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Long-term studies reaffirmed Takeda’s potential dengue vaccine candidate

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Tomohiro Takeda Yoshinori Ohsumi / Getty Images

Yoshinori Ohsumi / Getty Images

Takeda Has been promoting the potential of dengue vaccines for several years, and new long-term data confirm the potential of drugs to prevent deadly mosquito-borne viruses.

The company has announced the first public announcement of long-term safety and efficacy results from the ongoing and critical Phase III dengue efficacy trial (TIDES) trial of TAK-003, a candidate for dengue vaccine. ..The· 36 months of dataIncluded in the regulatory filing, has demonstrated that the vaccine provides continuous protection against hospitalization for dengue fever.

Takeda’s data showed that the vaccine provided 83.6% protection for hospitalization needs and 62% overall efficacy against the virus. The level of protection has nothing to do with the individual’s previous exposure to dengue. The company presented data on weekend long-term studies at the 17th International Travel Medicine Society.

TAK-003 was generally well tolerated and no significant safety risks were observed. This result enhances the potential of TAK-003 to help protect people who live in or travel to dengue endemic countries.

Derek Wallace, Takeda’s global dengue program leader, said the vaccine candidate continued to provide protection against the virus for three years after administration. The data showed that TAK-003 was “especially robust to prevent hospitalization,” he said. Wallace said he was confident that TAK-003 could handle the “significant global burden of dengue fever” with strong results.

Dengue is the most rapidly prevalent mosquito-borne viral disease, with an estimated 390 million cases and 500,000 hospitalizations worldwide annually, limiting prevention options. The World Health Organization has included dengue fever as one of the 10 threats to global health in 2019.

According to Takeda, about half of the world is under threat from dengue fever, which is estimated to cause 390 million infections and about 20,000 deaths worldwide each year.

TAK0-003, a candidate for a tetravalent live dengue vaccine, is based on the live attenuated dengue serotype 2 virus. In Phase I and II trials, vaccinated children and adolescents showed an immune response to all four dengue serotypes.

In 2019, the company Release Phase III data This indicates that the double dose treatment has reached the primary and secondary endpoints. With long-term data now at hand, the company is looking at potential regulatory approvals.

Based on both adult and pediatric data, Takeda seeks indications for TAK-003 for the prevention of dengue in individuals aged 4 to 60 years, regardless of previous viral exposure.

The company is currently seeking approval for TAK-003 in the European Union and countries where dengue is endemic. Takeda plans to seek approval in the United States later this year.

If approved, TAK-007 will challenge Sanofiof Dengvaxia, a dengue vaccine with a history of problems, especially in the Philippines.

In 2017, the dengue vaccine Actually worsens the symptoms of the disease For those who have never been exposed to the virus before. Sanofi said the analysis revealed that more severe conditions could occur after treatment of patients who had not previously been infected with the dengue virus. The Philippines has stopped using the dengue vaccine in that country.

Lak Kumar Fernando, MD, Physician at the Center for Dengue and Hemorrhagic Fever in Sri Lanka and Principal Investigator for the TIDES trial, said: In the statement. “The results of Takeda’s long-term analysis of dengue vaccine candidates suggest that it may help prevent outbreaks, reduce hospitalization rates, and protect people from dengue, regardless of previous exposure. In particular, no significant safety risks were identified. “

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