Closely-held Squarex will be seeking an end-of-Phase 2 meeting with the FDA in the first quarter of 2020 as a steppingstone for pivotal testing of its SQX770 topical treatment for the prevention of recurrent cold sores caused by the herpes simplex virus.
“Herpes simplex virus type 1 (HSV-1), which causes cold sores, is a very common infection. While there are products available to shorten the length of an outbreak once it occurs, there are no approved drugs to prevent outbreaks of cold sores,” Jack Talley, CEO, says in an interview with BioTuesdays.
In two randomized, double-blind, placebo-controlled clinical studies, the company demonstrated that SQX770 was effective in preventing recurrent cold sores around the mouth, including the lips, a condition also known as herpes labialis.
“One topical dose to the upper arm has been shown to prevent outbreaks for at least four months,” he contends. ”It can be applied between or during outbreaks and three-to-four applications a year have the potential to prevent or delay the recurrence of cold sores.”
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