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Clinical Trial Underway for Lassa Fever Treatment

Lassa fever investigation

CDC specialist in Nigeria investigating Lassa fever in rat specimens (Mike Blyth, Flickr)

5 September 2018. An early-stage clinical trial is underway to test a treatment for Lassa fever, a viral disease found in West Africa, infecting as many as 300,000 individuals a year. The study is conducted by Kineta Inc., a biotechnology company in Seattle, with funding from the Wellcome Trust Translation Fund.

Lassa fever, according to World Health Organization, was first described in the 1950s, but the virus causing the disease was not identified until 1969. While WHO estimates from 100,000 to 300,000 people each year are infected with Lassa fever, about 80 percent experience no symptoms. Among the remainder, Lassa fever symptoms emerge slowly starting with fever, malaise, and general weakness, followed by more severe symptoms including pain, nausea, and diarrhea. In severe cases, bleeding, facial swelling, and fluid in the lung cavity can occur, with neurological symptoms, such as seizures, disorientation, and hearing loss. In these severe cases, death can occur within 14 days, and is particularly a threat to pregnant women in their third trimester.

The Lassa fever virus is part of the Arenaviridae or Arenavirus family, characterized by a single strand of RNA. The disease is spread largely by the urine and droppings of rats in West Africa. Cases of Lassa fever were first reported in Nigeria, in a town named Lassa, but more cases are since reported as well in Benin, Ghana, Guinea, Liberia, Mali, and Sierra Leone.

Kineta creates antiviral treatments that pose biological warfare threats, of which Lassa fever is one. The company developed an antiviral treatment code-named LHF-535, a small-molecule or low molecular weight therapy for Lassa fever and other arenavirus diseases. LHF-535 prevents the virus from entering host cells and stops replication of the virus. Kineta says in preclinical tests with animals induced with Lassa fever, LHF-535 reduced viral loads, increased survival rates, and was well tolerated.

The clinical trial, says the company, is designed to test the safety of LHF-535 in healthy adults, as well as determine safe dosage levels and track actions of the drug in the body. A total of 56 participants are being recruited, broken into groups of 8 individuals testing a single dose of the drug in various sizes. The study is expected to be completed in the first quarter of 2019, followed by a second trial testing multiple doses of LHF-535.

Kineta says it anticipates LHF-535 will be eligible for a tropical disease priority review voucher, a program of the U.S. Food and Drug Administration, that allows for expedited review of treatments for certain rare or dangerous tropical diseases. Lassa fever was added to the list of eligible diseases in August 2018.

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