Viamet Gets Orphan OK for Fungus Fighter

(from NC Biotech Center)
DURHAM, N.C. -- Durham’s Viamet Pharmaceuticals has been granted an orphan drug designation by the U.S. Food & Drug Administration for one of its lead drug candidates, an oral antifungal agent code-named VT-1129. Under the Orphan Drug Act, the FDA may confer the orphan drug designation on a therapy intended to treat a rare disease or condition, generally considered to be fewer than 200,000 people in the United States. Viamet is developing VT-1129 to treat cryptococcal meningitis, a life-threatening invasive fungal infection of the lining of the brain and spinal cord. The company expects to submit an investigational new drug (IND) application for VT-1129 to the FDA so it can begin testing in human clinical trials during the first half of 2015.


Orphan status means 7 years of exclusivity

The orphan drug designation could give Viamet seven years of exclusive market share upon FDA approval for the cryptococcal meningitis indication. The system is designed to encourage companies to go through the expense and hassle of developing treatments for rare conditions, even though the number of potential users of the therapy will be far smaller than for conventional, let alone blockbuster, drugs .

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Cryptococcal meningitis infection occurs most often in immunocompromised patients, including those with HIV, transplant recipients and cancer patients. A study published in February 2013 in the scientific journal PLOS ONE estimated that 3,400 people a year are hospitalized in the U.S. with the infection.
Robust pipeline includes agricultural potential

The Company’s lead product candidate, VT-1161, is an oral treatment for recurrent vulvovaginal candidiasis, an infection of the mucus membranes in women’s genitals for which there are no approved therapies in the United States.

VT-1161 is also being tested as an improvement on the safety, tolerability and effectiveness over current treatments for onychomycosis, a common fungal infection of the nail. 

Viamet spun out of the University of North Carolina at Chapel Hill in 2004 to commercialize a fungus-busting discovery called metalloenzyme medicinal chemistry. The company trademarked the platform Metallophile Technology.

 It’s being explored to stop fungal infections not only in humans, but also in crops. For example, in 2010 the privately held Viamet entered a collaborative agreement with Dow AgroSciences to let Dow test Viamet's proprietary technology against fungal infections of plants.

Viamet scientists also believe the company's Metallophile Technology might prove useful against some bacterial and viral infections.

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