New Clinical Trial for Herpes Simplex Virus

GlaxoSmithKline Pipeline Update

GSK has officially updated its clinical research pipeline to include a vaccine for HSV-2! Their therapeutic vaccine for HSV-2 isn’t mRNA (or what they called SAM technology) but an adjuvanted therapeutic vaccine.

The trial (currently recruiting) is a Phase 1/2 combined trial that ends in 2024. GSK will test 9 different formulations as a prophylactic, the one that has the highest efficacy will then be tested in Part 2 as a therapeutic. Ultimately, advocates assume, that GSK will make one vaccine as both a prophylactic/therapeutic.

GSK Formulation: GSK3943104A: Therapeutic HSV (Immunomodulator): Active Immunization to suppress recurrence of genital herpes in adults aged 18 years and older.

GSK is the manufacturer of Shingrix (shingles vaccine released in 2017) and is perfectly positioned to leverage their knowledge from this very effective vaccine for another herpes virus for a new formulation to treat Herpes Simplex. Shingrix is also a recombinant protein adjuvanted vaccine with 90-97% efficacy over 7 years with one 2-dose regimen.

GSK has a proven platform for developing a highly effective recombinant protein – adjuvanted herpes vaccine. They are now simply tweaking it slightly for a new target in HSV-2. HSV and VZV (VZV = Varicella-zoster virus the virus that causes chickenpox and shingles) are both alpha herpes viruses. They are genetically very closely related, are latent viruses that live in the body for life, and when reactivated exhibit symptoms in the body similarly. Both herpes simplex and zoster are viruses that hide in the nerve ganglia and reactivate on the skin in the same manner with blisters, prodrome, etc.

Advocates are excited that GSK is taking this approach and hopeful that as one of the largest pharma companies globally, and entering clinical studies for herpes simplex for the second time, they’re confident about the safety and efficacy of this formulation. The new formulation is estimated to reduce viral shedding to the extent that the infection would be non-transmissible to partners or what is known as a functional cure.

For other projects in the Herpes Cure Pipeline, see here.

For more details on the new GSK clinical trial for Herpes and to apply to participate please visit here.

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