncle. “We’re just thankful to Chimerix and the (U.S. Food and Drug Administration) for pulling all this together.”

Chimerix CEO Kenneth Moch said Tuesday the company finalized negotiations with the FDA to provide Josh the drug, Brincidofovir, as part of a drug trial involving 20 people. The talks had been underway since last year, Moch said, but were elevated to a high-priority status when national media organizations reported this week that Josh faced potential death if he didn’t get the Chimerix drug.

Brincidofovir remains unapproved for public use, with unproven benefits and potential risks. It was designed to prevent the onset of adenovirus, not to treat an advanced case of infection. Josh has been infected for about three weeks and is in and out of consciousness.

Hundreds of requests previously denied

Chimerix had previously turned away hundreds of requests for the medication in recent years, including requests from company employees, Moch said.

He told journalists Monday that he would refuse to provide the drug to Josh even if he visited the child at his bedside and saw his deteriorating physical condition.

But on Tuesday, he said Chimerix was never opposed to providing the drug as long as it was available to all patients, under strict ethical protocol, and “not because someone is a friend, or because someone knew somebody, or because somebody made more noise.”

The company negotiated temporary use of Brincidofovir with the Food and Drug Administration. It will be made available for treatment for six months, and Josh, who will begin receiving oral treatments Wednesday, will get two doses per week. The boy is bedridden in St. Jude Children’s Research Hospital in Memphis, Tenn.

Josh became infected with adenovirus, which can cause organ failure and death, after a recent bone marrow transplant to treat leukemia.

Brincidofovir is a potent antiviral under development for the past 13 years. It has won support from federal authorities as an antidote to bioterror attacks. It is the only drug 13-year-old Chimerix is developing, and it’s on a timeline for approval in the second half of 2016 at the earliest.

“Josh Hardy’s story brought to public attention the often-devastating impact of adenovirus infection and helped accelerate a discussion between the FDA and Chimerix regarding the need for additional clinical development to assess brincidofovir’s potential in adenovirus infection,” Chimerix said in a statement. “This study is expected to begin with Josh Hardy as the first patient enrolled on Wednesday, March 12, 2014.”

The special 20-person trial avoids potential ethical problems and other complications of giving the unproven treatment to selective patients.

Chimerix CEO Moch said Monday that providing the drug to Josh exclusively would undermine an ongoing drug trial, in which 450 people will participate but some would get a placebo. Moch said that few patients would agree to risk taking a placebo if the medication was available to them in a “compassionate care” program.

In the trial involving 20 people, all patients will receive the drug, and there will be no placebo.

Murawski: 919-829-8932

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