Novavax anti-RSV vaccine fails to meet primary endpoint in a phase III trial

Maryland Stocks Novavax are down 66% in morning trading after the company announced its Respiratory Syncytial Virus (RSV) vaccine called ResVax failed to achieve its primary endpoint in a phase III trial.

In the PREPARE advanced phase study, ResVax, a recombinant nanoparticle fusion vaccine with RSV fusion protein (RSV), was being tested in infants with lower respiratory tract infection (RSV). ) by the VRS. Data from the Phase III trial showed that ResVax did not achieve its primary goal of preventing serious RSV infection medically for 90 days. However, the company said the trial had shown efficacy compared to a secondary goal of hospitalization for RSV-LRTI. This makes ResVax the first RSV vaccine to demonstrate efficacy in Phase III, the company said. The data also showed that the drug behaved well against RSTI-LRTI with severe hypoxemia, an abnormally low level of oxygen in the blood.

Stanley C. Erck, President and CEO of Novavax, said that even though the study did not meet the predefined success criteria, the trial data indicate that ResVax protects infants from the consequences. the most serious of the VRS, including the VRS. LRTI hospitalizations and RSV LRTI with severe hypoxemia. The trial showed that ResVax reduced all-cause hospitalizations with LRTI by 25% and severe cases of all-cause hypoxemia by 39% – in infants seen in the first 180 days of life. The data also showed that vaccinated mothers at 28 to 33 weeks of pregnancy had 53% vaccine efficacy rates for hospitalization of LRTI-LRV and 70% severe RSV hypoxemia during the first 90 days of pregnancy. the life of their baby. This was compared to 26% and 44% for mothers vaccinated after 33 weeks of pregnancy, the company said.

"The possibility of preventing these most serious consequences during the most vulnerable months of early childhood could have a profound impact on the global burden of disease at RSV," Erck said in a statement.

The company plans to meet with regulators in the United States and Europe to discuss the way forward for ResVax.

RSV is the most common cause of viral pneumonia in young children, and the leading cause of death for children under five in the world. In the United States, the RSV is the leading cause of hospitalization of infants, with an estimated annual caseload of about 76,000. Keith Klugman, director of the Bill & Foundation Pneumonia Treatment Program Melinda Gates, said ResVax was promising in the fight against RSV. The Gates Foundation financially supported the Phase III trial.

"We are very encouraged by the fact that Novavax's RSV vaccine has reduced severe RSV hypoxemia by 60% in the first months of life, and we believe this vaccine has considerable potential to reduce deaths associated with RSV in young babies, "Klugman said in a statement.

Novavax intends to present additional results of the Prepar test at an upcoming medical meeting.