The study involved around 139 subjects who had reported four or more episodes of herpes labialis in the past 12 months

Squarex, a clinical-stage pharmaceutical company has reportedly unveiled the positive results from a Phase 2 clinical trial of its investigational compound, SQX770, which is a tropical formulation of the immunomodulator squaric acid dibutyl ester, in patients with oral herpes.

Apparently, the company aims to initiate a Phase 3 study after a planned FDA end of Phase 2 clinical meeting later in the year.

Sources close to the matter informed that the placebo-controlled, multi-center, double-blinded randomized Phase 2 study involved around 139 subjects who had reported four or more episodes of herpes labialis in the past 12 months. The study was formally designed to ascertain if the topical application of SADBE is able to delay HSV-1 outbreaks.

Seemingly, results from the Phase 2 clinical trial defined that a single topical dosage of SQX770 applied to the upper arm substantially extended time to subsequent herpes labialis outbreak and reduced both the severity and frequency of outbreaks. The greatest effect was registered during days 43 to 121 following the application of drug. These findings indicate SQX770 immunotherapy can take up to 6 weeks to completely exert a clinically significant effect on the immune system.

Sources further stated that no serious adverse events were reported so far. The adverse events that were officially reported, like local reaction owing to the sensitization and challenge responses on the skin, were what investigators anticipated to witness using a topical immunomodulator.

According to Jack Talley, Chief Executive Officer of Squarex, the company’s findings confirm and validate the results from two former studies including a prior placebo controlled clinical trial and therefore, open the way for the initiation of a Phase 3 clinical trial. With no existing preventative treatment options available on the market for the millions of patients who are suffering from recurrent HSV-1 outbreaks, Squarex is ready to continue the clinical development and could expectedly bring the first and only option for combating herpes labialis.

Source Credits: https://www.prnewswire.com/news-releases/squarex-announces-positive-results-from-completed-phase-2-study-of-sqx770-in-the-prevention-of-recurrent-herpes-labialis-300896065.html