Chimerix Inc.’s antiviral drug improved survival in patients with adenovirus, according to initial results in a study started after a media storm over emergency use of the drug for a dying boy.
Thirty-five percent of the 48 patients who could be evaluated have died since enrolling in Chimerix’s AdVise trial compared with historic rates of as much as 80 percent mortality during the first month of the infection, the company said Wednesday in a statement. The virus was undetectable in 61 percent of those who received the drug, called brincidofovir, twice weekly for 12 weeks and were followed up for at least two months, according to the data published for the annual meeting of the Infectious Diseases Society of America, which is taking place this week in Philadelphia.
“The big takeaway here is, based on the evidence of the trial we have so far, we halved that mortality,” Garrett Nichols, chief medical officer of Chimerix, said in a telephone interview. “This is the first study to show that there is hope for these patients.”
Adenovirus causes respiratory infections and can be fatal in patients with a weakened immune system. There is no approved treatment.
The AdVise trial was started after the family of Josh Hardy, a 7-year-old boy with cancer who contracted adenovirus after a bone marrow transplant, appealed to Chimerix (Nasdaq: CMRX) for the compassionate use of brincidofovir. Compassionate use refers to providing a drug to fight a disease when the treatment hasn’t yet been approved by regulators for that purpose.
Chimerix, which had closed its compassionate use program after giving the treatment to more than 430 patients, declined to provide it for the boy. The decision generated intense criticism as the boy’s family took to social media to petition the company for the drug.
After receiving death threats, Chimerix’s then-Chief Executive Officer Ken Moch started the AdVise trial on March 12 and enrolled Hardy as the first patient. Chimerix announced on April 9 that Moch had left the company.
While Chimerix had been in talks with the Food and Drug Administration to design its late-stage trial, “the entire episode served to crystallize the discussion and move it forward that much faster,” Nichols said.
A week after receiving the drug, the level of virus in Josh Hardy’s blood had dropped significantly, his mother said in a blog post.
“It worked wonders,” William Burns, Hardy’s uncle, said in a telephone interview. “It reduced his viral load drastically after two doses.”
“It was the only option,” Burns said of his nephew. “The only treatment he was on wasn’t working, and was doing significant damage to his kidneys.”
Brincidofovir, which is taken as an oral tablet, doesn’t harm the liver like current infusion therapies do, said Jo-Anne Young, an infectious disease and transplant physician at the University of Minnesota Medical School, who is helping to run the trial.
Chimerix will continue to enroll as many as 100 patients in the AdVise trial, then review the design of the study for the second half of the trial with the FDA, Nichols said.
Brincidofovir was also used to treat two patients with Ebola. Thomas Eric Duncan, the first person to be diagnosed with Ebola in the United States, died Wednesday at Texas Health Presbyterian Hospital Dallas. Ashoka Mukpo, an NBC freelance journalist, was diagnosed with the disease in Liberia and flown to Nebraska Medical Center in Omaha for treatment.
While the drug is currently in animal trials for Ebola, it hasn’t been tested in humans.