Scynexis Gets FDA Fast Track Designation For Oral Formulation Of SCY-078

(RTTNews) - Drug discovery and development company SCYNEXIS, Inc. (SCYX) said the U.S. Food & Drug Administration or FDA has granted Fast Track designation 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. Currently, SCYNEXIS is screening patients for a Phase 2 trial of the oral formulation of SCY-078 and anticipates to enroll the first patient in the first quarter of 2015.

"This Fast Track designation, coupled with our prior receipt of QIDP designation, allows for an accelerated path to approval and underscores the FDA's understanding of the critical need for new and varied treatments for life-threatening invasive fungal infections," said Yves Ribeill, President and Chief Executive of SCYNEXIS. He continued, "We now have multiple trial sites open and we look forward to reporting complete data in the first half of 2016."

The FDA's Fast Track Drug Development Program is a process designed to aid the development and expeditious review of drugs to treat serious conditions and fill an unmet medical need. This designation allows for companies to interact with the FDA review team frequently to discuss critical development issues such as study design, required safety data necessary to support approval, and structure and content of a New Drug Application.

Moreover, should the FDA determine that a Fast Track product may be effective after their preliminary evaluation of clinical data submitted by a sponsor, the FDA may also consider reviewing portions of a marketing application before the sponsor submits the complete application.

SCY-078, formerly known as MK-3118, is an oral glucan synthase inhibitor being developed for the treatment of invasive fungal infections including Candidemia and invasive Aspergillosis.