PALO ALTO, Calif. ( TheStreet) -- Let's talk toenail fungus. I know, not exactly the most appealing topic but 36 million Americans suffer from onychomycosis, the disease's scientific name, making this a potential $250-300 million market opportunity for the tiny drug maker Anacor Pharmaceuticals (ANAC).
Anacor will be announcing results any day from the first of two phase III studies of tavaborole, a topical, once-daily treatment for toenail fungus. The studies enrolled 600 toenail fungus sufferers each, randomized to one year of treatment with tavaborole or the drug's alcohol-based delivery vehicle alone (essentially the placebo.)
The study's primary endpoint measures "complete cure" -- defined as the percentage of patients in each arm who are fungus free (mycologic cure) plus have completely clear nails after 52 weeks of treatment.
This is not the endpoint used in Anacor's phase II studies, which makes it difficult to predict the results from the ongoing phase III studies.Tavaborole's previous six-month mycologic cure rates from the phase II studies are in the 50-60% range so meeting this portion of the "complete cure" threshold shouldn't be too problematic.
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