GSK plc has announced that it has completed the primary objective data analysis from the phase II part of the TH HSV REC-003 trial. This trial is a combined phase I/II proof-of-concept study to assess potential clinical efficacy of GSK3943104, an early-stage therapeutic herpes simplex virus (HSV) vaccine candidate, before progressing it for further clinical development.
Results show that GSK3943104 did not meet the study’s primary efficacy objective. This vaccine candidate, therefore, will not progress to phase III studies. No safety concern was observed. The TH HSV REC-003 study will continue for routine safety monitoring and to generate follow-up data that could offer valuable insights into recurrent genital herpes. GSK is working closely with investigators to inform trial participants.
Given the unmet medical need and burden associated with genital herpes, innovation in this area is still needed. GSK intends to evaluate the totality of all these data and other studies to progress future research and development of its HSV programme.
