Ladenburg Says No Need For Novavax To Rerun Failed Drug Study

Top-line Phase III data for Novavax, Inc’s NVAX RSV F nanoparticle vaccine for the prevention of RSV in the elderly was disappointing, Ladenburg’s Kevin DeGeeter said in a report. He downgraded the rating on the company from Buy to Neutral, and removed the price target.

Novavax presented top-line results from the Phase III RESOLVE study of its RSV F-protein vaccine in 11,856 adults age 60 years or older. Although the vaccine led to a reduction in symptomatic RSV infections, the result was not significant.

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“Similarly, results from the 1,329-subject Phase IIb booster dose study in previously vaccinated elderly adults failed to show a reduction in moderate-to-severe RSV-associated lower respiratory tract infections,” analyst DeGeeter wrote.

Takeaways

DeGeeter enumerated three takeaways from the latest data release:

• Good: Result was unambiguous
• Bad: Current vaccine formulation and schedule are not active in elderly
• Ugly: Results led to concerns over the role of palivizumab-like antibodies in preventing RSV

The results have “negative implications for an ongoing maternal vaccination study,” the analyst pointed out.

Novavax is expected to release data on palivizumab-like antibodies during its October 11 analyst day. DeGeeter wrote, “In short, we expect the data to suggest patients developed elevated palivizumab-like antibodies but did not achieve protection against RSV infections, which, in our view, would cast a cloud over mechanism of action for the ongoing study in maternal subjects.”

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