Novavax rides high on crest of RSV vaccine wave
The vaccine development company Novavax has announced positive top-line data from a mid-stage clinical trial of its candidate vaccine against respiratory syncytial virus (RSV) in older adults.
The company says RSV F-protein recombinant nanoparticle vaccine candidate, (RSV F Vaccine), was well tolerated and met the trial’s primary, secondary and exploratory objectives.
RSV is a virus that causes a respiratory illness. In people at high risk of illness or complications, such as the elderly and adults with underlying chronic heart or chest disease, RSV can cause more serious illness and death. It is estimated that 2.4 million adults 65 years of age or older are infected with RSV annually in the US, leading to as many as 900,000 medical interventions and 14,000 deaths each year.
Currently, there is no approved RSV vaccine available, although MedImmune and AbbVie’s Synagis (palivizumab) is used for prophylaxis against RSV disease in high risk infants. Previous attempts to create inactivated vaccines in the 1960s were abandoned due to safety concerns.
This would be the first trial to register a positive effect for an RSV vaccine in any clinical trial population. The Novavax trial was a Phase II trial of 1,600 adults aged over 60 in the United States. Half received the 135 microgram dose of the vaccine while the other half received a placebo.
The vaccine showed statistically significant 44% efficacy in preventing all symptomatic RSV disease and 46% efficacy against RSV disease with symptoms of lower respiratory tract infection. It was 64% effective against more severe RSV illness.
“These efficacy data represent a historic advance for the field,” says Gregory Glenn, senior vice president of R&D at Novavax. “This is also an important confirmation of the burden of RSV disease in older adults and highlights the high rate of lower respiratory tract symptoms in those infected by RSV in a large, prospective trial.
“It is clear that our RSV F Vaccine provided statistically significant efficacy in older adults, a population that historically has been difficult to protect. The reduction in symptomatic RSV, RSV with lower respiratory tract illness and RSV associated with difficulty breathing are breakthrough results. We look forward to making details of these data public at an appropriate forum in the future.”
“The development of an RSV vaccine has been a decades-long challenge,” says Stanley Erck, Novavax’s president and chief executive. “We are thrilled by the groundbreaking efficacy of our RSV F Vaccine in older adults. We are committed to pursuing an aggressive developmental timeline for this program which includes discussions with regulatory authorities and initiation of a pivotal Phase III trial as early as the fourth quarter of this year. We also expect to announce safety and immunogenicity data from the RSV F Vaccine Phase II trial to protect infants via maternal immunisation later this quarter.”
“It could be a major breakthrough,” says Dr Andrew Pavia, a spokesman for the Infectious Diseases Society of America and a professor of paediatrics at the University of Utah. But the industry would look to see the preliminary results duplicated in more people, he says, adding: “It’s not time to break out the champagne.” The moderate efficacy results could still be clinically meaningful, Dr Pavia says. “Moderate efficacy, which is the 40-60 percent range, could make a big difference.”
Other companies are further behind in the development of an RSV vaccine; GSK has a candidate in Phase I/II development, AstraZeneca’s MedImmune has been granted fast-track status for its candidate while Bavarian Pharma has a far earlier, pre-clinical candidate in development.
The market is expected to be huge, with Erck quoted as saying that it could be “the largest selling vaccine in the history of vaccines in terms of revenue”.
It came as Novavax revenue in the second quarter of 2015 increased 69% to $14.0 million, compared to $8.3 million for the same period in 2014. However, the company reported a net loss of $20.6 million for the second quarter of 2015, compared to a net loss of $17.9 million for the second quarter of 2014.
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