Ann Arbor-based NanoBio Corp. Wednesday announced the initiation of two Phase 3 trials evaluating its drug candidate NB-001 as a topical treatment for cold sores, a step forward in its over-the-counter drug licensing agreement with GlaxoSmithKline Consumer Healthcare.
In December 2009, GSK CH licensed exclusive rights in the United States and Canada to NB-001 for the OTC treatment of cold sores. GSK currently offers the market-leading cold sore treatment Abreva, the only OTC medicine approved by the Food & Drug Administration to shorten cold sore healing time.
The two trials of NB-001 will be conducted in 1,700 subjects at 72 clinical sites and will evaluate the effectiveness of NB-001 to reduce cold sore healing time.
“Based on the efficacy of NB-001 in Phase 2, we are very optimistic about these trials and the path to FDA approval,” said Mary Flack, M.D., vice president of clinical research, NanoBio. “Cold sores are painful and embarrassing for the roughly 20 percent of the U.S. population that suffer from them. The initiation of these trials marks a significant step towards the commercialization of a new treatment offering for cold sores, as well as potential other new offerings to come from our nanoemulsion-based platform technology.”
The trials are currently enrolling and are expected to conclude in 2012.
NanoBio is a privately held biopharmaceutical company focused on developing and commercializing dermatological products, anti-infective treatments and intranasal vaccines derived from its patented NanoStat technology platform. The company’s lead product candidates are treatments for herpes labialis (cold sores), onychomycosis (toenail fungus), acne, cystic fibrosis and a broad platform of intranasal vaccines. The company’s headquarters and laboratory are located in Ann Arbor.