Drug Development Phase: Pre-clinical
The recent outbreaks of Zika virus and Ebola highlight the risks posed by emerging viruses and the need to develop effective medical countermeasures. Arenaviruses like Lassa fever also pose a significant global health threat in endemic regions of the world as well as a biodefense threat in developed nations.
LHF-535 is a small molecule antiviral with potent activity against Lassa and other arenaviruses. It inhibits virus entry into target host cells and serves to suppress viral replication. LHF-535 is an optimized lead compound with good oral bioavailability and pharmacokinetics, supporting once-daily administration. It has demonstrated safety and efficacy in preclinical models, including reduced virus titers and enhanced survival in animal models of arenavirus pathogenesis. A clear development path for LHF-535 was established after a successful pre-IND interaction with FDA in mid-2015. There is a significant unmet need as there are currently no therapeutics or vaccines that are indicated for patients with Lassa fever.
Lassa fever is an acute viral illness that is known to be endemic in Benin, Guinea, Liberia, Sierra Leone and parts of Nigeria, but probably exists in other West African countries as well.1 Lassa fever causes 100,000-300,000 infections and is responsible for ~5000 deaths annually in West Africa. Death rates are particularly high for women in the third trimester of pregnancy and fetal loss occurs in nearly all infected pregnant women.2 The Lassa virus is transmitted to humans via contact with food or household items contaminated with rodent urine or feces. Person-to-person transmission also occurs, particularly in hospitals lacking adequate infection control measures.1
Kineta is receiving funding from the Wellcome Trust to advance LHF-535 through Phase I human safety studies.
1. WHO Lassa Fever Fact Sheet http://www.who.int/mediacentre/factsheets/fs179/en/
2. CDC Lassa Fever Fact Sheet http://www.cdc.gov/vhf/lassa/pdf/factsheet.pdf