SQX770 is a topical immunotherapy that has completed a Phase 1/2, larger Phase 2, and Mechanism of Action clinical trial for HSV-1 and HSV-2 (oral and genital). Phase 2b and Phase 3 trials are planned for the coming year. The company conducting the clinical trials is Squarex Pharmaceuticals.
This immunotherapy is applied to the inner bicep (arm) to induce a systemic (i.e. throughout the body) immune response to HSV-1 and HSV-2. Specifically, SQX770 is a contact immunotherapy that works by introducing an allergen (SADBE) to the body via the skin. This allergen tricks the body into thinking that a foreign pathogen is invading (which is how allergies work), and as a result, the immune system begins to mass produce T-cells to fight this foreign invader. This immune response by SQX770 is very similar to the one induced by poison ivy. In particular, SQX770 upregulates interferon gamma, a cytokine produced by T-cells that is essential in suppressing HSV. Those are naturally asymptomatic with HSV (about 87% of the infected population) have very highly upregulated interferon gamma levels.
Results of the clinical trials:
(1) Phase 1/2: An initial application of SQX770 resulted in a 67% reduction in OB frequency over the 4-month period afterwards, with over half of participants experiencing a 100% reduction in OB frequency.
(2) Larger Phase 2: An initial application of SQX770 resulted in a 62% reduction in OB frequency over the 4-month period afterwards.
(3) Mechanism of Action: An initial application of SQX770 showed that the immunotherapy boosted T-cell immunity, upregulated interferon gamma gene expression, and enhanced viral antigen recognition (which is why SQX770 is effective for different viruses, such as HSV-1, HSV-2, and HPV).
A more detailed summary of the trials can be found by reading Squarex's White Paper.
Some common questions and associated answers:
(1) Why does Squarex advertise SQX770 as an immunotherapy for oral herpes (cold sores)? Will it work for other types of herpes?
Yes, it will work for all types of herpes, because the immune response induced by the immunotherapy is systemic. It functions like a therapeutic vaccine. The reason Squarex is marketing this therapy for oral herpes is because Valtrex (valacyclovir) is already marketed for genital herpes. In other words, legally, Squarex can state that SQX770 is the first treatment on the market that can prevent cold sores. The company cannot say the same for genital herpes since Valtrex (valacyclovir) is already marketed as a preventative for genital herpes outbreaks when used suppressively. This is nuanced bullshit, but I get it, since the company needs to maximize potential sales. I'd like to note that their White Paper states how their clinical trials enrolled individuals with HSV-1 and HSV-2 of all types.
(2) Why does Squarex want to run trials on SQX770 when it is already made at compounding pharmacies (in the US) to treat HPV (warts)?
Because 2% SADBE (SQX770) is not currently commercialized for any illness at the moment. In the United States, we have compounding pharmacies that will specially make a drug or treatment that is not commercialized or mass produced, because the demand for that drug is so low. For example, let's saw you were allergic to a particular compound used in making Valtrex. Well, GSK (who makes Valtrex) isn't going to find a substitute compound to help you out. But a compounding pharmacy will do so. As a result, you'll pick up your Valtrex prescription at this compounding pharmacy with the substituted ingredient. Over the decades, 2% SADBE has been used as an immunotherapy to treat warts, but there hasn't been any company to run trials on it for HPV (or HSV for that matter). Squarex is trying to commercialize this for HSV, so that they can mass produce it. So instead of picking it up at a compounding pharmacy, you instead pick it up at CVS, Rite Aid, or Walgreens as a mass-produced drug.
(3) Is SQX770 applied to the outbreak?
NO. It is only applied to the arm, because the immune response induced by it is systemic. You could put it on the outbreak, but the reaction rash caused by the immunotherapy may be a bit uncomfortable around your lesions.
(4) How long does one application of SQX770 boost the immune system for?
It begins to exert itself on the immune system 14-21 days after application, with the maximum immune response occurring after 43 days and lasting until 121 days after application.
(5) Will I have to take SQX770 forever?
Theoretically, no. Over time, the immunotherapy slowly builds up memory T-cells that will better control HSV reactivations over time. So, after years of use, it is expected to no longer need to take the immunotherapy.
(6) Can I take this with antivirals or supplements?
Sure, but it is unknown how they may interact with each other. I recommend taking the immunotherapy alone.
(7) How can people access this immunotherapy if it hasn't completed clinical trials yet?
Well, because it is already available for HPV at compounding pharmacies, anyone in the United States can get it prescribed off-label. The benefits of Squarex commercializing the therapy is that it will allow for better quality control and provide necessary information on dosing and safety for HSV.
(8) Will it reduce transmission?
In theory, yes. But Squarex is purely focused on marketing this therapy to those with chronic outbreaks. So the trials will only focus on efficacy regarding OB reduction.
(9) Is a reaction rash necessary for the immunotherapy to work?
Yes and No. For an initial application, a reaction rash usually does not occur, BUT the immunotherapy still triggers an immune response to HSV. Further applications however should cause a reaction rash. This is because the immunotherapy functions via a contact allergen, and like any allergen, the more exposure to it, the more severe and pronounced the immune response to it. If you are applying it the second or third time and still do not have a reaction rash, chances are your prescription was made incorrectly. On a personal level, I did not get a reaction rash the first time, but the therapy still worked and stopped my weekly outbreaks. The second time however I DID get a rash. The clinical trials from Squarex also show that a reaction rash for an initial application is not necessary.