BioCryst Pharmaceuticals of Durham has reported positive results from a proof-of-concept study of its broad-spectrum antiviral BCX4430 for the delayed treatment of Ebola virus infection in rhesus macaques.
“These study results add to the growing body of evidence of the potential utility of BCX4430 for treatment of a broad range of serious emerging viral infections, including Ebola virus disease and Zika virus disease,” William Sheridan, senior vice president and chief medical officer of BioCryst, said in a company news release. “We look forward to completing the studies required to satisfy requirements for Emergency Use Readiness and full regulatory approval of this novel broad-spectrum antiviral drug.”
The goals of the 28-day study were to assess the effect of different dosing regimens of BCX4430, administered by intramuscular injection, on survival in rhesus macaques with established Ebola virus disease.
Treated animals withstand Ebola challenge
The study involved 24 animals: three treatment groups of six animals each that were treated with different BCX4430 dosing schedules, and one control group of six animals.
All six of the animals that began receiving the strongest treatments two days after they were inoculated with Ebola survived, while none of the six untreated animals did.
Other animals that were treated a day later or with weaker doses also showed better survival than the control group, with eight of 12 animals surviving.
The testing was done in partnership with scientists at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) in Fort Detrick, Md. The institute is the Department of Defense’s lead laboratory for medical biological defense research, and its work leads to vaccines, drugs, diagnostics and information that benefit both military personnel and civilians.
“We are encouraged by the favorable results demonstrating significant efficacy of BCX4430 under delayed treatment scenarios,” said Travis Warren, a principal investigator at USAMRIID. “The available human safety data and new efficacy data position BCX4430 as a highly promising therapeutic that could potentially be used to treat people with Ebola virus disease when future outbreaks arise.”
Federal funding helps drive company’s research
This project is substantially funded by the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health and the Department of Health and Human Services and the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.
In September 2013, NIAID awarded BioCryst a contract for the development of BCX4430 as a potential treatment for filovirus diseases. The contract is valued at $39.5 million if all its options are exercised, the company said.
In March 2015, BARDA awarded BioCryst a contract for the continued development of BCX4430 with a current value of $39.1 million if all options are exercised.
A phase one clinical safety and pharmacology study of BCX4430 in healthy subjects has been completed, and in animal studies, BCX4430 has demonstrated survival benefits against a variety of serious pathogens, including Ebola, Marburg, Yellow Fever and Zika viruses, the company said.
BCX4430 has also demonstrated broad-spectrum activity in “test tube” experiments against more than 20 RNA viruses in nine different families, including filoviruses, togaviruses, bunyaviruses, arenaviruses, paramyxoviruses, coronaviruses and flaviviruses.
Founded in 1986, BioCryst is a publicly traded company with about 70 employees at its Durham headquarters near Research Triangle Park, and at its research center in Birmingham, Ala. The company focuses on developing novel therapeutics for rare and serious diseases.
(C) N.C. Biotechnology Center