Positive Ph III results for Takeda's dengue vaccine candidate

Takeda Pharmaceutical’s (TYO: 4502) shares edged up 1.2% to 4,278 b close of Tokyo trading today, after the Japanese drug major announced that results from the primary endpoint analysis of the ongoing pivotal Phase III  Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial of its dengue vaccine candidate (TAK-003) were published in the New England Journal of Medicine.

Takeda’s dengue vaccine candidate demonstrated protection against virologically-confirmed dengue (VCD), the trial primary endpoint, in children ages four to 16 years. Vaccine efficacy (VE) was 80.2% (95% confidence interval [CI]: 73.3% to 85.3%; p<0.001) in the 12-month period after the second dose, which was administered three months after the first dose. Similar degrees of protection were seen in individuals who had and had not been previously infected with dengue based on planned exploratory analyses of secondary endpoints (VE: 82.2% [95% CI: 74.5% to 87.6%] versus VE: 74.9% [95% CI: 57.0% to 85.4%], respectively).

French drug major Sanofi’s (Euronext: SAN) Dengvaxia - the world’s first dengue vaccine - had demonstrated 59.2% overall efficacy in the first year of follow-up based on combined results from two late-stage trials. However, the Sanofi drug has also come under scrutiny as is was found increased the risk of severe dengue in children who had no prior dengue exposure.