Takeda Pharmaceutical announced that it will soon unveil in a peer-reviewed journal the complete details of the results from its late-stage trial evaluating the safety and efficacy of its experimental dengue vaccine TAK-003 in children who previously had dengue and those who had not. Takeda said the vaccine appeared to be safe and effective for all four dengue strains, based on data from blood samples collected from 20,000 participants in its TIDES trial from Asia and Latin America ages 4 to 16.
Apellis Pharmaceuticals' complement factor C3 inhibitor APL-2, being developed to treat geographic atrophy, received fast-track designation from the FDA. The company intends to launch a late-stage study of the drug this year.
An FDA fast-track designation was granted to PaxVax for its vaccine that is being developed to prevent chikungunya virus-caused disease. The company anticipates results from a Phase IIb dose-finding trial of the vaccine early next year.
Concert Pharmaceuticals' CTP-543, which is being developed as a treatment for patients with moderate to severe alopecia areata, was given fast-track designation by the FDA. The treatment is in a midstage study.
Takeda Pharmaceutical launched an early-stage trial to evaluate TAK-426, its Zika virus vaccine candidate. Preliminary data from the Phase I study is expected to become available in 2018, with the goal of initiating Phase II studies as soon as possible if positive results are obtained.