Hallux Inc

Hallux is an innovative specialty pharmaceutical company focused on developing safe and highly effective breakthrough solutions for common infections of the toe, nail and foot. The Company’s lead therapeutic candidate, Hallux Subungual Gel (HSG) is a novel terbinafine topical dosage form for treating toenail fungus, the most common nail disorder seen by podiatrists and dermatologists. HSG is designed for atraumatic physician administration direct to nail bed infection sites. The product will soon commence a Phase 2 efficacy, tolerability, and PK study in more moderately infected patients enrolled from OrthoArizona, a premier foot and ankle institute serving the greater Phoenix area. It is estimated that Podiatrists treat over 7 million patients a year for toenail fungus using routine nail debridement and Rx/OTC topicals, none of which work very well. The gold standard remains terbinafine tablets (Lamisil®) dosed daily for three months; however, topicals are widely preferred due to the oral’s risk of systemic side effects, especially liver toxicity. Hallux believes HSG could provide patients a cure rate exceeding oral terbinafine without systemic risk or the burden of daily pills for many months. Hallux is focused on achieving FDA and global registration of HSG and providing patients the highly effective topical therapy they have long sought to cure the ugly, embarrassing, and sometimes painful fungal infection that so many people around the world have had to live with for years.