What is the timeline for a Herpes Cure?

The most frequently asked question in our community?

What is the timeline for a Herpes Cure?

When will there be a herpes cure? There have always been companies working towards better treatments, vaccines, and cures for HSV-1 and HSV-2, and many have failed. But recently two events changed the possible timeline for a Herpes cure significantly:

In 2012, CRISPR was discovered by a group of scientists, namely Dr. Jennifer Doudna. CRISPR reduced the time and cost in gene editing by over 99%. Only 5 years later, the FDA approved the first gene therapy on the market called Luxturna, which partially cures a rare, but horrible eye disease that results in blindness. Today, we now have 3 organizations (Shanghai BDgene, Excision BioTherapeutics, and Fred Hutch Cancer Research Center) using gene editing to actually cure Herpes Simplex Virus.

In 2017, the therapeutic vaccine for herpes zoster, Shingrix, was approved by the FDA unanimously. This vaccine was significant in a number of ways. Firstly, it has the highest efficacy rating out of any therapeutic vaccine ever developed with a 91-97% efficacy in preventing zoster outbreaks for over 4.5 years after one 2-dose regiment. Secondly, the vaccine is a subunit vaccine, which typically are not as effective for therapeutic applications. However, the reason Shingrix in particular is a highly effective subunit vaccine was due to the adjuvant used. An adjuvant assists in boosting the immune response to a virus.

This why Shingrix is much more effective than the previous therapeutic vaccine for herpes zoster, Zostavax, which is live-attenuated and only has a 50-60% efficacy. The Sanofi Pasteur trials, for example, are utilizing an adjuvant for their 4 vaccines being tested for Herpes Simplex Virus, HSV-2.

Given these two developments in the past 10 years, it is only a matter of time before an effective therapeutic herpes cure, vaccine or gene therapy is released on the market. In terms of when exactly, either one will make it to market is harder to say.

If we look at how long the Shingrix vaccine was in trials, it lasted from Phase I in 2008 to FDA approval in 2017, so a total of 9 years. If the Sanofi Pasteur trials follow a similar trend, we’ll see their HSV-2 therapeutic vaccine on the market around 2029. In email communication with X-Vax last year, they indicated plans to begin Herpes cure clinical trials in 2022 and anticipated that trials will last about 7-10 years before being released on the market, so assuming 7-10 years from Phase I to market is reasonable.

The closest new treatments coming to market, however, would be a monoclonal antibody treatment (from either Heidelberg Therapeutics or United BioPharma both of which are in Phase 2 trials), 2nd a new more effective antiviral Pritelivir from AiCuris (currently in Phase 3 trials), or 3rd a new immunotherapy SADBE from Squarex (currently planned for Phase 3). All of which are estimated to hit the market in 2025.

Time flies, so we have to both be patient and advocate for a Herpes cure urgently.

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