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SK bioscience submits pneumococcal vaccine Phase 3 study plan to FDA

Collected: 2023.12.11

Distributed: 2023.12.12

Source: Go Direct

[Courtesy of SK bioscience]

SK bioscience Co. said on Monday that it submitted an investigational new drug (IND) application for the Phase 3 clinical trial plan of GBP410, a pneumococcal conjugate vaccine jointly developed with global pharmaceutical company Sanofi, to the U.S. Food and Drug Administration (FDA).

In the clinical trial, the two companies will evaluate the safety and immunogenicity of the vaccine against an existing pneumococcal conjugate vaccine in healthy infants and children.

GBP410 is a protein-conjugate vaccine candidate created by attaching a specific protein to the polysaccharide capsule of pneumococcal bacteria, which cause pneumonia and invasive diseases.

SK bioscience anticipates that GBP410, encompassing 21 serotypes, or more than an existing pneumococcal conjugate vaccine, will have a stronger preventive effect.

Based on the Phase 2 clinical trial results, SK bioscience plans to complete Phase 3 trials targeting infants and children in multiple countries, including the United States, Europe, and South Korea, by 2027.

“With some 740,000 infants, children, and adolescents dying from pneumonia each year across the globle, we will contribute to global public health and grow as a market leader with GBP410,” SK bioscience President Ahn Jae-yong said.

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