Novavax (NVAX) announced that it has started the enrollment process of a phase II study (n=1,600) to evaluate its pipeline candidate – a respiratory syncytial virus (RSV) F-protein nanoparticle vaccine – in healthy subjects aged above 60 years. The news pleased the investors as shares of the company climbed 6.15% to close the trading session on Oct 14 at $4.49.
The randomized, observer-blinded, placebo-controlled study will enroll patients across 10 sites in the U.S. It aims to assess the incidence of all respiratory diseases caused by RSV, including medically-attended respiratory illnesses and hospitalizations for respiratory illness in community-living elders treated with placebo. The study also intends to evaluate the safety and immunogenicity of the vaccine (135ug) compared with placebo. Moreover, Novavax will assess the efficacy of the candidate in bringing down the incidence of RSV-caused respiratory illnesses.
The RSV market is characterized by significant unmet medical need and offers significant commercial potential. Novavax stated in its press release that approximately 11,000 to 17,000 elders and high risk adults succumb to RSV infection or its complications every year in the U.S. Moreover, up to 180,000 people are hospitalized with serious respiratory symptoms. We note that Gilead Sciences (GILD) is also developing a candidate targeting the RSV market.
Novavax is actively developing its pipeline. Last month, the company announced encouraging top-line data from a dose-ranging phase I/II study on its H7N9 avian influenza virus-like particle (VLP) vaccine candidate, H7N9 VLP. We expect investor focus to remain on updates regarding Novavax’s pipeline, going forward.
Novavax carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care space include Medivation (MDVN) and Emergent BioSolutions (EBS). Both stocks sport a Zacks Rank #1 (Strong Buy).
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