The US Department of Health and Human Services (HHS) announced today that it has awarded BioCryst Pharmaceuticals a $12 million grant to continue development of BCX4430, a small-molecule drug designed to treat Ebola and other filovirus infections, and to prepare for large-scale manufacturing of the agent.
Studies in nonhuman primates suggest that the drug is effective against Ebola and Marburg viruses and could be useful as a broad-spectrum antiviral, the HHS said in a statement. BCX4430 is currently in phase 1 human trials, and if results show safety, it could be one of the treatments to be tested for efficacy in clinical trials.
Contract details, scale-up plans
The contract was awarded by the HHS' Assistant Secretary for Preparedness and Response with support from the Biomedical Advanced Research and Development Authority (BARDA). Initial funding will cover the next 18 months of work, and the contract could be extended through August 2017 and total about $35 million.
While studies are under way, the contract will support efforts to increase produce yield, reduce process steps, and increase manufacturing scale-up, the HHS said.
BARDA director Robin Robinson, PhD, said in the statement that developing drugs and vaccines against Ebola has been a long-term US goal. "We are making progress quickly to develop product candidates for clinical evaluation and to make products available that protect against this virus," he said.
BCX4430 is the first small-molecule Ebola treatment that BARDA has supported. Other Ebola products in development that have received BARDA funding include the monoclonal antibody cocktail ZMapp and three vaccines.
BioCryst, based in Durham, N.C., said in its statement today that the BCX4430 produced under the contract is expected to be used in clinical studies and nonclinical toxicology studies to support filing for Food and Drug Administration approval for intravenous and intramuscular formulations.
The HHS said that if any of the drugs or vaccines are safe and effective, BARDA could consider purchasing them through Project Bioshield to include in the US Strategic National Stockpile.
The contract announced today is the US government's second to support BXC4430 development, BioCryst said. In September 2013 the National Institute of Allergy and Infectious Diseases (NIAID) awarded a contract for early development work, including the phase 1 study, which launched in December 2014 with results expected in the third quarter of this year.
Infected American's condition improves
In other US Ebola developments, the condition of a US health worker who was infected with Ebola while serving in Sierra Leone has been upgraded from serious to fair, according to a statement yesterday from the National Institutes of Health (NIH) Clinical Center in Bethesda, Md., where the patient is being treated.
The patient was evacuated from Sierra Leone and hospitalized at the NIH Clinical Center on May 13. No official details are available about the individual, who was working with Partners in Health (PIH). Several other health workers were also potentially exposed and brought back to the United States or their home countries for monitoring. Five days ago the NIH upgraded the patient's status from critical to severe.
Paul Farmer, MD, cofounder and chief strategist for PIH, said in a statement yesterday that news of the patient's improvement is heartening. "We're deeply grateful for the superb critical care he received when he needed it and for the supportive care—supportive in every sense—he continues to receive from the wonderful team at NIH," Farmer added.
Guinea border closure, case count
As part of a 45-day health emergency to further curb the spread of Ebola, Guinea closed its border with Sierra Leone yesterday, the Associated Press (AP) reported.
President Alpha Conde has said the 45-day health emergency would apply to five districts that are hot spots, some of which are on the border with Sierra Leone, according to the report.
Meanwhile, the World Health Organization (WHO) said today that the number of confirmed, probable, and suspected cases in the three countries has risen to 25,178, which includes 10,445 deaths.
The totals reflect an increase of 148 illnesses and 47 deaths over the WHO's updated numbers yesterday and include data reported from all three countries as of Mar 29.
Mar 31 BioCryst press release
Mar 31 HHS press release
Mar 30 NIH press release
Mar 30 PIH statement
Mar 30 AP story
Mar 31 WHO update