Congo starts trial of Gilead’s experimental Ebola Bundibugyo antiviral

• The study will enroll approximately 1,000 people aged 12 and older who had high-risk exposure to confirmed Ebola cases within five days but remain asymptomatic, with participants monitored daily for 21 days and final follow-up at 42 days
• The project has secured 3.4 million euros from the Global Health EDCTP3 partnership and European Commission, plus $6 million from Africa CDC, South Africa, and the Democratic Republic of Congo
• A separate compassionate-use protocol will provide Gilead's injectable remdesivir to children under 12 and pregnant or breastfeeding women exposed to the virus

Summary

Researchers in the Democratic Republic of Congo have initiated a clinical trial testing Gilead Sciences' experimental antiviral obeldesivir as a post-exposure treatment for the ongoing Bundibugyo Ebola outbreak affecting Congo and Uganda.

Trial Details:

• Targeting enrollment of approximately 1,000 participants aged 12 and older
• Participants must have had high-risk exposure to confirmed Ebola cases within five days but remain asymptomatic
• Daily monitoring for 21 days, with final follow-up at 42 days
• Led by Congo's National Institute for Biomedical Research and France's ANRS Emerging Infectious Diseases, with support from ALIMA and Médecins Sans Frontières
• Location: Ituri province, the outbreak's epicenter

Funding:

• €3.4 million ($3.87 million) from Global Health EDCTP3 partnership and European Commission
• $1 million from Africa Centres for Disease Control and Prevention
• Additional $5 million secured from South Africa and Democratic Republic of Congo

Scientific Basis:

Obeldesivir has demonstrated activity against filoviruses, including Bundibugyo Ebola virus, in pre-clinical studies.

Additional Protocol:

A separate compassionate-use program will provide Gilead's remdesivir (injectable antiviral) to vulnerable populations: children under 12 and pregnant or breastfeeding women exposed to the virus.

Outbreak Impact:

The current outbreak has resulted in 1,963 confirmed cases in Congo, with 719 deaths reported, according to government data.

Market Implications:

This trial represents a significant development for Gilead Sciences in expanding its infectious disease portfolio beyond its established antiviral franchise, potentially opening new treatment avenues for deadly hemorrhagic fevers in outbreak settings.