RESEARCH TRIANGLE PARK – Durham-based BioCryst Pharmaceuticals will conduct a clinical trial in Brazil to see if its investigational anti-viral drug is effective in treating the COVID-19 coronavirus.
The therapy, galidesivir, will be used in a two-phase study of hospitalized adults who have moderate to severe COVID-19 infections.
Galidesivir is a broad-spectrum antiviral drug that acts to block viral RNA polymerase, an enzyme that synthesizes RNA from DNA. BioCryst says the medication has shown potential as a treatment for more than 20 RNA viruses in nine different families, including the coronaviruses that cause Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS).
The randomized, double-blind and placebo-controlled clinical trial will be conducted under a U.S. investigational new drug application. Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) and the Brazilian National Ethics Committee have approved the trial protocol.
The National Institute of Allergy and Infectious Diseases (NIAID), a unit of the U.S. National Institutes of Health, is funding the study.
“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,” said Esper Kallas, M.D., Ph.D. Kallas – an infectious disease specialist and professor at the University of São Paulo’s School of Medicine – will serve as the clinical trial’s principal investigator.
The first part of the study will involve three groups of eight patients randomized to receive intravenous galidesivir or a placebo every 12 hours for seven days, BioCryst said.
When that phase of the trial is complete, investigators will select the best dosing regimen. Initial results will be measured in terms of safety, time to clinical improvement, hospital discharge, and time to undetectable levels of the virus, as well as mortality from all causes.
A second phase will involve up to 42 hospitalized patients randomized to receive galidesivir or a placebo. The study will follow all patients for 56 days and measure the mortality rate.
“Galidesivir has been safe and well-tolerated in Phase 1 studies and, as a potent broad-spectrum antiviral medicine, we are hopeful that we will see a benefit in patients with COVID-19,” said Dr. William Sheridan, BioCryst’s chief medical officer. “This trial is part of the scientific community’s effort to urgently find effective treatments for patients in this global health emergency.”
BioCryst said its overall galidesivir development program has been supported primarily by federal funds from NIAID and the Biomedical Advanced Research and Development Authority, a unit of the Department of Health and Human Services.
The company said the drug has demonstrated potential as a treatment for a variety of serious diseases, including Ebola, Marburg, Yellow Fever, Zika and coronaviruses.
BioCryst moved its headquarters to Durham from Birmingham, Alabama in 2010. It discovers small-molecule medicines that treat rare diseases for which there is a significant unmet need. The company focuses on illnesses in which enzymes play a key role in the biological pathway.