A drug developed at the University of Arizona that could cure valley fever has been fast-tracked by the FDA, university officials said Thursday.
The anti-fungal drug nikkomycin Z (NikZ) has been in development at the UA since 2005. But researchers have had trouble getting support for it because while valley fever is common in Arizona, it is a rare disease outside the Southwest.
The decision by the U.S. Food and Drug Administration to designate NikZ as a “qualifying infectious disease product” is significant and positive news to the team that’s been working to get the drug to market.
A clinical trial is scheduled to begin in 2015, and the UA has licensed development rights to a Tucson startup called Valley Fever Solutions Inc. The “qualifying infectious disease product” designation for a drug adds an additional five years of market exclusivity, which means the company that brings the drug into clinical use is protected from competitors for that period, UA officials said in a news release.
“This brings us much closer to our dream of commercializing this promising compound,” David Larwood, CEO of Valley Fever Solutions, said in a prepared statement.
Dr. John Galgiani, director of the UA Valley Fever Center for Excellence and project leader for the NikZ development team, is the chief medical officer for Valley Fever Solutions. Galgiani was not immediately available for comment.
There is currently no cure for valley fever (coccidioidomycosis), which is caused by the coccidioides species of fungus.
The fungal spores become airborne when the soil is disturbed by winds, construction, farming or other activities. In susceptible people and animals, infection occurs when a spore is inhaled.
In a small percentage of cases, the respiratory infection causes serious illness and can be lethal.
The disease is often under-diagnosed because doctors aren’t familiar with it, and the symptoms are the same as pneumonia — fatigue, cough, fever and chest pain.
Serious cases are currently treated with antifungal medications.
NikZ is the first of a new class of anti-fungal drugs that attack the formation of “chitin,” a major component of the fungal cell wall, UA officials say.
Given to mice with the valley fever fungus, NikZ seemed to cure the infection.
The drug’s development was started in the 1990s by a small company in California but halted when the business failed. The NikZ program was inactive until it was acquired by the UA in 2005.
