Merck Reports Positive Phase 1/2 Study Results for V116 Vaccine
June 21 2022 - 07:56AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 21, 2022 07:41 ET (11:41 GMT)
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