Novavax reports positive top-line data from PhII trial of RSV vaccine
|Dr. Greg Glenn, Novavax SVP of R&D|
There is no vaccine for respiratory syncytial virus (RSV), which causes 177,000 hospitalizations and 14,000 deaths each year in adults older than 65. But early data from Novavax's ($NVAX) Phase II trial of its RSV candidate show its promise in protecting older adults.
The company announced on Monday that its candidate prevented 64% of severe RSV cases. It fared less well in preventing all symptomatic RSV cases (44% efficacy) and RSV disease with lower respiratory tract symptoms in older adults (46% efficacy).
"These efficacy data represent a historic advance for the field. … It is clear that our RSV F Vaccine provided statistically significant efficacy in older adults, a population that historically has been difficult to protect," Novavax's R&D chief, Dr. Greg Glenn, said in a statement.
The trial enrolled 1,600 older adults at 10 sites in the U.S. It compared the unadjuvanted 135-microgram dose of the RSV F Vaccine to placebo, and it is the first trial to show efficacy of an active RSV immunization in any clinical trial population, Novavax said in the statement.
|Novavax CEO Stanley Erck|
"The development of an RSV vaccine has been a decades-long challenge," Stan Erck, Novavax CEO, said in the statement. "We are thrilled by the groundbreaking efficacy of our RSV F Vaccine in older adults. We are committed to pursuing an aggressive developmental timeline for this program, which includes discussions with regulatory authorities and initiation of a pivotal Phase III trial as early as the fourth quarter of this year."
The candidate is in a second Phase II trial involving pregnant women to assess its safety and immunogenicity in infants via maternal immunization.
Novavax won fast-track designation from the FDA for its candidate in November 2014 and was soon followed by AstraZeneca's ($AZN) MedImmune, whose candidate got fast-tracked in April this year. There is no vaccine or specific treatment for RSV, but AstraZeneca does market Synagis, a monoclonal antibody for use in limited cases that will go off patent in October.
- read the release
- here's FierceBiotech's take
AstraZeneca's MedImmune gets RSV candidate fast-tracked
Novavax jumps on positive PhII for RSV vaccine