BioCryst Pharmaceuticals, Inc. announced 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.
The goals of this 28-day study were to assess the effect of different dosing regimens of BCX4430 administered by i.m. injection on survival in rhesus macaques with established Ebola virus disease. The study consisted of three treatment groups of six animals each treated with different BCX4430 dosing schedules and one control group of six animals.
“USAMRIID was pleased to work with our partners at BioCryst to advance the understanding of the efficacy of BCX4430. We are encouraged by the favorable results demonstrating significant efficacy of BCX4430 under delayed treatment scenarios,” said Dr. Travis K. Warren, Principal Investigator, 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.”
Following inoculation of virus on Day 0, six of 6 (100%) animals survived after receiving 100 mg/kg BCX4430 twice on day 2, followed by 25 mg/kg twice daily for an additional nine days, compared to none of 6 controls (p < 0.001). Animals treated with the same loading and maintenance dose regimen of BCX4430, but starting on day 3, also showed improved survival (4 of 6, 67%, p = 0.005), as did animals treated with 25 mg/kg of BCX4430 twice daily for 14 days starting on day 2 (4 of 6, 67%, p = 0.005).
“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,” said Dr. William P. Sheridan, SVP and Chief Medical Officer, BioCryst Pharmaceuticals. “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.”
This project is substantially funded with Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), 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, HHSN272201300017C, with a current contract value of $39.5 million if all contract options are exercised. In March 2015, BARDA awarded BioCryst a contract, HHSO100201500007C, for the continued development of BCX4430 as a potential treatment for filovirus diseases with a current contract value of $39.1 million if all contract options are exercised.
BCX4430 is a broad spectrum antiviral in advanced development under the Animal Rule for the first indication of treatment of Ebola virus disease. A Phase 1 clinical safety and pharmacology study 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. BCX4430 has also demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including filoviruses, togaviruses, bunyaviruses, arenaviruses, paramyxoviruses, coronaviruses and flaviviruses. BioCryst is developing BCX4430 in collaboration with U.S. Government Agencies.
Filed Under: Drug Discovery