VL-2397 (ASP2397) is part of a potential new class of antifungal compounds for the treatment of systemic fungal infections, which are major causes of morbidity and mortality in immunocompromised patients, such as transplant recipients, in patients undergoing chemotherapy and in patients in the ICU.
The QIDP designation provides certain incentives to develop new anti-infectives, including eligibility for priority review, the FDA’s Fast Track program, and a five-year extension of exclusivity under the Hatch-Waxman Act.
Duke University Medical Center Division of Infectious Diseases chief John Perfect said: "The high mortality rate and emerging drug resistance call for new therapeutic options for the treatment of invasive fungal infections.
"It is exciting to see an antifungal with a novel mechanism of action and with rapid fungicidal activity in preclinical models. There is an urgent need for new fungicidal drugs in the clinics."
In preclinical trials, VL-2397 has showed faster fungicidal activity than marketed drugs and activity against azole-resistant fungal pathogens.
Initially, VL-2397 was developed by Astellas Pharma and the company granted Vical an exclusive worldwide license to develop and commercialize the product in March 2015.
Vical Corporate Development senior vice-president Igor Bilinsky said: "We plan to file an investigational new drug application (IND) and initiate a Phase 1 clinical trial for VL-2397 in the first half of 2016."