The Janssen Pharmaceutical Companies of Johnson & Johnson announced it will present data from six company-sponsored studies in support of their respiratory syncytial virus (RSV) adult vaccine candidate at the Eighth European Scientific Working Group on Influenza (ESWI) meeting. The cornerstone of Janssen’s presence at ESWI will be a series of presentations detailing findings from the Phase 2b CYPRESS trial in adults at increased risk for RSV.
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“There is no vaccine or broadly indicated antiviral treatment available for RSV in older adults, and the threat of RSV remains critical,” said Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC. “We are proud to be leading the charge in developing a potential vaccine to help address unmet need, and look forward to presenting new data from our Phase 2b CYPRESS study. Topline results showed our RSV vaccine candidate met its primary and secondary safety and efficacy endpoints, which is a significant step forward as we continue to research a preventive option to protect against lower respiratory tract disease associated with RSV.”
In addition to detailed findings from the CYPRESS study, a late-breaker abstract detailing the humoral immune response elicited by Janssen’s RSV adult vaccine will be presented. Immunogenicity data from a Phase 1/2a trial of this vaccine will also be shared.
Janssen RSV vaccine candidate is currently in Phase 3 trials. The Company announced the initiation of the EVERGREEN study in October to evaluate its vaccine candidate versus placebo in approximately 23,000 adults aged 60 years and older throughout North America and a selection of countries across Europe, Asia and the Southern Hemisphere.
In September 2019, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for Janssen’s RSV adult vaccine candidate for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years or older. This was based on clinical data indicating the potential for substantial improvement compared to available standard of care on a clinically significant endpoint(s).