North Carolina-based BioCryst Pharmaceuticals (NASDAQ:BCRX) has announced open enrollment into a phase 1 clinical trial (NCT03891420) evaluating the clinical efficacy and overall safety of their investigational broad-spectrum antiviral drug medication galidesivir for the treatment of COVID-19.
The randomized, double-blind, placebo-controlled trial is being conducted with funding from the National Institute of Allergy and Infectious Diseases (NIAID), a branch of the National Institutes of Health.
Previous phase 1 human studies with healthy subjects demonstrated Galidesivir to be safe and well tolerated, and in vitro analyses have shown that the drug has “broad-spectrum activity against more than 20 RNA viruses in nine different families, including the coronaviruses that cause MERS and SARS.”
The clinical trial will be conducted in Brazil under a United States investigational new drug application and assess treatment efficacy by measuring all-cause mortality, time to clinical improvement, time to hospital discharge, and time to undetectable levels of SARS-CoV-2 based on polymerase chain reaction (PCR) analysis of respiratory specimens. SARS-CoV-2 is the coronavirus that causes COVID-19.
The Agência Nacional de Vigilância Sanitária (ANVISA) and the Brazilian National Ethics Committee (CONEP) have approved the protocol of the clinical trial, which is anticipated to enroll 24 hospitalized adults diagnosed with laboratory-confirmed moderate-to-severe COVID-19.
“Three cohorts of eight patients will be randomized to receive intravenous (IV) galidesivir (n=6) or placebo (n=2) every 12 hours for 7 days. Upon completion of part 1 of the trial, an optimized dosing regimen of galidesivir will be selected for part 2 of the trial, based on part 1 results including safety, viral load reduction in respiratory tract secretions, improvement in COVID-19 signs and symptoms and clinical manifestations, and mortality.”
“In part 2 of the trial, up to 42 hospitalized patients with COVID-19 will be randomized 2:1 to receive IV galidesivir or placebo. After treatment, the patients will remain hospitalized until resolution of COVID-19 symptoms allows release. All patients will be followed for mortality through Day 56,” BioCryst stated.
Chief medical officer of BioCryst Dr. William Sheridan stated, “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. This trial is part of the scientific community’s effort to urgently find effective treatments for patients in this global health emergency.”
“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 Dr. Esper Kallas, principal investigator of the galidesivir trial and infectious diseases specialist and professor of medicine at the School of Medicine, University of São Paulo.
Galidesivir functions as an inhibitor of viral RNA polymerases by mimicking adenosine nucleosides and has been developed for the treatment of the viruses that cause COVID-19, Marburg virus disease, and Yellow Fever.
According to BioCryst, “Phase 1 clinical safety and pharmacokinetics trials of galidesivir by both intravenous and intramuscular routes of administration in healthy subjects have been completed. 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.”
The NIAID and Biomedical Advanced Research and Development Authority (BARDA) have provided funding for the development of galidesivir since September of 2013 and March 2015, respectively, as a potential therapy for Ebola and Marburg virus infection.
Gilead Sciences has also produced a potential SARS-CoV-2 inhibitor, Remdesivir, that has been evaluated in phase 3 clinical trials. Vir Biotechnology is developing a neutralizing antibody against the virus. Vaccines against the virus that causes COVID-19 are under development by multiple biotechnology companies including Moderna, iBio, Inovio Pharmaceuticals, Heat Biologics, Dynavax, and Novavax, among others.