Merck presents positive results from phase-II/III study

Merck yesterday announced the presentation of positive results from the phase-I/II study, V116-001, evaluating the safety, tolerability and immunogenicity of V116, the company’s investigational 21-valent Pneumococcal Conjugate Vaccine (PCV), in pneumococcal vaccine-naïve adults 18-49 years of age (phase-I) and 50 years of age and older (phase-II). In both populations, V116 met the primary immunogenicity objectives and was well-tolerated with an overall safety profile generally comparable to Pneumovax23 (Pneumococcal Vaccine Polyvalent) across age groups. In the phase-II part of the study, V116 demonstrated non-inferior immune responses to Pneumovax23 for all shared serotypes, and superior immune responses for the serotypes included in V116, but not included in Pneumovax23, based on study-defined criteria. Responses were measured 30 days post-vaccination by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs), a measure of functional antibody activity, the company said in a statement.

Data from V116-001, in addition to other data from the company’s pneumococcal vaccines portfolio, are being featured at the International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-12) taking place in Toronto from 19th to 23rd June, 2022. The full study results from V116-001 will be published in a scientific journal in the future, the statement added.

It also said that earlier this year, V116 received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for the prevention of Invasive Pneumococcal Disease (IPD) and pneumococcal pneumonia caused by streptococcus pneumoniae serotypes 3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, 35B in adults 18 years of age and older. This includes eight serotypes not included in any currently licensed pneumococcal vaccine, it added.

“Our encouraging data at ISPPD reflect the potential of V116 and Merck’s tailored approach to developing pneumococcal vaccines to meet the specific needs of different populations. Consistent with our portfolio strategy, V116 is designed to specifically target serotypes that are responsible for 85 per cent of all invasive pneumococcal disease in individuals aged 65 and over in the United States as of 2019. Importantly, the eight serotypes in V116 that are not included in any currently-licensed pneumococcal vaccine account for over 30 per cent of this disease burden alone,” said Dr Eliav Barr, Senior Vice President, Head, Global Clinical Development and Chief Medical Officer, Merck Research Laboratories, in the statement.