RESEARCH TRIANGLE PARK, N.C., Dec. 22, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that data from part 1 of a clinical trial of its broad-spectrum antiviral, galidesivir, showed that galidesivir was safe and generally well tolerated in patients infected with SARS-CoV-2, the virus that causes COVID-19. The trial was not designed or sized to demonstrate clinical efficacy and no clinical efficacy benefit with galidesivir treatment compared to placebo treatment was observed in the trial.
Based on the company’s ongoing discussions with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, a major funding partner for the program, BioCryst expects NIAID to continue their support for the development of galidesivir with a focus on biodefense threats, such as Marburg virus disease, and to discontinue the pursuit of a COVID-19 indication for galidesivir.
“We are encouraged by the first patient data with galidesivir and the growing body of evidence that galidesivir could be an important broad-spectrum antiviral. We appreciate the government’s continued investment to investigate galidesivir as a biodefense drug,” said Jon Stonehouse, chief executive officer of BioCryst.
BioCryst is engaged in ongoing discussions with NIAID to define specific further galidesivir studies that NIAID would support.
Part 1 Trial Design
Part 1 of the trial enrolled 24 hospitalized adults diagnosed with moderate to severe COVID-19 confirmed by PCR. Three cohorts of eight patients were randomized to receive intravenous galidesivir (n=6) or placebo (n=2) every 12 hours for seven days.
Each dosing regimen began with a single 10 mg/kg or 20 mg/kg loading dose, followed by a maintenance dose of 2 mg/kg or 5 mg/kg administered twice daily. The three dosing regimens evaluated were 10 mg/kg then 2 mg/kg (cohort 1), 10 mg/kg then 5 mg/kg (cohort 2) and 20 mg/kg then 5 mg/kg (cohort 3).
The trial was conducted in Brazil under a U.S. investigational new drug application. The protocol also was approved by the Agência Nacional de Vigilância Sanitária (ANVISA) and the Brazilian National Ethics Committee (CONEP).
Part 1 Results
The primary objective of part 1 of the dose-ranging study was to evaluate the safety of galidesivir. No safety signals were identified, and all three dose levels were equally safe.
Secondary objectives were to evaluate the effect of galidesivir on the clinical course of COVID-19 and on SARS-CoV-2 infection in the respiratory tract.
Galidesivir treatment was associated with a more rapid decline in viral RNA levels in the respiratory tract in an apparent dose-dependent manner.
A separate study of galidesivir in a COVID-19 animal model showed that early administration of galidesivir reduced SARS-CoV-2 viral burden in lung tissue (1.4-1.6 log lower tissue viral burden) and was associated with a significant reduction in damage to lung tissue, compared to vehicle control treated animals. These results suggest that early antiviral treatment of SARS-CoV-2 infection may protect against developing severe COVID-19 lung disease.
NIAID is a major funding partner of the galidesivir program under contracts 75N93020C00055 and HHSN272201300017C.
About Galidesivir (BCX4430)
Galidesivir, a broad-spectrum antiviral drug, is an adenosine nucleoside analog that acts to block viral RNA polymerase. It is in advanced development for the treatment of Marburg virus disease. In animal studies, galidesivir has demonstrated activity against a variety of serious pathogens, including, Ebola, Marburg, Yellow Fever and Zika viruses. Galidesivir has also demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including coronaviruses, filoviruses, togaviruses, bunyaviruses, arenaviruses, paramyxoviruses, and flaviviruses. BioCryst is developing galidesivir in collaboration with U.S. government agencies and other institutions.
Direct naar Forum