- Japanese drugmaker Takeda Pharmaceutical has begun dosing subjects in a Phase 2b efficacy trial of its norovirus vaccine candidate, the only drug currently in clinical development for the highly-infectious intestinal virus.
- The intramuscular vaccine is designed to mimic the outer surface of the norovirus, using virus-like particle antigens. An earlier Phase 1/2 study in 98 patients found the drug to be well-tolerated,although the reduction in vomiting or diarrhea did not reach statistical significance.
- Norovirus is one of the primary causes of acute gastroenteritis, and leads to nearly 200,000 deaths per year, according to a study cited by Takeda.
Norovirus is highly contagious and typically leads to diarrhea, vomiting, and nausea. In some people, these symptoms can lead to clinically significant dehydration, which can be fatal.
According to a study for the Centers for Disease Control and Prevention, norovirus is associated with nearly 20% of all diarrheal disease globally. The study estimated a person can expect to experience illness due to the virus between three and eight times in their life.
As there is no commercially available vaccine, Takeda has high hopes for its candidate, known as TAK-214. "“We are excited to be on the frontline of development of a vaccine against norovirus,” said Rajeev Venkayya, president of Takeda Vaccines.
Takeda plans to enroll 3,400 patients in the Phase 2b trial, which will run through August 2017, reports PMLive.