GSK plc (LSE/NYSE: GSK), a leading pharmaceutical company, has announced the discontinuation of its phase III development plans for the herpes simplex virus (HSV) vaccine candidate, GSK3943104, after it failed to meet the primary efficacy objective in the phase II trial.
The announcement was made today, following a comprehensive analysis of data from the phase II segment of the TH HSV REC-003 trial, which evaluated the therapeutic vaccine's potential efficacy.
The phase I/II proof-of-concept study aimed to assess the clinical efficacy of GSK3943104 before advancing it to further clinical development. The results indicated that the vaccine candidate did not achieve the anticipated efficacy, leading to the decision not to proceed with phase III studies. However, the company reported that no safety concerns were observed during the trial.
Despite this setback, GSK emphasized the continued need for innovative treatments for genital herpes, a condition with significant unmet medical needs. The company plans to thoroughly review the data from this and other studies to guide future research and development efforts within its HSV program.
The TH HSV REC-003 study will carry on for routine safety monitoring and to collect follow-up data, which may provide valuable insights into the management of recurrent genital herpes. GSK is coordinating with investigators to communicate the trial's outcome to participants.
GSK, known for uniting science, technology, and talent to combat diseases, reaffirms its commitment to addressing the challenges posed by genital herpes and advancing its research initiatives in the field.
The information in this article is based on a press release statement from GSK plc, as filed with the Securities and Exchange Commission.
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