VT-1598 has received orphan drug and Fast Track designations for the treatment of Valley Fever

VT-1598 is a novel oral agent that we are developing for the treatment of invasive fungal infections, including coccidioidomycosis, also known as Valley Fever, a common infection in the southwestern United States, northern Mexico and parts of South America. Typically presenting as a community-acquired pneumonia, Valley Fever is self-limited in the majority of patients. However, approximately 5-10% of patients will develop a more severe form of the disease and a certain percentage of these patients will develop chronic pulmonary infection that can also spread to other organs, such as the brain, spleen and bone, in some cases leading to death.

VT-1598 has shown high potency and selectivity in in vitro studies and is an orally administered inhibitor of fungal CYP51, a metalloenzyme important in fungal cell wall synthesis. In preclinical studies, VT-1598 has demonstrated a very broad spectrum of activity, covering Candida species, Aspergillus species and endemic species including Coccidioides immitis and Coccidioides posadasii, the pathogens that cause Valley Fever.

In in vitro studies, VT-1598 was significantly more potent against Coccidioides isolates than fluconazole. In preclinical models of Valley Fever, VT-1598 was significantly superior to fluconazole in treating the primary lung infection, as well as treating infection that had disseminated to the brain and spleen.

Opportunity

Approximately 150,000 patients in the United States contract Valley Fever each year, with approximately 5-10% of patients developing a more severe form of the disease and a certain percentage of these patients developing chronic pulmonary or disseminated disease, in some cases leading to death. Patients with more severe forms of the illness are typically treated with long-term fluconazole or itraconazole, although these therapies are not approved specifically for Valley Fever. Although current therapies are effective in some patients, they are often poorly tolerated and morbidity and mortality remain significant.

Current Status

VT-1598 has received orphan drug and Fast Track designations for the treatment of Valley Fever and has been designated a Qualified Infectious Disease Product (QIDP) by the U.S. Food and Drug Administration.  We are currently conducting IND-enabling studies for VT-1598.