Provided under the 2012 US Generating Antibiotic Incentives Now (GAIN) Act, the QIDP designation allows the company to have priority review, eligibility for fast-track status, and an additional five years of market exclusivity in the US for SCY-078.
SCY-078, formerly MK-3118, is the company’s lead product and is currently entering into a Phase II trial.
The company said that SCY-078 has shown activity against the two main pathogens responsible for the majority of invasive fungal infections (IFI), Candida and Aspergillus species.
It is an oral and parenteral glucan synthase inhibitor developed for the treatment of IFI.
Scynexis president and chief executive officer Yves Ribeill said receiving the QIDP designation from the FDA gives the company even greater confidence as we advance SCY-078 towards Phase II clinical trials and eventually to the marketplace.
"Glucan synthase inhibitors have been very effective in treating invasive fungal infections in a hospital setting, but there is currently no oral formulation," Ribeill said.
IFI are serious, often life-threatening infections caused by a variety of fungal species and the most common IFIs stem from Candidiasis and Aspergillosis, responsible for about 85% of all invasive fungal infections in the US and Europe.