GSK announced in September 2024 that it has completed the primary objective data analysis from the Phase II part of its TH HSV REC-003 trial. The trial is a combined Phase I/II proof-of-concept study to assess the potential clinical efficacy of GSK’s early-stage therapeutic herpes simplex virus (HSV) vaccine candidate, GSK3943104, before it progressed to further clinical development. The results indicate that GSK3943104 did not meet the study’s primary efficacy objective, which means it will not progress to Phase III studies.
GSK3943104 in study
The first-time-in-human (FTiH) study sought to evaluate the reactogenicity, safety, immune response, and efficacy of GSK’s investigational herpes simplex virus (HSV)-targeted immunotherapy. It was conducted in two parts; the first assessed different formulations in healthy participants between the ages of 18 and 40 years. The second part assessed the two formulations in participants between the ages of 18 and 60 with recurrent genital herpes.
Although no safety concern was observed, GSK3943104 did not meet the primary efficacy objective. However, the TH HSV REC-003 study will continue for routine safety monitoring and to generate follow-up data, which could offer valuable insights into recurrent genital herpes.
More innovation needed
GSK commented on the “unmet medical need and burden associated with genital herpes”, calling for “innovation in this area”.
“GSK intends to evaluate the totality of all these data and other studies to progress future research and development of its HSV programme.”
WHO states that around 3.7 billion people under the age of 50 have herpes simplex virus type 1 (HSV-1) infection; this is the “main cause” of oral herpes. An estimated 491 million people between the ages of 15 and 49 have herpes simplex virus type 2 (HSV-2) infection, the “main cause” of genital herpes. Although most HSV infections are “asymptomatic or unrecognised”, infection with HSV-2 “increases the risk of acquiring and transmitting HIV infection”.
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