BioCryst Pharmaceuticals has begun enrolling COVID-19 patients in a clinical trial of its antiviral drug galidesivir. The trial builds on in vitro evidence that the adenosine nucleoside analog is effective against pathogens including the MERS and SARS coronaviruses.
Over the past seven years, BioCryst has received government funding to develop galidesivir, also known as BCX4430, as a treatment for infectious diseases. The funding supported a trial in healthy volunteers and was set to enable BioCryst to run a phase 1 study in patients with yellow fever.
Now, BioCryst, like other antiviral developers, is switching its attention to the SARS-CoV-2 virus that is causing COVID-19. BioCryst said the clinical trial is taking place under a ClinicalTrials.gov listing that was originally filed to assess the pharmacokinetics, safety and efficacy of galidesivir in yellow fever.
The first part of the trial will enroll 24 hospitalized adults with moderate-to-severe COVID-19 and divide them up into three cohorts. Six patients in each cohort will receive galidesivir intravenously twice a day for a week. The other two patients in each cohort will receive placebo.
Based on the results from the first part of the trial, BioCryst will select a galidesivir dosing regimen for the second part of the study. In the second part, BioCryst will enroll 42 patients and randomize two-thirds of them to receive galidesivir. BioCryst will track mortality out to day 56.
The trial is enrolling patients in Brazil, reflecting the fact that in its original guise it needed to take place in a country where yellow fever is endemic. In keeping Brazil at the heart of the trial, BioCryst has positioned itself to recruit subjects in a country with a fast-growing need for COVID-19 therapies.
Brazil has registered around 2,000 new COVID-19 cases a day in recently, moving the total quickly toward 20,000. The number of deaths has gone from around 200 at the start of the month to nearly 1,000 today. If the current rate at which deaths are doubling continues, the number of people killed by the virus could reach 6,000 by the end of April.
Relatively few drug developers are currently testing treatments for COVID-19 in Brazil. Of the 410 COVID-19 studies listed on ClinicalTrials.gov, five feature trial sites in Brazil. BioCryst is working with doctors in São Paulo, the current focal point of the Brazilian outbreak, on its study.