Pharmaceutical Business review

FDA grants orphan drug status for Viamet’s VT-1129 to treat cryptococcal meningitis

The company intends to submit an investigational new drug (IND) application for VT-1129 to the FDA in the first half of 2015.

In preclinical trials, VT-1129 has been shown to be a potent and selective, orally available inhibitor of fungal CYP51.

This antifungal agent blocks the production of ergosterol, an essential component of the fungal cell membrane, which is critical to fungal proliferation and survival.

The trials have also showed that VT-1129 has substantial potency against Cryptococcus species and high concentrations within the central nervous system.

The company said that based on these advantageous properties, it selected VT-1129 for further preclinical development targeting the treatment of cryptococcal meningitis.

Immunocompromised patients, including those with HIV, transplant recipients and oncology patients are the most affected people of this infection.