Scynexis has been granted fast-track designation by the U.S. Food & Drug Administration (FDA) for the oral formulation of SCY-078, the company's novel antifungal product in development for the treatment of invasive Candidiasis, including candidemia and invasive aspergillosis.
Scynexis is currently screening patients for a phase II study of the oral formulation of SCY-078 and expects to enroll the first patient in the first quarter of 2015.
The fast-track designation and the company's prior receipt of qualified infectious disease product designation allow for an accelerated path to approval, according to Yves Ribeill, PhD, president and CEO of Scynexis. They underscore the FDA's understanding of the critical need for new and varied treatments for life-threatening invasive fungal infections, he added.
"We now have multiple trial sites open, and we look forward to reporting complete data in the first half of 2016," Ribeill stated in a press release.
