Vical to move forward with antifungal treatment trial
The trial will be randomized and double-blind and determine the safety, tolerance levels and pharmacokinetics of VL-2397, which will include single and multiple dosing options in healthy volunteers at a single clinical site in the U.S.
VL-2397 is part of a possible new class of antifungal compounds developed to treat invasive aspergillosis, a leading cause of sickness and death in immunocompromised patients. This also includes recipients of transplants. In recent preclinical studies, VL-2397 has shown faster antifungal activity than any drugs currently on the market. It has also demonstrated the ability to combat azole-resistant fungal pathogens.
Current treatments on the market have limited efficiency. Between 50 and 60 percent of patients with invasive aspergillosis who have received allogenic hematopoietic stem cell transplants die within 12 weeks of the procedure. Furthermore, only one new class of antifungal medicines has been introduced in the last 30 years.
The U.S. Food and Drug Administration has designated VL-2397 as an orphan drug and granted it qualified infectious disease designation (QIDP) to treat invasive aspergillosis.