Barely a month after reporting promising Phase II results for its respiratory syncytial virus (RSV) jab and netting an $89 million Gates Foundation grant, Gaithersburg, MD-based Novavax ($NVAX) is going full steam ahead, initiating a Phase III trial for its RSV candidate.
The randomized, observer-blinded, placebo-controlled trial will enroll up to 11,850 older adults at 60 sites in the U.S., the company announced on Monday. The participants will be vaccinated ahead of the 2015-2016 RSV season, with top-line results expected in the second half of 2016.
The trial's objective is to prevent moderate-to-severe lower respiratory tract disease caused by RSV. The objectives and endpoints were designed based on FDA feedback from the End of Phase II meeting.Novavax CEO Stanley Erck
"The primary objective of this clinical trial captures moderate-severe RSV disease that drives an estimated annual economic burden of more than $24 billion in the United States alone," said Novavax CEO Stan Erck in a statement. "The Resolve trial takes Novavax one step closer to bringing this important vaccine to licensure, years ahead of other RSV vaccine development efforts."
Novavax's RSV jab was fast-tracked by the FDA in November 2014, and it has conducted clinical trials in vulnerable populations, including older adults and infants via maternal immunization.
The quest for a vaccine against RSV has been a priority for decades, with the likes of Bavarian Nordic and AstraZeneca's ($AZN) MedImmune racing to develop a vaccine. The former kicked off a Phase I trial for its RSV candidate in August, while the latter had its own candidate fast-tracked by the FDA in April. It is especially important for AstraZeneca to bridge this gap since its blockbuster Synagis, a monoclonal antibody for use in limited RSV cases, went off patent last month.
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