RTP biotechnology firm begins human trials for potential COVID-19 treatment
BioCryst Pharmaceuticals, a publicly traded biotechnology company based in Research Triangle Park, has begun trials on a potential treatment for COVID-19, the disease caused by the novel coronavirus, the company announced.
The trial will investigate whether the company’s experimental yellow fever treatment, named galidesivir, is effective against COVID-19. BioCryst said that the antiviral treatment has already shown some activity against a number of different viruses, including the coronavirus strains that cause SARS and MERS.
The randomized, double-blind, placebo-controlled clinical trial is an offshoot of a continuing trial of galidesivir on yellow fever being done in Brazil. BioCryst said the trial is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
Like the yellow fever trial, the COVID-19 trial will also take place in Brazil under a U.S. investigational new drug application.
John Bluth, head of investor relations and corporate communications at BioCryst, said the previous relationship with NIH is allowing the company to move quickly on COVID-19.
“We had a yellow fever trial in place in Brazil, and sites activated already for the yellow fever trial, so it was quickest to begin there,” Bluth said in an email. “We have begun to see COVID-19 cases in Brazil, and we have a good opportunity to enroll and treat patients earlier in their disease course to determine if galidesivir can benefit patients with COVID-19.”
Brazil has more than 18,000 confirmed coronavirus cases, according to a tracker from Johns Hopkins University.
The first part of the Brazilian trial will include 24 hospitalized adults with COVID-19. The patients will be split into three groups, with six patients in each group getting galidesivir intravenously and the others getting a placebo.
In part two of the trial, BioCryst will work with up to 42 hospitalized patients, who will randomly receive galidesivir or a placebo. All patients will be tracked for mortality for up to 56 days, the company said.
BioCryst has one previous drug approved the U.S. Food and Drug Administration for use. That drug, RAPIVAB, treats acute uncomplicated influenza in patients ages 2 and up.
BioCryst has three other drugs in its pipeline, including one that is meant to treat hereditary angiodema, a rare disease that causes severe swelling in the body.
Bluth said the company’s “first focus is on executing the trial and evaluating galidesivir safety and activity as a treatment for COVID-19 patients.”
“BioCryst and our government partners,” he said, “are working with great urgency during this global health emergency.”
BioCryst has 140 employees, according to filings with the Securities and Exchange Commission. The company had $138 million in cash on hand at the end of 2019, its federal filings showed.
Several companies and researchers in the Triangle, a center for biotechnology, have moved quickly to develop treatments for the coronavirus.
Earlier this week, scientists at UNC-Chapel Hill said they had developed an antiviral drug for COVID-19. The university is moving into human clinical trials for the drug, called EIDD-2801, after it reduced severe lung damage in testing involving mice infected with the coronavirus, The News & Observer reported.
That drug was developed by a team led by Dr. Ralph Baric, who runs a lab at UNC’s Gillings School of Global Public Health that’s working on fighting the global pandemic and finding a cure for the coronavirus disease.
Duke University is participating in a clinical trial for another COVID-19-fighting drug. Duke patients with significant symptoms of COVID-19 will be given the option to participate in the trial for the treatment, an antiviral called remdesivir.
Another Triangle company, the Spanish biotech firm Grifols, is using its large Clayton facility to process blood from recovered COVID-19 patients in an effort to harvest coronavirus-fighting antibodies. The hope is that Grifols can use these antibodies to develop treatments for COVID-19 patients.
This story was produced with financial support from a coalition of partners led by Innovate Raleigh as part of an independent journalism fellowship program. The N&O maintains full editorial control of the work. Learn more; go to bit.ly/newsinnovate
This story was originally published April 10, 2020 at 2:03 PM with the headline "RTP biotechnology firm begins human trials for potential COVID-19 treatment."
