VL-2397 (formerly known as ASP2397) is a novel antifungal drug initially developed by our partner, Astellas Pharma. This drug was isolated from a leaf litter fungus Acremonium species collected in a Malaysian national park. Astellas presented two posters at the 2014 ICAAC meeting which described the in vitro and the in vivo antifungal activities of this drug. The differentiating attributes from the preclinical data of VL-2397 include:
- A novel mechanism of action, with a potential to be complementary or synergistic with the existing classes of antifungals.
- Rapid fungal cell kill activity demonstrated in preclinical models, which was faster than marketed antifungals.
- Activity against azole-resistant fungal species.
- Low propensity for P450 drug-drug interactions.
The investigational product has completed dosing in a Phase 1 clinical trial. The randomized, double-blind trial was designed to evaluate safety, tolerability and pharmacokinetics of VL-2397 at single and multiple ascending doses in healthy volunteers at a single U.S. clinical site.