Vir Biotechnology’s Phase II PrevEntioN of IllNesS DUe to InfLuenza A (PENINSULA) trial of VIR-2482 has failed to meet primary or secondary efficacy endpoints.
The proof-of-concept, dose-ranging, outpatient trial assessed the monoclonal antibody VIR-2482 in patients with influenza A.
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It enrolled nearly 3,000 men and women aged 18 to 64 years who did not receive an influenza vaccination for the flu season.
A non-statistically significant reduction of nearly 16% in influenza A protocol-defined illness was observed in patients who received the highest (1,200mg) dose of VIR-2482.
Nearly 57% reduction in symptomatic influenza A illness, as defined according to CDC influenza-like-illness criteria, was demonstrated in participants who received the highest dose, one of two secondary endpoints.
The proportion of participants with WHO-defined influenza-like-illness with PCR-confirmed influenza A infection is the other secondary endpoint of the study.
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By GlobalDataVir Biotechnology executive vice-president, chief medical officer and interim head of research Phil Pang said: “Although these topline data are disappointing, further analysis is necessary to better understand these outcomes, which we plan to present at a major medical congress.
“In the meantime, we are continuing to advance next-generation solutions for serious respiratory infections, including VIR-2981, an investigational neuraminidase-targeting monoclonal antibody against both influenza A and B viruses.”
Treatment with VIR-2482 was found to be well tolerated with no safety signals identified.
Vir Biotechnology CEO Marianne De Backer said: “I’m very excited about the future ahead, with the opportunities that we have, including a robust pipeline, where we expect two data readouts across our hepatitis B and hepatitis D programmes in 2023.
“We also have a strong balance sheet with approximately $1.9bn in cash and investments, as of the end of the second quarter, which will allow us to invest in our ongoing development and future innovation.”
