Merck Reports Positive Phase 1/2 Study Results for V116 Vaccine

By Colin Kellaher

Merck & Co. on Tuesday reported positive results from a Phase 1/2 study of V116, the company's investigational 21-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults.

The Kenilworth, N.J., drugmaker said V116 met the primary immunogenicity objectives in vaccine-naive adults ages 18 to 49 (Phase 1) and in those 50 and older (Phase 2).

Merck also said V116 was well-tolerated, with an overall safety profile generally comparable to its Pneumovax 23 vaccine across both age groups.

The company said it plans to start a broad Phase 3 clinical program for V116 in vaccine-naive and vaccine-experienced adults next month.

Merck's V116, which includes eight serotypes not covered by currently approved vaccines, is designed to address strains of disease-causing pneumococcal bacteria that are most prevalent in adults and targets serotypes that account for 85% of all invasive pneumococcal disease in individuals ages 65 and up in the U.S. as of 2019.

Merck in April received U.S. Food and Drug Administration breakthrough-therapy designation, which aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies, for V116.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

June 21, 2022 07:41 ET (11:41 GMT)

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