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First Clinical Trial Launched for Yellow Fever Treatment Candidate

DEC 06, 2018 | MICHAELA FLEMING
Updated: 12/6/2018 at 8:44 AM EST

The first patient was dosed in the first in-human clinical trial evaluating a candidate drug (TY014) for the treatment of yellow fever. To date, no biologics or small molecules developed for the treatment of yellow fever have advanced to clinical trials.

TY014, is a monoclonal antibody that is being developed by Tychan, a Singapore-based company, to target the envelop protein on the surface of the yellow fever virus to prevent viral replication by limiting viral fusion to host cells.

The investigators anticipate that the monoclonal antibody could be administered to individuals infected with yellow fever virus to reduce the severity of the disease. Nearly 15% of individuals who are infected will develop serious illness which can include hemorrhage, jaundice, and shock. From this population, approximately 30% die.

To evaluate the effectiveness of the monoclonal antibody in reducing disease severity, the investigators will enroll approximately 67 healthy volunteers. The participants will be split into 2 groups to test the safety and tolerability of TY014 and its effectiveness as an antiviral drug, as well.

The trial will be conducted by SingHealth Investigational Medicine Unit, led by Associate Professor Jenny Low, MBBS, MRCP, MPH, senior consultant, department of infectious diseases, Singapore General Hospital and co-director, Viral Research and Experimental Medicine Centre@SingHealth Duke-NUS (ViREMiCS).

“We plan to complete safety assessments of TY014 in Singapore in healthy volunteers such that once safety for a certain dose is established, this dose can be tested in patients with yellow fever for tolerability and efficacy,” Ooi Eng Eong, PhD, MBMS, FRCPath, professor and deputy director of the emerging infectious disease program at Duke-National University of Singapore (Duke-NUS) and an investigator on the clinical trial told Contagion®. “In addition,  we are actively determining how TY014 can be used to complement the limited doses of yellow fever vaccine in an emergency response should yellow fever virus spread beyond the forests of South America and Africa where it is endemic.” 

Yellow fever causes an estimated 200,000 infections and 30,000 deaths annually in South America and Africa, according to the US Centers for Disease Control and Prevention. Although an approved highly effective vaccine against yellow fever is available, supplies are notoriously mired by shortages, especially during outbreaks.

Between July 2017 and June 2018, 1376 cases of yellow fever and 483 deaths were reported in Brazil. According to an epidemiologic report, the virus spread to several regions of the country where it has not been reported for decades, including the east coast and Atlantic Forest biome region, where a diverse population of nonhuman primates and potential wild vectors reside. The Brazilian outbreak has sparked great concerns that yellow fever could potentially become an urban epidemic.

According to a press release issued by Tychan and partner WuXiBiologics, the current timeline for the vaccine aims to complete safety assessments of TY014 in time to intervene if there is a yellow fever outbreak in early 2019.
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