GSK Halts Herpes Vaccine After Phase 2 Failure

GSK has decided to halt the development of its therapeutic vaccine for herpes after the candidate, GSK3943104, failed to achieve the necessary results in a mid-phase clinical trial. The vaccine aimed to prevent recurrent symptom flare-ups in adults already infected with the herpes virus. This decision is based on the candidate not meeting the primary efficacy endpoint in its Phase 2 study.

GSK3943104 was the sole herpes treatment candidate in the infectious disease pipeline of GSK. Its design focused on preventing outbreaks of genital sores or blisters in those who already have the virus. However, in a Phase 1/2 proof-of-concept study, the vaccine did not significantly delay the time until the first confirmed episode of herpes simplex virus type 2 (HSV-2) compared to a placebo. The Phase 2 segment of the study involved 240 individuals aged between 18 to 60, all of whom had recurrent genital herpes with at least three episodes in the past year.

Despite the setback, GSK has stated it will continue routine safety monitoring of the trial participants but will not proceed to Phase 3 studies with this vaccine. Nonetheless, the company intends to use the data obtained from this failed study to guide future research and development efforts in the fight against herpes.

Genital herpes, predominantly caused by HSV-2, affects approximately 491 million people globally, according to the World Health Organization (WHO). Although a cure is currently unavailable, existing treatments can help prevent or shorten outbreaks and reduce the likelihood of transmitting the infection to sexual partners. Additionally, HSV-2 has been associated with an elevated risk of cervical cancer.

The field of herpes vaccine development is seeing activity from various other companies. In May, Moderna completed the enrollment of 300 participants for its Phase 1/2 trial of mRNA-1608, a vaccine aimed at adults with recurrent HSV-2 genital herpes. BioNTech started a Phase 1 trial of its prophylactic vaccine candidate in 2022.

Smaller biotech firms are also making strides in this area. Germany’s AiCuris has advanced its antiviral candidate, pritelivir, to Phase 3 trials for immunocompromised individuals who have resistant HSV forms. Meanwhile, Rational Vaccines, based in Woburn, Massachusetts, is developing more traditional attenuated live viral vaccines for herpes infections.

While GSK may be stepping back from their specific herpes vaccine program, the broader research landscape remains active, with multiple companies exploring and developing new vaccines and treatments that could potentially transform how this widespread and persistent infection is managed. The findings and experiences from GSK's halted trial may yet contribute valuable insights to the ongoing quest for effective herpes therapies.

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