Squarex, a clinical-stage pharmaceutical company developing a topical immunomodulator for the long-term prevention of recurrent cold sores and other infections caused by herpes simplex viruses, today announced positive results from a Phase 2 study of its investigational compound SQX770
| ST. PAUL, Minn., Aug. 5, 2019 /PRNewswire/ -- Squarex a clinical-stage pharmaceutical company developing a topical immunomodulator for the long-term prevention of recurrent cold sores and other infections caused by herpes simplex viruses, today announced positive results from a Phase 2 study of its investigational compound SQX770, a topical formulation of the immunomodulator squaric acid dibutyl ester (SADBE), in patients with recurrent herpes labialis. The company intends to initiate a Phase 3 clinical trial following a planned FDA end of phase 2 meeting later this year. The multi-center, placebo-controlled, double-blinded randomized Phase 2 clinical trial involved 139 subjects who reported four or more herpes labialis episodes in the past 12 months. The study was designed to determine if the topical application of SADBE can delay outbreaks of HSV-1. Results from the Phase 2 study demonstrated that a single topical dose of SQX770 applied to the upper arm significantly extended time to next herpes labialis outbreak and reduced both the frequency and severity of outbreaks. The greatest effect was recorded during days 43 to 121 following the drug’s application. These findings suggest SQX770 immunotherapy can take up to 6 weeks to fully exert a clinically meaningful effect on the immune system. Groups of patients received 1 or 2 doses of SQX770 or placebo. During the span between days 43 and 121, both the 1-dose group, as well as the pooled treatment groups demonstrated statistically significantly superior results compared to the placebo group for the following endpoints:
No serious adverse events (SAEs) were reported. The adverse events (AE) that were reported, such as local reaction due to the sensitization and challenge responses on the skin were what investigators expected to see with a topical immunomodulator. “We are extremely pleased with the results observed in the Phase 2 trial of SQX770,” stated Jack Talley, Chief Executive Officer of Squarex. “Our findings confirm and validate the results from two previous studies including a previous placebo controlled clinical trial and therefore, pave the road for the initiation of a Phase 3 trial. With no current preventative treatment options on the market for the millions of patients who suffer from recurrent HSV-1 outbreaks, we are excited to continue the clinical development and hopefully becoming the first and only choice for combating herpes labialis – cold sores or oral herpes.” About SQX770 About Herpes Labialis About Squarex Contacts: Sharen Tilman (Investors) Johanna Bennett (Media)
SOURCE Squarex |
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