Beech Tree Labs has announced that the FDA has approved its IND for a Phase 1/2a clinical evaluation of BTL-TML-HSV, a novel therapeutic agent for treating recurrent oral herpes infections. The study will be a 210 patient, multi-site, placebo-controlled trial and is anticipated to begin later this summer.
According to WHO and CDC statistics, over 80% of the population has oral herpes with about 20% of these expressing symptoms. One in four adults has genital herpes, with the incidence steadily increasing.
Herpes simplex, the virus causing oral herpes, serves as the prototype of a Beech Tree Labs approach that potentially addresses a broad spectrum of herpes virus indications. The active agent is also embodied in a product candidate that recently received FDA approval of an IND targeting influenza, presenting evidence of a growing Beech Tree anti-viral platform.
Beech Tree Labs is a privately held biopharmaceutical company specializing in discovery and early-stage development through Phase 2 clinical trials, followed by licensing to larger pharmaceutical and biotech firms for late-stage evaluation and marketing. It is a leader in resonant molecular signaling technology and holds a number of patents on other potential therapeutics.