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Valley Fever Treatment Granted FDA Fast Track Designation

Mathew Shanley
Published Online: Friday, Jul 14, 2017
This morning, Viamet Pharmaceuticals, Inc. announced that VT-1598, its novel oral agent for the treatment of coccidioidomycosis (Valley Fever) has been granted a Fast Track designation by the U.S. Food and Drug Administration (FDA).
 
Valley Fever is an infectious disease caused by Coccidioides, a fungal pathogen, found primarily in the soil in the Southwestern U.S., parts of Mexico, Central and South America; the condition is heavily concentrated in those areas. Between 5-and-10% of patients are likely to develop a devastating and possibly fatal form of the disease, associated with lung infection and transmission to other body parts.
 
Early symptoms of the disease resemble that of the flu, like the fever, cough, chest pains, chills, night sweats, headaches, fatigue, joint aches, and rashes.
 
"The FDA's decision to award Fast Track designation to VT-1598 highlights the high unmet needs in the treatment of Valley Fever, and provides a process for Viamet to work closely with the FDA to bring this treatment to patients in an expedited manner," said Robert Schotzinger, M.D., Ph.D., President and CEO of Viamet in a press release.
 
"Each year, approximately 5-10% of the patients that contract Valley Fever develop chronic pulmonary or disseminated disease, which can be deadly. Preclinical studies have shown that VT-1598 has the potential to be a highly potent and highly selective antifungal agent with broad spectrum activity, and we look forward to continuing the advancement of this promising candidate."
 
VT-1598 is an inhibitor of fungal CYP51, intended to be taken orally, that has proven to have high potency versus a wide-ranging array of fungal pathogens, including molds, yeasts and multi-drug resistant fungal pathogens. Additionally, it has shown potency against a fungal class typically known as endemic fungi, which includes Coccidioides, Histoplasma and Blastomyces species. VT-1598 prevents the production of ergosterol, one of the fungal cell membrane’s indispensable constituents.
 
It is believed that VT-1598 could avoid the side effects, like liver toxicity and drug-drug interactions, that limit the use of current oral antifungal therapies (i.e., amphotericin B or ketoconazole).
 
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