Valley fever drug fast-tracked by FDAPosted: Updated:
TUCSON, Ariz. -- A drug that Tucson doctors are developing to cure valley fever is on track to go into clinical trials next year thanks to a fast-track designation from the Food and Drug Administration.
Nikkomycin Z, NikZ for short, is an antifungal drug. The FDA approved the University of Arizona's request to designate NikZ as a "qualifying infectious disease product" (QIDP).
Those four letters are a big deal.
"Getting a QIDP designation is huge for our program," said John Galgiani, MD, director of the University of Arizona Valley Fever Center for Excellence, project leader for the NikZ development team and chief medical officer for Valley Fever Solutions (VFS), the Tucson start-up that is handling the drug's development. "It makes NikZ much more attractive to investors because of the added protection and other benefits that come with this designation."
QIDP is an essential element of the GAIN Act, which Congress approved in 2012 to encourage drug manufacturers to develop medications for hard-to-treat bacterial and fungal infections like valley fever. The designation gives companies that get such drugs into clinical use an additional five years of protection from competitors. Not only is that good for the companies, it also is good for investors.
"This is especially valuable for NikZ development because it is an old drug and most of its patent protection already has expired," Galgiani explained.
"This extended market exclusivity makes our Nikkomycin-Z effort much more attractive to investors, a major goal of the GAIN act," said David Larwood, CEO of Valley Fever Solutions. "This brings us much closer to our dream of commercializing this promising compound."
NikZ was already designated "an orphan drug," which is a medication that is used only for a relatively uncommon disease. Although valley fever is well-known in Arizona and the Southwest, it is almost never found elsewhere in the country. Arizona's Maricopa, Pinal and Pima counties are known as the "Valley Fever Corridor."
According to the UA Valley Fever Center for Excellence, fewer than 2000,000 people in the entire country are sick from the infection at any given time.
Valley fever, known to doctors and researchers as coccidioidomycosis, is a potentially serious fungal infection of the lungs. There is no cure. While most people who inhale the spores that cause valley fever never exhibit symptoms, those who do get sick can face a long road to recovery. For some, valley fever can be deadly.
Common symptoms include fatigue, a persistent cough, chest pain, fever, rash, headache and joint aches. Because those symptoms can be caused by other illnesses, a lab test is required to confirm a valley fever diagnosis.
Discovered in the 1970s, NikZ blocks the enzyme that makes an important building block in fungal cell walls. When tested in mice in the '80s, it appeared to cure valley fever with few, if any, adverse effects.
Clinical development of the drug stalled in 2000 when the California-based company behind it failed. Nobody else wanted to continue the work because of NikZ's status as an orphan drug. The market for it would be limited, the profits not big.
The UA Valley Fever Center for Excellence picked up the program in 2005 and has been working to bring NikZ to market. The upcoming clinical trials are a big step and the potential investors from NikZ's new QIDP designation will help.
The Valley Fever Center for Excellence will host special free events in observance of Valley Fever Awareness Week 2014, Nov. 8-16. The events provide opportunities for the public and health professionals to hear experts and ask questions about valley fever.
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